Cancer Immunotherapy - Society for Immunotherapy of Cancer

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ABOUT THE Society for Immunotherapy of Cancer
The Society for Immunotherapy of Cancer (SITC) is the world’s leading
member-driven organization specifically dedicated to professionals working in the field of
cancer immunology and immunotherapy. Established in 1984, SITC is a 501(c)(3)
not-for-profit organization with a growing constituency of more than 800
academic, government, industry, clinical and basic scientists and medical
professionals from around the world. SITC’s mission is to improve cancer
patient outcomes by advancing the science, development and application of cancer
immunology and immunotherapy through core values of interaction/integration,
innovation, translation and leadership in the field. Learn more at www.sitcancer.org.
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TABLE OF CONTENTS Understanding Cancer Immunotherapy
CONTENTS
2
Immunotherapy in the News
3
Understanding the Basics of Immunotherapy
4
The Immune System and How it Works
8
Types of Immunotherapy by Strategy
13 Survivor Story: Steven Silverstein
Chief Executive Officer Mark A. Uhlig
Publisher
Linette Atwood
Co-Editor-in-Chief
Charles M. Balch, MD, FACS
Co-Editor-in-Chief Michael B. Atkins, MD
14 Talking With Your Doctor About Immunotherapy
15 Advocacy & Financial Resources
16 Clinical Trials in Cancer Immunotherapy
33 Glossary of Terms: The Immune System and Immunotherapy
Understanding Cancer Immunotherapy
Advisory Board
Charles M. Balch, MD, FACS
Professor of Surgery, University of Texas
Southwestern Medical Center
Editor-in-Chief, Patient Resource LLC
Michael B. Atkins, MD
Deputy Director, Georgetown-Lombardi
Comprehensive Cancer Center
Professor of Oncology and Medicine,
Georgetown University School of Medicine
Past President, SITC
Bernard A. Fox, PhD
Harder Family Endowed Chair for Cancer Research,
Robert W. Franz Cancer Research Center, Earle A.
Chiles Research Institute, Providence Cancer Center
Past President, SITC
Chair, World Immunotherapy Council
Howard L. Kaufman, MD, FACS
Chief Surgical Officer,
Associate Director for Clinical Science,
Rutgers Cancer Institute of New Jersey
President-Elect, SITC
John M. Kirkwood, MD
Usher Professor of Medicine,
Dermatology and Translational Science,
Co-Director, Melanoma and Skin Cancer Program,
University of Pittsburgh Cancer Institute
Member, SITC
Co-Editor-in-Chief John M. Kirkwood, MD
Senior Vice President Debby Easum
Vice President, Operations Leann Sandifar
Managing Editor Matt Smithmier
Writer Dana Schneider
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Co-Editor-in-Chief Howard L. Kaufman, MD, FACS
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1
9/17/2014 9:27:23 AM
IMMUNOTHERAPY in the news
Source: The New York Times, Los Angeles Times
You may have heard about a new and innovative cancer treatment
called immunotherapy. These treatments have given doctors new ways
to fight cancer. Reports from mainstream media show results that are
nothing short of miraculous: patients going into remission, many living longer and some even thought to be cured. Some of the agents for
this treatment are so new, in fact, that many of these results come from
patients participating in clinical trials, the research studies of drugs or
treatment combinations that are not yet FDA-approved.
What is this immunotherapy? Is it a cure,
can I get it, and will it work for me? Is it true
there are no side effects? Simply stated, immunotherapy is a type of treatment that uses
your own immune system to attack your cancer. Just as the immune system attacks foreign
germs, such as bacteria and viruses, it can
also attack cancer cells. This rids the body of
defective or abnormal cells, whether infected
by a virus or changed because of cancer. Basically, “immuno” (from the immune system)
+ “therapy” (treatment) = “immunotherapy.”
Cancer cells are cells that have originated from the tissues of the body that have
damaged DNA and therefore grow out of
control. Because they come from the body,
however, these cells can trick your immune
system into thinking they aren’t a threat by
2
turning off the immune response or stopping the immune functions that might
otherwise destroy them. Immunotherapy
uses different ways to reverse those tricks,
allowing the immune system to respond
as it should and attack the cancer. Recent
breakthroughs have been made specifically
in the treatment of melanoma and prostate
cancer and have begun to show promise in
the treatment of lung, kidney, cervical, head
and neck, and several other types of cancer.
You may have recently heard about immunotherapy drugs such as pembrolizumab
(Keytruda), interleukin 2 (Proleukin), sipuleucel-T (PROVENGE), ipilimumab (Yervoy)
and nivolumab. These drugs are types of immunotherapy that focus on re-engaging different parts of the immune system to combat
cancer. Studies of patients with advanced melanoma have shown that they are living longer,
with up to 20 percent showing no signs of cancer years after treatment has been completed.
Many of the patients treated in these trials had
already tried other aggressive forms of treatment and had only a few remaining options.
The results have been unprecedented in the
history of melanoma treatment, and immunotherapy has quickly moved into the spotlight.
As far as side effects: Most cancer treatments have the potential for side effects, and
immunotherapy is no different. However,
because immunotherapy is unlike other
treatments, so is your body’s response. In
fact, some patients experience only minimal
side effects, if any. Because immunotherapy affects the immune system, however,
some patients have suffered from a range
of immune-related adverse effects that have
needed immediate attention. The good news
is that most of the side effects commonly
associated with immunotherapy are readily
treatable if recognized early.
Immunotherapy and the immune system
are both very complicated, and scientists are
learning more about both every day. If you
or someone you know is considering this
type of treatment, it’s important to understand as much as you can so you can make
informed decisions about your comprehensive cancer care. n
P a t i e n t Reso ur ce.co m
9/17/2014 9:27:27 AM
UNDERSTANDING THE BASICS of immunotherapy
I
mmunotherapy is a type of cancer
treatment that seeks to stimulate
your own immune system to fight
cancer. Because cancer cells have the
ability to evade the immune system
by using a number of clever techniques (see
page 6), the application of immunotherapy is
based on understanding these techniques
and using them to restore the immune system’s ability to destroy tumors.
Immunotherapy is a rapidly evolving
field, different from any previous “standard” cancer treatments, such as chemotherapy, radiation therapy and surgery.
Chemotherapy uses drugs to kill rapidly
multiplying cells, which includes cancer
cells but sometimes healthy tissue as well.
The destruction of healthy cells and tissues
often leads to the side effects commonly
associated with chemotherapy, including
hair loss, nausea and vomiting, and low
blood cell counts. Radiation therapy, which
targets a specific region of the body, uses
high-energy X-rays to destroy cancer cells.
While often very effective, it’s not guaranteed to kill all of the cancer cells and usually
involves the destruction of nearby healthy
tissue as well. Surgery to remove a tumor,
although common, can be invasive and may
leave behind cancer cells that have the potential to develop into new tumors.
Targeted therapy goes after specific mutations in the DNA of cancer cells. Although
targeted therapy has been shown to produce
a dramatic response against cancer cells
without harming normal cells, this type of
treatment doesn’t always totally destroy the
cancer. Cancer cells have the ability to adapt
and develop alternative ways to grow, essentially becoming resistant to the treatment
over time. Tumors may shrink or disappear,
but remaining cells that are able to adapt may
begin growing again.
Immunotherapy is fundamentally different because it focuses on activating the
immune system to fight cancer, wherever
it may be, and uses the body’s own immune
cells and mechanisms to destroy the cancer.
HISTORY OF
IMMUNOTHERAPY
Immunotherapy is a cancer treatment more than 100 years in the making,
beginning most notably with Dr. William B. Coley, who worked with patients and multiple physicians to study how cancer tumors reacted to bacterial infections. He treated cancer patients with
inoperable tumors by injecting a combination of bacteria, which became known as Coley’s Toxins,
directly into their tumors. His results showed that this treatment shrank the tumors and sometimes
even cured the patient. He believed that the body’s increased response to the bacteria also helped
fight off the cancer.
In the modern era, Dr. Donald Morton was an early proponent of immunotherapy and particularly
cancer vaccines. His work with Bacillus Calmette-Guerin (BCG) for melanoma eventually led to the
use – and eventual approval – of BCG for bladder cancer, the first successful immunotherapy treatment against a human tumor.
Because the immune system can be activated broadly against cancer cells throughout
the body, it’s more difficult for cancer cells
to hide from therapy or develop mechanisms to escape destruction. Immunotherapy also has the potential to remain effective for long intervals far beyond the end of
treatment, a feature called “memory.” This
feature is the same one that allows a tetanus
vaccine, for example, to remain effective for
many years. In cancer patients, this effect
can lead to long-term, cancer-free remission
and increased overall survival. Because it’s
less likely that immunotherapy will affect
healthy tissues and cells, side effects may
be less common and either less severe or
more easily treatable. As with any treatment,
however, there are still associated risks that
should be discussed with your doctor (see
page 14).
Immunotherapy may be an option alone
or in combination with other treatments,
including traditional treatments and other
immunotherapies. Several different immunotherapy strategies are currently being
studied or used as cancer treatment:
n Monoclonal antibodies (mAbs) are engineered antibodies that target specific cancer
cell antigens (proteins on the surface of cancer cells) or receptors on the surface of immune cells.
n Non-specific immune stimulation involves giving the immune system a general
boost to improve overall function and response, without targeting the cancer cells
specifically.
n Cancer vaccinations are vaccines created
from either modified viruses or the patient’s
own tumor or immune cells and engineered
to direct immune cells to the cancer cells.
Oncolytic virus immunotherapy is the use
of viruses to directly infect only tumor cells
and induce an immune response against the
infected cancer.
n Immune-checkpoint inhibitors target the
immune checkpoints, which are a series of
immune system “brakes,” and disengage them
to make the immune response stronger.
n Adoptive T cell transfer (T cell therapy)
involves extracting immune cells from the
patient, activating them outside the body
using cancer tissues or T cell stimulants,
and then multiplying them in the lab before
injecting them back into the patient. n
3
9/17/2014 9:27:29 AM
THE IMMUNE SYSTEM and how it works
A
better understanding of how
the specific immunotherapy
strategies may work starts
with a basic knowledge of the
immune system and how it
interacts with cancer.
The immune system is the body’s natural defense against infection and disease,
responsible for protecting the host from
substances that can cause harm, such as
bacteria and viruses (sometimes called
“germs”). The cells of the immune system
continually circulate through the body,
monitoring for invaders. These invaders can be recognized by their “antigens,”
which are tiny proteins on their surface.
Every cell or substance has its own specific
antigens, and the body’s cells carry “self ”
antigens that are specific to that one person. Cells bearing self antigens typically
pose no threat. Invading germs, however,
carry “non-self ” antigens because they did
not originate in the body (see Figure 1).
The immune system is designed to recognize this kind of antigen as harmful and
respond appropriately.
The immune system and its responses
can be broken down into two subsystems:
innate immunity and adaptive immunity.
Innate immunity refers to the system that
finds the invaders and sounds the alarm.
Adaptive immunity refers to the system
that creates the battle plan and launches
the attack. Innate immune cells are responsible for gathering information about
the invader and sharing it with the cells
of the adaptive immune system. The innate immune system can also begin a very
general attack, but because the adaptive
immune system can’t “see” the threat until the innate cells share the information,
FIGURE 1
Invader
Self antigen
Immune cell
Non-self
antigen
©Patient Resource LLC
4
FIGURE 2
NORMAL IMMUNE RESPONSE
Immune cells
Antigen
Antigenpresenting
cells
Invader (bacteria)
Skinned knee:
First barrier of
protection is
broken.
An invader enters the body
through the cut, where
immune cells have begun to
gather to protect the body.
The immune cells begin
to destroy and digest the
invader and its antigens.
Some of the immune
cells transform into
antigen-presenting
cells that tell the
T cells about the
invader.
it’s important that they communicate as
soon as possible. This allows the adaptive
cells to start figuring out how to effectively
fight the specific invader.
Most immune cells release messengers
called cytokines to help them communicate with other immune cells and regulate
the immune system response.
has been identified, B cells will work rapidly
to produce antibodies against the invading
germs, which can eliminate bacteria. Viruses like to hide inside normal cells and may
be difficult for the immune system to “see,”
but T cells are designed to detect abnormal
Attacking a normal enemy
Antigen-presenting cell (APC)
When you skin your knee, you break the
immune system’s first barrier, the skin, and
harmful substances can easily enter the body
(see Figure 2). Luckily, as soon as the injury
occurs, immune cells that have been circulating in your body start to gather at the site
and call other immune cells to help defend
the body against invasion. Any bacteria or
foreign substance that enters should be recognized by the immune cells as an invader.
Innate immune cells known as natural killer
cells begin to destroy the invaders with a
general attack. Although this attack can kill
some, it may not be able to destroy all of
them or may be unable to prevent them from
multiplying. Meanwhile, other immune cells
start to eat the invaders and their foreign antigens. This “eating” causes the immune cells
to transform into antigen-presenting cells
(APCs). The APCs continue to gather information, which they then present to the primary immune cells of the adaptive immune
system – the B and T cells. Once an antigen
FIGURE 3
Antigen
Naïve
(inactive)
T cell
MHC
T cell
receptor
Antigen-presenting cell presents antigen to naïve
T cell, known as Signal 1.
Antigen-presenting cell (APC)
Antigen
Activated
T cell
T cell receptor
MHC
Co-stimulatory
molecules
T cell recieves co-stimulatory signal to fully
activate, known as Signal 2.
9/17/2014 9:27:35 AM
fragments inside normal cells. Before these
T cells have been told what to attack, they’re
known as “naïve” T cells.
In order for the APCs to effectively communicate with and activate the naïve T cells,
they must connect through protein molecules on their surfaces. A specific molecule
on the APC, called the Major Histocompatibility Complex (MHC) molecule, must successfully connect to the receptor on the T
cell (see Figure 3). This first interaction is
sometimes referred to as Signal 1. This connection allows the T cell to finally “see” the
antigen and recognize it as a threat. Before
a T cell can become fully activated, however, a second connection between additional
molecules is necessary to confirm that the T
cell still needs to launch an attack against the
invader. This second signal is known as the
co-stimulatory signal, or Signal 2. If a T cell
receives Signal 1 but not Signal 2, it will die,
ending the possibility of attacking the threat.
If the T cell receives both signals, it will now
be able to recognize the invader and destroy
it. This fully activated T cell then multiplies
to develop an army of T cells equipped with
the necessary mechanisms to recognize and
destroy the threat (see Figure 4).
After multiple generations of immune
cells have been created by the same immune response, some T cells transform
into “regulatory” T cells, which are responsible for slowing and eventually
shutting down the immune response
FIGURE 5
Tumor
cell
FIGURE 4
T CELL PROLIFERATION
Activated T cells
When a T cell receives both signals to fully activate, the cell multiplies.
once the threat has been eliminated. Other T cells may become “memory” T cells,
which can stay alive for many months or
even years to fight off the same invader.
This is the basis of immune protection
against disease and explains why we don’t
get the same diseases twice, such as measles or chicken pox.
Because cancer cells
are created by the body,
the normal methods
used to find and fight
foreign invaders are
not always effective.
Attacking cancer
Because cancer cells are created by the
body, the normal methods used to find
and fight foreign invaders are not always
effective. If the body can’t distinguish the
tumor cells from normal cells, the tumor
cells may go completely unrecognized.
However, a major feature of cancer cells
is changes in their DNA, which can lead
to abnormal proteins that are not found
in normal, noncancerous cells. These abnormal proteins can often be recognized
by the immune system much like the immune system can recognize viral proteins
in normal cells. Because the T cells are responsible for eliminating most viral infections, they have been the primary focus of
recent research.
If the immune system detects cancer,
the APCs must share that information
with the T cells (see Figure 5). T cells are
HOW THE IMMUNE SYSTEM ATTACKS CANCER
Tumor
antigens
APC
Naïve T cell
Activated T cell
Activated
T cell
Destroyed
tumor cell
Tumor
cell
Tumor cells release
tumor antigens.
APCs gather tumor
antigens and prepare to
present to naïve T cells.
T cells are
activated by
the APC.
Activated T cells find the tumor
cells with the same tumor
antigens and destroy them.
5
9/17/2014 9:27:39 AM
THE IMMUNE SYSTEM
the primary players in the fight against
cancer and their ability to activate and attack cancer is at the heart of immunotherapy research. These cells communicate
with each other through a network of cell
signaling. When the molecules on an APC
connect to receptors on the T cell, the result is either a positive signal or a negative signal. Positive signals tell the T cell to
activate and multiply. Negative signals tell
the T cell to shut down. A T cell can only
function properly if it recognizes the cancer as harmful, receives the proper signals
to fully activate, and then gets continued
approval to launch and maintain an attack.
The delicate balance of these positive
and negative signals regulates the strength
and duration of the immune attack, keeping the attack going until the threat has
been eliminated, then helping to shut it
down once it’s no longer necessary (see
Figure 6). However, cancer cells are able
to take control of this normal mechanism
that the body uses to shut off the immune
response. This means that even if the immune system recognizes the cancer, it may
not be able to successfully start the attack
or maintain it long enough to eliminate
the threat.
One specific area of research focuses on
the cancer cells’ ability to trick the immune
FIGURE 6
APC
T cell
MHC
T cell receptor
Tumor antigen
+
+
+
Co-stimulatory molecules
The positive and negative signals help to regulate
the strength and duration of the immune response.
system into prematurely engaging “checkpoint pathways.” Checkpoint pathways are
part of the system of checks and balances
that allow the immune cells to evaluate
their attack at multiple stages; pathways
THE 3 E’s
1
CANCER
vs. THE BODY 2
essentially function as the brakes when
the response is no longer necessary. By engaging the brakes, the cancer shuts down
the attack response and is able to continue
growing. Recent research has shown that
Elimination – In the elimination phase, the immune system recognizes
and eliminates cancer cells. This phase suggests that our bodies may be
regularly introduced to cancerous changes and that our immune systems are
capable of handling and eliminating them.
In the 1950s, researchers thought the immune sys-
tem did two things: it protected your body against bacteria and viruses, and it looked for abnormal cells and
killed them before they could become tumors. Called
the cancer immunosurveillance theory, it was initially
rejected. In the last 10 years, however, studies have
shown that immune cells are indeed important in the
prevention of cancer. Although tumors may develop in
a functioning immune system, the way a tumor grows
and develops is influenced by the body’s immune
response. Based on this new evidence, the theory has
been refined and renamed “cancer immunoediting”
and confirmed by the mouse tumor studies conducted
by Dr. Robert Schreiber.
The three E’s of Dr. Schreiber’s theory of cancer immunoediting are elimination, equilibrium and escape:
6
Equilibrium – If the cancer cells are not eliminated immediately, they
may exist in a delicate balance between growth and suppression by the
immune system. During equilibrium, the body’s immune system is able to keep
the cancer cells under control but is unable to eradicate them completely. In
this phase, a tumor may remain dormant for an indeterminate amount of time,
completely unrecognized by medical testing. According to the theory, however,
the constant interactions between the tumor cells and the T cells of the adaptive immune system may actually lead to tumors that can adapt to the immune
response and are no longer susceptible to an immune attack. Tumors that have
successfully adapted to the immune response can no longer be controlled and
move on to the third phase.
3 Escape
– The escape phase refers to the disruption of equilibrium (balance) that leads to immunosuppression, allowing the dormant tumors to
escape immune control and begin growing in an environment of immune “tolerance.” It’s at this point that the clinical symptoms of cancer begin to emerge.
Tumors in the escape phase use a number of mechanisms that alter the body’s
immune response in such a way that actually allows them to grow.
9/17/2014 9:27:42 AM
TOLERATING CANCER
HOW CANCER CELLS EVADE DETECTION
If you suffer from an allergy – pollen, for example – you might
see your doctor for periodic allergy shots. These shots work much
like a vaccine: As the amount of the particular allergen is injected in
increasing doses over a series of visits, your body begins to develop
a tolerance to pollen. This type of therapy can eventually lead to
decreased symptoms from a pollen exposure, or even may eliminate your symptoms altogether. Because your body no longer recognizes pollen as an invader, the immune system stops attacking it.
blocking the effect of these checkpoint
pathways can restore the activity of tumor-directed immune cells. Recent breakthroughs in immunotherapy research
have involved two checkpoint pathways,
the CTLA-4 immune checkpoint pathway
and the PD-1/PD-L1 immune checkpoint
pathway (see Figure 7).
FIGURE 7
Cancer often uses this same trick. In early stages, cancer cells
may shed proteins into your body. As these proteins circulate
through your bloodstream, you begin to develop a tolerance. And
once that tolerance exists, your body may not recognize these
cancer cells as a threat. Then, just like the pollen, the cancer
cells may be safe from an immune system attack.
Immunotherapy seeks to reverse this tolerance, to once again
identify the cancer cells as a threat and a target for destruction.
CHECKPOINT PATHWAYS
APC
MHC
T cell receptor
+
The delicate
balance of these
positive and
negative signals
regulates the
strength and
duration of the
immune attack.
+
-
CTLA-4
CTLA-4
checkpoint
pathway
When the CTLA-4 molecule connects instead of other
molecules, a negative signal is sent to the T-cell.
T cell
Tumor cell
Tumor antigen
MHC
The longer the exposure to the tumor,
the more reduced the immune response becomes. And the longer cancer cells are subjected to a weakened immune response, the
more they’re able to adapt, and the easier
it is to manipulate immune cells. It’s as if
the tumor recruits the body’s own immune
cells to turn around and fight off the attack,
using the very mechanisms put in place
for protection. Immunotherapy research
focuses on finding these different ways
tumors manipulate the immune system to
reduce its effectiveness, with the goal of allowing the immune system to react to the
cancer for as long as necessary to destroy
all of the tumor cells. n
T cell
Tumor antigen
T cell receptor
+
PD-L1
PD-1
PD-1
checkpoint
pathway
When PD-1 connects to PD-L1, a negative
signal is sent to the T cell to inactivate.
7
9/17/2014 9:27:46 AM
TYPES OF IMMUNOTHERAPY
C
ancer immunotherapy targets
the different stages of the anticancer immune response that
appear to be easily influenced
and manipulated by tumors.
Several immunotherapy strategies have been
created to help stimulate and re-engage the
immune system, including treatments to
help the immune cells recognize and destroy
cancer cells.
by strategy
FIGURE 2
DELIVERING THERAPEUTIC AGENTS TO
CANCER CELLS WITH MONOCLONAL ANTIBODIES
Chemotherapy drug
Monoclonal antibody (mAb)
FIGURE 1
Monoclonal antibody
A monoclonal antibody (mAb) carrying
chemotherapy targets specific cancer
cells and attaches to the surface.
The tumor cell engulfs the mAb.
Monoclonal antibody with
attached therapeutic agent
Monoclonal antibodies (mAbs)
One of the body’s natural immune responses
to foreign substances is the creation of antibodies specific to the antigens found on the
surface of invaders and damaged or infected
cells. Monoclonal antibodies are manmade
antibodies engineered to target specific tumor
antigens. They work in a few different ways:
nFlagging targeted cancer cells for destruction – The mAb can act as a flag that
attaches to molecules or parts found only on
the surface of specific cancer cells, marking
them for destruction by other immune cells.
nBlocking growth signals and receptors –
Some mAbs are engineered to block the mechanisms that cancer cells use to grow. These
mAbs work in a variety of ways, including
blocking certain pathways that allow the cancer to thrive, or destroying the blood supply
for the tumor. Cancer cells rely on these blood
vessels to deliver oxygen and nutrients; blocking them deprives the cancer cell of resources,
which can help to slow or stop growth.
As the mAb is digested, the toxic particles are released,
causing cell death from within.
nDelivering
other therapeutic agents directly to targeted cancer cells – The mAbs
can be engineered to carry cancer drugs or
radiation particles directly to cancer cells.
When a mAb is combined with a chemotherapy drug or specific toxin, it travels through
the system until it reaches the targeted cancer cell, then attaches to its surface. The tumor cell then engulfs the mAb and begins
to break it down internally. This releases the
chemotherapy drug or toxin, inducing cell
death from within. Basically, the tumor cell
inadvertently causes its own death. This di-
>> TIMELINE OF IMMUNOTHERAPY
1890 Dr. Coley
creates the first
immunotherapy treatment when he injects
bacteria directly into
inoperable tumors to
stimulate an immune
response that also
fights the cancer.
8
1956 Tumor-specific
cell antigens are
discovered.
1973 Dendritic
cells are identified as
“antigen-presenting
cells” (APCs).
1978 Bacillus
Calmette-Guerin is first
studied for bladder
cancer; interleukin-2
(IL-2) is discovered.
1978 Tumor-specific
monoclonal antibodies
(mAbs) are discovered.
1984 Society for
Immunotherapy of
Cancer (formerly SBT)
is founded.
1985 Adoptive T cell
transfers are studied
as a possible cancer
treatment.
rect form of delivery typically damages only
the targeted cells.
Combining mAbs with radiation particles,
called radioimmunotherapy, allows for radiation to be delivered in lower doses over a longer period of time directly to specific cancer
cells, leaving the majority of surrounding cells
undamaged. These radiation-tagged mAbs
may also be helpful in determining the diagnosis or spread of certain cancers by using
a special imaging device to detect where the
radioactive particles accumulate in the body.
1985 Results from
IL-2 and lymphokineactivated killer cell
(LAK) cell therapy in
various tumors are first
reported.
1986 The Extramural
IL-2/LAK Working
Group is formed with
funding from the National Cancer Institute
to confirm results of
the high-dose IL-2/
LAK cell regimen in the
treatment of melanoma
and renal cell cancer.
9/17/2014 9:27:49 AM
Chemical messengers called cytokines
can also be attached to a mAb, which is then
called an immunocytokine. This agent delivers cytokines to the tumor cells to help promote a normal immune response. This therapy is being tested in clinical trials right now.
A number of monoclonal antibodies are
currently available to treat several different
cancers, and clinical trials are currently testing new ones for nearly every type of cancer.
Approved monoclonal antibodies include:
• Breast cancer: trastuzumab (Herceptin),
ado-trastuzumab (Kadcyla)
• Chronic lymphocytic leukemia:
obinutuzumab (Gazyva), alemtuzumab
(Campath), rituximab (Rituxan),
ofatumumab (Arzerra)
• Colorectal cancer: bevacizumab (Avastin), cetuximab (Erbitux), panitumumab
(Vectibix)
• Gastric cancer: trastuzumab (Herceptin),
ramucirumab (Cyramza)
• Hodgkin lymphoma: brentuximab
vedotin (Adcetris)
• Kidney cancer: bevacizumab (Avastin)
• Lung cancer: bevacizumab (Avastin)
• Melanoma: ipilimumab (Yervoy),
pembrolizumab (Keytruda)
• Non-Hodgkin lymphoma: rituximab
(Rituxan), ibritumomab (Zevalin)
Notable mAbs in clinical trials include:
• bavituximab (breast cancer, liver cancer,
lung cancer, melanoma, pancreatic
cancer, rectal cancer)
• blinatumomab (ALL, non-Hodgkin lymphoma, gastric cancer, lung cancer)
• Ch14.18 (neuroblastoma)
• MT110 (colorectal cancer, gastric cancer,
lung cancer)
• nivolumab (melanoma)
• rilotumumab (fallopian cancer, gastric
cancer, lung cancer, ovarian cancer)
• selectikine (melanoma)
1988 First results
from tumor-infiltrating
lymphocytes (TIL)
therapy are reported.
1990 Bacillus
Calmette-Guerin is
approved for treatment
of bladder cancer.
1990 First treatment
with genetically modified TIL.
1991 Granulocyte
macrophage-colony
stimulating factor (GMCSF), sargramostim
FIGURE 3
APC
FIGURE 4
MHC
Tumor T cell receptor
antigen
T cell
T cell
T cell receptor
Tumor cell
MHC
Tumor
antigen
PD-1
CTLA-4
APC
MHC
Tumor
antigen
T cell receptor
PD-L1
T cell
Monoclonal antibody
blocking the connection
Immune checkpoint inhibitors
Immune checkpoint pathways are the specific connections between molecules on
the surfaces of cells – specifically between
antigen-presenting cells and T cells, or between T cells and tumor cells – that help
regulate the immune response. Some tumor
cells have proteins on their surface that bind
to activated immune cells, inhibiting their
function. This connection effectively puts
the brakes on the attack (known as tumorinduced immunosuppression).
Understanding how to block certain immune checkpoint pathways is an important
focus of current research. Immune checkpoint inhibitors are drugs that block the
checkpoint from being engaged, which essentially turns the immune response back
(Leukine), is approved
to boost white blood
cell counts.
1992 High-dose IL-2
is approved to treat
metastatic kidney
cancer.
T cell receptor
Tumor
antigen
CTLA-4
CTLA-4
checkpoint
pathway
T cell
PD-1
MHC
Tumor cell
PD-L1
Monoclonal antibody
PD-1
checkpoint blocking the connection
pathway
on. Immune checkpoint inhibitors currently
being studied for use in the treatment against
cancer include:
nAnti-CTLA-4: CTLA-4 is a protein receptor
found on the surface of T cells. When engaged
by molecules on the surface of antigen-presenting cells, CTLA-4 is capable of suppressing the immune system response (known as
“downregulating”). Anti-CTLA-4 antibodies
block the connection necessary to engage this
protein, allowing the T cells to continue their
response against the cancer cells, rather than
shutting it down (see Figure 3).
nAnti-PD-1: The PD-1 checkpoint pathway is CTLA-4’s checkpoint pathway backup.
When the PD-1 receptors on the surface of T
cells connect with the PD-L1 molecules on the
surface of cancer cells, signals are sent to the T
1996 Interferon alfa2b is approved for the
adjuvant treatment of
high-risk melanoma.
cell malignancies.
1998 IL-2 is approved to treat metastatic melanoma.
1997 The first
monoclonal antibody,
rituximab (Rituxan), is
approved to treat B-
1998 The monoclonal antibody drug
trastuzumab (Herceptin) is approved to
treat breast cancer.
1999 Denileukin diftitox (Ontak), a fusion
of IL-2 and diphtheria
toxin, is approved.
>>
2000 Gemtuzumab
ozogamicin (Mylotarg),
which combines a
9
9/17/2014 9:27:53 AM
cells to dampen the response. Anti-PD-1 drugs
block the connection necessary to engage this
protein, allowing the T cells to continue their
response against the cancer cells.
nAnti-PD-L1: Cancer cells have the ability to make certain molecules appear on the
surface, including PD-L1 and PD-L2 of the
PD-1 checkpoint pathway. These molecules
bind to the PD-1 on the T cells and turn
them off, preventing attack of the cancer cell.
In addition to researching PD-1 inhibitors,
scientists are also researching blocking the
PD-L1 molecule (see Figure 4, page 9).
These checkpoint pathway blockers stop
the negative signals associated with certain
checkpoint pathways, but researchers are
also studying ways to increase the positive
signals between cells that can promote stronger immune responses. For example, studies
have shown that engaging certain stimulatory receptors with the use of monoclonal
antibodies enhances the number and activity
of certain T cells. This increases the amount
of positive signals and decreases the impact
of the negative signals. Clinical trials are also
studying the use of both types of treatment at
the same time.
FDA-approved immune checkpoint inhibitors include:
• Melanoma: ipilimumab (Yervoy),
pembrolizumab (Keytruda)
Notable immune checkpoint inhibitors in
clinical trials include:
• ipilimumab (Yervoy) (non-small cell lung
cancer, prostate cancer)
• MPDL-3280A (advanced melanoma, lung
cancer, kidney cancer, bladder cancer)
• nivolumab (advanced melanoma, lung
cancer, kidney cancer, head and neck
cancer)
• pembrolizumab (MK-3475) (lung cancer,
kidney cancer, head and neck cancer)
>>
>>
TABLE 1
IMMUNOTHERAPY TREATMENTS BY CANCER TYPE
Cancer
FDA-approved treatments
Major clinical trials
Bladder
• Bacillus Calmette-Guerin
• MPDL-3280A
Blood cancers
• alemtuzumab (Campath)
• brentuximab vedotin (Adcetris)
• ibritumomab (Zevalin)
• interferon alfa-2a (Roferon-A)
• obinutuzumab (Gazyva)
• ofatumumab (Arzerra)
• rituximab (Rituxan)
• Adoptive T cell therapy
• Anti-PD-1/PD-L1 treatments
• BioVaxID
• blinatumomab
• Chimeric antigen receptors (CARs)
Breast cancer
• ado-trastuzumab emtansine
(Kadcyla)
• trastuzumab (Herceptin)
• bavituximab
• NeuVax
Kidney cancer
• bevacizumab (Avastin)
• High-dose interleukin-2
• IFN-alfa
• Combination treatments (ipilimumab/nivolumab)
• MPDL-3280A
• nivolumab
Lung cancer
(NSCLC)
• bevacizumab (Avastin)
• bavituximab
• blinatumomab
• ipilimumab (Yervoy)
• MPDL-3280A
• MT110
Melanoma
• High-dose interleukin-2
• High-dose interferon alfa
• ipilimumab (Yervoy)
• pegylated interferon alfa-2b
• pembrolizumab (Keytruda)
• Adoptive T cell therapy
• bavituximab
• Combination treatments (ipilimumab/nivolumab)
• nivolumab
• selectikine
• talimogene laherparepvec (TVEC)
Prostate cancer
• sipuleucel-T (PROVENGE)
• sipuleucel-T/Pca combination treatments
• Toll-like receptor (TLR) ligands (adjuvant therapy)
• tremelimumab (hepatocellular cancer,
mesothelioma)
• Combination ipilimumab/nivolumab
(advanced melanoma, kidney cancer,
non-small cell lung cancer)
Non-specific immune stimulation
Non-specific immune stimulation involves
giving the immune system an overall boost.
This is achieved by exposing the body to certain molecules capable of activating immune
cells, such as T cells, resulting in an increased
immune response. This type can be used
alone or in combination with other treatments in order to produce increased and longer lasting immune responses. Different types
of non-specific immune stimulation include:
• nivolumab
• pembrolizumab
(MK-3475)
• rilotumumab
immunotherapy – Cytokines are
the messengers of the immune system, aiding in communication between immune
cells and playing a big role in the full activation of an adaptive immune response. Cytokine immunotherapy treatments involve introducing large amounts of cytokines to the
immune system to promote specific immune
responses. There are several cytokines currently being studied in the treatment against
cancer, including interleukin, interferon and
GM-CSF:
• Interleukins are cytokines that help regulate the activation of certain immune cells.
These proteins have been successfully recreated in a lab and developed into the drug
IL-2. There are also several molecules siminCytokine
TIMELINE OF IMMUNOTHERAPY
monoclonal antibody
and a toxin from the
bacteria Micromonospora echinospora,
is approved for acute
myeloid leukemia.
2002 Ibritumomab
tiuxetan (Zevalin), a
10
monoclonal antibody
with a radioisotope, is
approved for some nonHodgkin lymphomas.
2003 Tositumomab
and Iodine I 131 tositumomab (Bexxar), a
monoclonal antibody-
based, radioimmunotherapeutic regimen
for the treatment of
CD-20 positive, follicular non-Hodgkin lymphoma, is approved.
2004 Monoclonal
anti-vascular endo-
thelial growth factor
antibody bevacizumab
(Avastin) is approved
for metastatic colorectal cancer.
2004 Cetuximab
(Erbitux), an antiepidermal growth
factor receptor
monoclonal antibody,
is approved.
2006 Panitumumab
(Vectibix), a monoclonal anti-epidermal
growth factor receptor
antibody, is approved.
2009 Anti-CD20
monoclonal antibody
ofatumumab (Arzerra)
is approved for chronic
lymphocytic leukemia.
2010 Gemtuzumab
ozogamicin is discontinued due to safety
9/17/2014 9:27:53 AM
FIGURE 5
lar to IL-2 in clinical development, including IL-7, IL-12, IL-15 and IL-21.
• Interferons are cytokines that boost the
ability of certain immune cells to attack
cancer cells. These proteins have been successfully re-created in a lab and developed
into the drug IFN-alfa.
• GM-CSF (granulocyte-macrophage colony stimulating factor) are cytokines that
stimulate the bone marrow, promoting immune and blood cell growth and dendritic
cell development. GM-CSF has been successfully re-created in a lab, developed into
the drug sargramostim (Leukine) and is
currently being used to boost white blood
cell count after chemotherapy treatment.
Some studies have suggested a benefit with
sargramostim alone or in combination
with other immunotherapy agents for patients with advanced melanoma, but this
has not yet been confirmed in randomized
clinical trials.
bacteria – One approved treatment for bladder cancer is actually an altered tuberculosis vaccine called intravesical Bacillus Calmette-Guerin (BCG). BCG
is bacteria that have been modified to ensure they will not spread disease. Treatment
causes inflammation in the bladder that
guides the immune response to the bladder
cancer cells.
nToll-like receptor agonists – The immune
system often detects germs through a series
of receptors called toll-like receptors that are
found on the surface of most immune cells.
When patterns in bacteria or viruses are
“seen” by these toll-like receptors, they produce a signal that activates the immune cell to
attack. Several of these specialized receptors
have been evaluated for use in cancer, and
one such agent, imiquimod (Aldara, Zyclara),
binds to the toll-like receptors 7 and 8, resulting in an immune response that kills cancer
nModified
concerns and lack of
benefit.
advanced prostate
cancer.
2010 The first
therapeutic cancer
vaccine, sipuleucel-T
(PROVENGE), a dendritic cell vaccination,
is approved to treat
2011 Ipilimumab
(Yervoy), a monoclonal
antibody targeted to
a T cell checkpoint
protein, is approved to
treat melanoma.
DENDRITIC (or APC) CELL VACCINES
4
The APCs are injected back into
the patient, where they activate
T cells so they can find and fight
the cancer cells.
Antigen-presenting cells
3
This transforms
them into APCs.
1
The patient’s own
immune cells are
extracted from
the body.
Immune cells
2
These cells are sent to a lab.
cells in patients with basal cell skin cancers
and possibly other early-stage skin cancers.
Current FDA-approved non-specific immune stimulators include:
• IFN-alfa (kidney cancer, melanoma, certain leukemias and lymphomas, Kaposi
sarcoma)
• IL-2 (kidney cancer, melanoma)
• Bacillus Calmette-Guerin (bladder cancer)
• imiquimod (Aldara, Zyclara) (early-stage
skin cancer)
Notable non-specific immune stimulators
in clinical trials include:
• montanide (used concurrently with
cancer vaccinations in the treatment of
several cancers)
• Toll-like receptor (TLR) ligands as
adjuvant therapy with therapeutic cancer
vaccines (brain, kidney, lung, colon, pancreatic, prostate, ovarian, breast)
• sargramostim (Leukine) used as adjuvant
2011 Pegylated interferon (PEG-Intron) is
approved for adjuvant
therapy of selected
melanoma patients.
2012 Several clinical studies of T cell
checkpoint inhibitors
targeting PD-1 and
PD-L1 demonstrate
therapeutic activity in
many types of cancer.
2013 The combination of two agents
targeting CTLA-4 and
PD-1 checkpoints
therapy with therapeutic cancer vaccinations (prostate and pancreatic cancer)
Cancer vaccines
There are two types of cancer vaccines: prophylactic vaccines used to prevent the viruses
that cause cancers and therapeutic vaccines
used to treat existing cancers. Currently,
prophylactic vaccinations are available for
the human papillomavirus (HPV), the cause
of most cervical cancers, and hepatitis B
(HBV), a known risk factor for liver cancer.
Therapeutic cancer vaccinations include
several types:
nTumor cell vaccines (autologous) – Autologous tumor cell vaccinations are made
from your own tumor cells, extracted directly from the tumor or from the blood and
treated with radiation to prevent spreading.
This allows each patient to have a customized
vaccine that includes antigens from the patient’s own cancer cells. They are modified in
a lab to make them safer and more susceptible
demonstrate remarkable activity in a
melanoma clinical trial.
2013 The first Phase
III trial of oncolytic
virus immunotherapy
shows improvement in
the long-term response
rate in patients with
melanoma.
2014 Pembrolizumab
(Keytruda) is the first
PD-1 inhibitor to gain
FDA approval to treat
advanced melanoma.
11
9/17/2014 9:27:55 AM
to immune attack, then injected back into the
body. Allogeneic tumor cell vaccinations are
another option; the cells or tissues used to
make the vaccination come from a donor.
This method is typically easier and less expensive, but a difference in effectiveness between the two has not yet been determined.
nAntigen (or peptide) vaccines – These are
made from the proteins or pieces of proteins
(peptides) expressed on only the surface of
tumor cells rather than the entire cancer cell.
These vaccinations are specific to a certain
type of cancer but are not patient-specific.
nDendritic (or APC) cell vaccines – Dendritic cell vaccinations are made from white
blood cells that are extracted from the patient
and sent to a lab, where they are exposed to
chemicals that turn them into dendritic cells.
These dendritic cells are then exposed to
cancer cells and tumor antigens so that they
begin preparing the antigen material for presentation before being injected back into the
body (see Figure 5, page 11). These matured
APCs activate the T cells in the body with the
tumor antigens they need to recognize the abnormal cancer cells as a threat. Any cells that
release that specific antigen are then targeted
and destroyed. Sipuleucel-T (PROVENGE) is
an FDA-approved drug consisting of chemically activated dendritic cells exposed to the
prostate cancer antigen expressed by most
prostate cancer cells as well as the cytokine
GM-CSF. These matured APCs are injected
into the body to help train the immune system
to recognize and destroy the cancer cells that
express that antigen.
nVector-based vaccines – Vector-based
vaccines are made from altered viruses or
bacteria that are injected into the body to
create an immune response, both specific
FIGURE 6
12
>>
Oncolytic virus immunotherapy uses natural or modified viruses to directly attack and
kill tumor cells while simultaneously starting
an immune response. One of the most-studied
approaches uses a modified, weakened version
of the herpes simplex virus called talimogene
laherparepvec (TVEC). TVEC is a safer herpes virus that contains the gene for GM-CSF.
The virus targets only specific cancer cells, infects them and replicates continuously within
the cell until it explodes (see Figure 6). This
kills the cell and releases the GM-CSF protein
implanted with the virus to promote an overall
immune system boost against the cancer. The
immune response can then eliminate cancer
cells that have not been infected with the virus.
FDA approved cancer vaccinations include:
• Cervarix (cervical-cancer-causing HPV)
• Gardasil (cervical-cancer-causing HPV)
• Hepatitis B vaccine (liver cancer risk
factor hepatitis B)
• sipuleucel-T (PROVENGE) (prostate
cancer) – dendritic cell vaccination
(DCVac)
Notable cancer vaccinations in clinical
trials include:
• BioVaxID (non-Hodgkin lymphoma and
mantle cell lymphoma)
• CDX-110 (brain cancer)
• CRS-207 and GVAX Pancreas
combination (pancreatic cancer)
•
•
•
•
•
•
DCVax (brain cancer)
GVAX Pancreas (pancreatic cancer)
HyperAcute-Pancreas (pancreatic cancer)
Imprime PGG (colorectal cancer)
NeuVax (breast cancer)
sipuleucel-T (PROVENGE) (in combination with other treatments)
• TVEC (metastatic melanoma)
Adoptive T cell transfer
Adoptive T cell transfer focuses on manipulating the body’s own T cells to fight cancer. Immune cells are collected from the patient, engineered to recognize specific cancer cells, and
then infused back into the patient. The modified T cells seek and destroy the cancer cells
that carry those specific antigens. The three
methods of adoptive T cell transfer include:
• Collecting a sample from the actual
tumor and multiplying the tumorinfiltrating T cells in a laboratory
• Taking T cells from the bloodstream and
genetically altering them to attack cancer
cells that have specific antigens
• Taking T cells from the body and modifying them with special receptors, called
chimeric antigen receptors (CARs), that
recognize specific proteins found on the
surface of cancer cells. The CAR T cells
bind to the cancer cells that have those
proteins and then destroy them.
This type of immunotherapy treatment
is still investigational and available only
through clinical trials. Studies have shown
promise in the treatment of leukemia, lymphoma, metastatic melanoma, neuroblastoma and synovial cell sarcoma. n
ONCOLYTIC VIRUS IMMUNOTHERAPY
Engineered oncolytic viruses
find specific cancer cells...
and overall. Tumor-specific vectors are genetically modified to target specific cancer
cells in such a way that trains the immune
system to recognize and destroy them. One
vector-based vaccine currently being studied
to treat leukemia is an HIV virus (modified
to no longer cause disease).
...infect them and begin
to multiply inside.
The viruses continue
to multiply....
...until the cancer cell ruptures,
releasing cancer-fighting viruses
and immune-stimulating antigens.
9/17/2014 9:28:03 AM
SURVIVOR STORY Steven Silverstein
Survivor Dedicated Himself to Giving
Back After Melanoma
Steven Silverstein is a 58-year-old Stage IV melanoma survivor. His
disease was initially dismissed, but after his eventual diagnosis and a
few different treatment options, he was given an immunotherapy drug
that saved his life. Steven spent 34 years working in the lighting industry, but in 2013, he sold his company and began devoting his time to the
Melanoma Research Foundation, the Department of Defense Cancer
Funding Program, The Valley Hospital and other organizations. Steven
and his wife, Ava, have been married for 30 years and have two daughters and a dog. When he can find the time, Steven enjoys photography,
cycling, skiing and golf.
T
here has been no moment in my life more horri-
ble than the moment I was confronted with a cancer
diagnosis. The instant in which I learned I had Stage
IV melanoma will stick with me forever; however,
I’ve since moved past the disease both physically
and emotionally.
Let’s first jump back to the beginning. My story began about
11 years ago during a routine visit to the dermatologist when I
pointed out a lesion on my face. The doctor said it was nothing,
but he arranged to have a plastic surgeon remove it anyway upon
my request. The plastic surgeon confirmed it was nothing and
decided it wasn’t even worth sending to the lab for testing.
The following summer, I developed some swelling under my
jaw. A needle biopsy revealed melanoma, and a full-body scan
uncovered liver metastasis. Because my cancer had initially gone
undiagnosed, it had already progressed into Stage IV disease.
The news of my diagnosis left me shocked, devastated and
overwhelmed. I had always been a proactive, sun-educated individual who visited the dermatologist annually. I was at a wonderful stage of family life, and I had just returned from a weeklong
trip full of hiking and rock climbing only to be told I had just 12 to
18 months to live.
I met with several oncologists to get multiple opinions. I also
developed an inner team of personal advisers, which consisted
of several knowledgeable family members and friends. They
helped me reflect upon and analyze the massive amounts of information I was receiving from medical professionals.
Ultimately, I opted for a full neck dissection to remove the cancer from my lymph nodes. Even though the doctors and I knew it
wouldn’t cure my disease due to the liver metastasis, we wanted
to remove as much of the tumor load as possible. Following surgery, I unsuccessfully attempted to join a clinical trial, so I instead
started a chemotherapy regimen that included the drugs temozolomide (Temodar) and thalidomide (Thalomid). I also tried chemoembolization to attempt to slow the cancer growth; a catheter
was inserted into my liver and drugs blasted specific sites.
In addition to the traditional treatments, I also started acupuncture, began eating an organic diet, got plenty of exercise and rest,
and enlisted the services of a psychiatrist.
As time went on and no treatment had proved effective, it became clear that I was nearing the end of my options. We decided
it was time to try interleukin-2 (IL-2) despite its notorious side effects, which can include flu-like symptoms, nausea, skin sensitivity, kidney reactions, digestive tract inflammation and more. Was
it fun? Hardly. But it wasn’t as bad as its reputation, and in the
hands of an experienced team, led by Dr. Howard Kaufman, all of
these symptoms were manageable. Additionally, the chance of
being cured was well worth the discomfort.
About five months after starting IL-2, the progress of my disease had stopped and there was no further evidence of active
metabolic activity. I was thrilled, but I wanted to be vigilant about
staving off recurrence, so I followed up that treatment with a
three-year regimen of injections with the then-experimental drug
sargramostim (Leukine). I also had follow-up PET and CT scans
every three months for five years and every six months thereafter, ceasing by the end of the eighth year.
These days, I’m doing great. I’m approaching my 11th anniversary of being cancer-free, and I’m fortunate to have no lasting
physical effects. All that’s left is a new awareness and a calling to
give back to the cancer community. A while back, I began to get
involved with the Melanoma Research Foundation (MRF), and
soon I was on the board, learning about and gaining insights into
the world of cancer research.
All those years ago when I was lying in a hospital bed, fighting
and hoping for the best, I was overwhelmed with questions like,
“How are drugs and cures developed?” and “Why does it take
so long?” Now, as chair of MRF, I understand the answers to
those questions, and I do what I can to share my knowledge with
those currently engaged in their own battles. I also discuss with
them the treatment process, the breaking news and trends in the
field, where to get help, and other important issues surrounding
family, friends, physical condition and mental attitude. My hope
is that they take comfort in knowing there’s an entire community
dedicated to supporting their needs and eradicating melanoma. n
13
9/17/2014 9:28:05 AM
TALKING WITH YOUR DOCTOR about immunotherapy
B
e sure to discuss the prospect of
immunotherapy with your doctor to see if it’s the best treatment option for your particular
diagnosis, or if there’s any added
benefit to including immunotherapy as a part
of your comprehensive cancer care. Below are
some topics you should discuss and information to help you begin the conversation. Also
included are other suggested questions you
may want to ask if you’re considering immunotherapy as a treatment:
What makes immunotherapy so different?
Immunotherapy activates your body’s
own immune cells to find and attack cancer
cells. Every day the immune system fights
off viruses and infections, but because cancer is so similar to normal cells, the immune
system’s typical response may not work. Different types of immunotherapy trigger the
body’s immune system in different ways to
find and destroy the cancer.
>>
Is it like chemotherapy?
No. Immunotherapy is a completely different method of treatment. Unlike chemotherapy, which uses powerful drugs to kill
rapidly multiplying cells, immunotherapy
focuses on re-engaging the immune system
so that it recognizes and kills only specific
cancer cells.
>>
What are the possible side effects?
With immunotherapy, cancer cells are
targeted and destroyed by the body’s own
immune system rather than by drugs or radiation. Because of this, damage to healthy
tissue is often less than with other therapies.
This means immunotherapy doesn’t normally
cause many of the side effects commonly associated with standard cancer treatments. However, flu-like symptoms, infusion reactions,
rashes, and moderate to severe diarrhea have
been reported with the use of some immunotherapy drugs. And because immunotherapy
can activate the immune system, there is a risk
that certain immunotherapy drugs may cause
more serious autoimmune reactions, known
as immune-related adverse events (IRAEs),
when the immune system reacts against normal body organs. However, most side effects
associated with immunotherapy are easily
manageable if treated early, so be sure to talk
>>
14
to your doctor about what to expect before
treatment begins, and carefully monitor how
you feel during and after treatment.
Is immunotherapy right for me?
Some immunotherapy treatments are
patient-specific and depend on the exact type
of cancer you have, and your doctor will need
to determine your eligibility based on treatment criteria. Participation in an immunotherapy clinical trial will also have specific
qualification guidelines, which may include
diagnosis, general health and treatment history. Because cancer immunotherapy is dependent on a functioning immune system, it
will likely be important that you not have any
autoimmune disorders and are not taking any
chronic immunosuppressive medications. Be
sure to discuss all of your available treatment
options with your doctor to determine the
best treatment for your specific diagnosis.
Immunotherapy may be considered as treatment alone or in combination with other
treatments and immunotherapies.
>>
your treatments in a specific facility on a very
strict regimen. Some treatments require hospitalization, while others can be given safely
in an outpatient clinic or doctor’s office.
How long until we know whether treatment
is effective?
Immunotherapy is a different form of
cancer treatment, so measuring results can
also be different. The effectiveness of standard treatments is typically measured in
both progression-free survival and overall
survival. With chemotherapy, an increase
in tumor size or the presence of new tumors
is considered disease progression and often
means the treatment isn’t working. With immunotherapy, however, the immune system
needs time to mount an effective immune
attack, which may result in a delayed response. During this time, tumors may continue to grow or new tumors may appear
before the body can effectively target and
destroy the cancer cells. As a result, many
immunotherapy treatments may not show
>>
How do I get started?
doctor should discuss any FDA-approved immunotherapy
>>drugsYouthatandareyourapplicable
to your diagnosis, as well as any available clinical
trials within a reasonable traveling distance for you. The National Cancer Institute (NCI) maintains a list of current clinical trials that can be accessed at
www.clinicaltrials.gov. Once you have determined your best options, do your
research and talk to your doctor about any additional questions you have so
you can make informed decisions throughout the treatment process.
How are immunotherapy treatments
administered?
Your treatment regimen will depend on
the treatment you receive. For example, the
immunotherapy cancer vaccine sipuleucel-T
(PROVENGE) requires biweekly visits – one
for collecting the immune cells and another
for the intravenous vaccination injection –
over the course of three weeks. Typically,
immunotherapy treatments are given intravenously and may require specialized centers
with physicians and staff members who have
been trained in the delivery of specific immunotherapy drugs. If you’re participating in a
clinical trial, you may be required to receive
>>
a significant increase in progression-free
survival but over time may offer more longlasting and life-extending benefits.
The duration of your treatment will depend on the specific treatment type and
your individual response to the medication.
Some patients may need to continue treatments over an extended period of time in
order to keep the immune system engaged.
Some immunotherapy treatments, however,
have shown responses that last beyond the
end of treatment. You should discuss your
response with your doctor and remember
that sometimes progress may take several
weeks or even months. n
9/17/2014 9:28:06 AM
ADVOCACY & FINANCIAL RESOURCES
Cancer education
Academy of Oncology Nurse Navigators.......................................................... www.aonnonline.org
Alex’s Lemonade Stand Foundation for Childhood Cancer..........................www.alexslemonade.org
American Cancer Society...........................................................................................www.cancer.org
American Society of Clinical Oncology (patient website).........................................www.cancer.net
Association of Community Cancer Centers...................................................... www.accc-cancer.org
CANCER101........................................................................................................ www.cancer101.org
CancerCare......................................................................................................... www.cancercare.org
CancerGuide..................................................................................................... www.cancerguide.org
The Cancer Project......................................................................................... www.cancerproject.org
CancerQuest..................................................................................................... www.cancerquest.org
The Center for Cancer Support & Education..............................................www.centerforcancer.org
Centers for Disease Control and Prevention................................................................. www.cdc.gov
The Gathering Place....................................................................................... www.touchedbycancer.org
GetPalliativeCare.org................................................................................www.getpalliativecare.org
Global Resource for Advancing Cancer Education.......................................... www.cancergrace.org
The Hope Light Foundation...................................................................... www.hopelightproject.com
LIVESTRONG Foundation..................................................................................... www.livestrong.org
National Cancer Institute......................................................................................... www.cancer.gov
National Comprehensive Cancer Network...................................................................www.nccn.org
OncoLink..................................................................................................................www.oncolink.org
PearlPoint Cancer Support...................................................................................www.pearlpoint.org
Pine Street Foundation...................................................................... www.pinestreetfoundation.org
R.A. Bloch Cancer Foundation Inc.....................................................................www.blochcancer.org
Scott Hamilton CARES Initiative......................................................................... www.scottcares.org
Union for International Cancer Control..........................................................................www.uicc.org
U.S. National Library of Medicine...........................................................................www.nlm.nih.gov
Wellness Place..............................................................................................www.wellnessplace.org
Caregivers & support
4th Angel Mentoring Program...............................................................................www.4thangel.org
American Self-Help Group Clearinghouse................................................... www.selfhelpgroups.org
Bloch Cancer Hotline.....................................................................................................800-433-0464
Buddy Kemp Caring House..........................................................www.presbyterian.org/buddykemp
CANCER101........................................................................................................ www.cancer101.org
Cancer Action...............................................................................................www.canceractionkc.org
Cancer and Careers................................................................................. www.cancerandcareers.org
CancerCare......................................................................................................... www.cancercare.org
Cancer Connection............................................................................. www.thecancerconnection.org
Cancer Hope Network.......................................................................... www.cancerhopenetwork.org
Cancer Information and Counseling Line.......................................................................800-525-3777
Cancer Really Sucks!.............................................................................. www.cancerreallysucks.org
Cancer Support Community.........................................................www.cancersupportcommunity.org
Cancer Support Community Open to Options counseling program...............................888-793-9355
Cancer Survivors Network..................................................................................http://csn.cancer.org
Cancer Survivors On Line............................................................................www.cancersurvivors.org
Cancer Wellness Center.............................................................................www.cancerwellness.org
Caregiver Action Network......................................................................... http://caregiveraction.org
CaringBridge....................................................................................................www.caringbridge.org
The Center for Cancer Support & Education..............................................www.centerforcancer.org
Center to Advance Palliative Care................................................................................www.capc.org
The Children’s Treehouse Foundation..............................................www.childrenstreehousefdn.org
Cleaning for a Reason...........................................................................www.cleaningforareason.org
Cuddle My Kids.............................................................................................. www.cuddlemykids.org
Family Caregiver Alliance..................................................................................... www.caregiver.org
Fighting Chance........................................................................................... www.fightingchance.org
Friend for Life Cancer Support Network............................................................. www.friend4life.org
The Gathering Place..................................................................................www.touchedbycancer.org
Guam Cancer Care....................................................................................http://guamcancercare.org
Guide Posts of Strength Inc.................................................................................www.cancergps.org
The Hope Light Foundation...................................................................... www.hopelightproject.com
Imerman Angels.......................................................................................... www.imermanangels.org
The LGBT Cancer Project – Out With Cancer..................................................... www.lgbtcancer.org
LivingWell Cancer Resource Center................................................................www.livingwellcrc.org
Lotsa Helping Hands.............................................................................www.lotsahelpinghands.com
MyLifeLine.org Cancer Foundation...................................................................... www.mylifeline.org
The Patient Partner Project.......................................................... www.thepatientpartnerproject.org
PearlPoint Cancer Support.................................................................................. www.pearlpoint.org
SHARE Caregiver Circle for Family and Friends
...........................www.sharecancersupport.org/share-new/support/for_partners_and_caregivers
Strike Out Cancer.......................................................................................www.strikeoutcancer.com
Turning Point.................................................................................................www.turningpointkc.org
The Ulman Cancer Fund for Young Adults......................................................... http://ulmanfund.org
Visiting Nurse Associations of America...................................................................... www.vnaa.org
Vital Options International................................................................................ www.vitaloptions.org
Walk With Sally.............................................................................................www.walkwithsally.org
Wellness Place..............................................................................................www.wellnessplace.org
Well Spouse Association...................................................................................www.wellspouse.org
weSPARK (Cancer Support Center)........................................................................ www.wespark.org
Wonders & Worries.............................................................................www.wondersandworries.org
Chemotherapy
Chemocare.com................................................................................................www.chemocare.com
The Chemotherapy Foundation.................................................. www.chemotherapyfoundation.com
Complementary programs & alternative medicine
The Annie Appleseed Project......................................................... www.annieappleseedproject.org
Believe Big.......................................................................................................... www.believebig.org
The Cancer Project......................................................................................... www.cancerproject.org
The Center for Mind-Body Medicine......................................................................... www.cmbm.org
Exceptional Cancer Patients............................................................................. www.ecap-online.org
Kansas City Healing Touch...........................................................www.kansascityhealingproject.org
National Center for Complementary and Alternative Medicine........................ www.nccam.nih.gov
Office of Cancer Complementary and Alternative Medicine...........................www.cancer.gov/cam
Society for Oncology Massage................................................................................... www.s4om.org
Stewart’s Caring Place: Cancer Wellness Center............................... www.stewartscaringplace.org
Touch, Caring and Cancer........................................................................www.partnersinhealing.net
Financial assistance
American Cancer Society...........................................................................................www.cancer.org
American Kidney Fund....................................................................................... www.kidneyfund.org
BenefitsCheckUp........................................................................................www.benefitscheckup.org
Bringing Hope Home..............................................................................www.bringinghopehome.org
CancerCare..........................................................................................www.cancercare.org/financial
Cancer Financial Assistance Coalition................................................................ www.cancerfac.org
The CHAIN Fund............................................................................................ www.thechainfund.com
HealthWell Foundation..................................................................... www.healthwellfoundation.org
Medicare...............................................................................................................www.medicare.gov
Native American Cancer Research................................................................. www.natamcancer.org
NeedyMeds...................................................................................................... www.needymeds.com
Partnership for Prescription Assistance..................................................................... www.pparx.org
Patient Access Network Foundation............................................................www.panfoundation.org
Patient Advocate Foundation:....................................................................www.patientadvocate.org
Patient Services Inc................................................................................www.patientservicesinc.org
RxAssist...................................................................................................................www.rxassist.org
RxHope.....................................................................................................................www.rxhope.com
Social Security Administration...................................................................................... www.ssa.gov
The Social Security and Disability Resource Center................................................. www.ssdrc.com
State Health Insurance Assistance Program.......................................................... www.shiptalk.org
Stupid Cancer...................................................................................................www.stupidcancer.org
Immunotherapy
TheAnswertoCancer.org........................................................................ www.theanswertocancer.org
Cancer Research Institute........................................................................... www.cancerresearch.org
Society for Immunotherapy of Cancer...................................................................www.sitcancer.org
Mental health services
American Psychosocial Oncology Society Helpline.......................................................866-276-7443
Pain management
American Chronic Pain Association........................................................................ www.theacpa.org
Cancer Pain Research Consortium..................................admin@cancerpainresearchconsortium.org
National Foundation for the Treatment of Pain..............................................................www.nih.gov
Painfromcancer.org..................................................................................... www.painfromcancer.org
U.S. Pain Foundation............................................................................... http://uspainfoundation.org
15
9/17/2014 9:28:06 AM
CLINICAL TRIALS in cancer immunotherapy
P
rior to approval, new drugs being tested for safety
and effectiveness are called “investigational” or
“experimental” medications. Clinical trials are the
controlled studies of these investigational drugs.
The main goal of clinical trials is to validate a
drug’s safety and effectiveness, but they also help determine a
variety of other factors, including the drug’s associated side effects and recommended dosages. The results of clinical trials
help the Food and Drug Administration (FDA) decide whether
to approve the drugs and release them for public use.
In some cases, patients may want to participate in a clinical trial to gain access to certain medications before they’re
officially approved by the FDA. Patients who participate in
clinical trials are offered a number of benefits, including early
access to potentially revolutionary new medications, playing
an important role in advancing medical research, and receiving the very best standard of care with close monitoring by
experts in the field.
Cancer immunotherapy clinical trials study ways to treat
cancer through immunotherapy. There are currently hundreds
of clinical trials in various stages studying innovative immunotherapy drugs as new treatments, in combination with other
ANAL - BREAST
treatments or as new uses for already approved treatments.
Without patient participation in clinical trials, the immunotherapy treatments that exist today wouldn’t be available.
To qualify for a clinical trial, each patient must meet certain
eligibility criteria. Cancer type, overall health and treatment
history may be considerations depending on the type or phase
of the trial. Because cancer immunotherapy is dependent on
immune system function, a properly functioning immune system is often a qualifying factor for immunotherapy clinical trials. The clinical trial staff will be able to determine whether you
are eligible to participate in a specific trial.
Current clinical trials with open recruitment as of
Aug. 21, 2014, are displayed on the following pages. (See
www.clinicaltrials.gov for a complete and current list of
trials.) Each trial is either “Recruiting” or “Not yet recruiting,” which means the studies are either actively recruiting
participants or getting ready to start the recruiting process.
The NCT number is a unique identification code assigned
to each clinical study that is registered on the website. You
can find more information about a specific clinical trial by
entering the trial record number into the search box located
at the top of the Web page.
CANCER IMMUNOTHERAPY CLINICAL TRIALS BY DISEASE
Includes all studies categorized as immunotherapy cancer trials by the U.S. National Institutes of Health at www.clinicaltrials.gov
ANAL
Title
Cancer Type
Treatment
Location
NCT Number
A Phase II Study of Lymphodepletion Followed by
Autologous Tumor-Infiltrating Lymphocytes and
High-Dose Adesleukin for Human PapillomavirusAssociated Cancers
Cervical Cancer, Oropharyngeal
Cancer, Vaginal Cancer, Anal Cancer,
Penile Cancer
Drug: fludarabine; Drug: cyclophosphamide;
Biological: Young TIL; Drug: aldesleukin
MD
NCT01585428
Title
Cancer Type
Treatment
Location
NCT Number
Evaluation for NCI Surgery Branch Clinical Studies
Synovial Cell Cancer, Melanoma,
Colorectal Cancer, Lung Cancer,
Bladder Cancer
MD
NCT00001823
A Study of ALT-801 in Combination With Cisplatin
and Gemcitabine in Muscle Invasive or Metastatic
Urothelial Cancer
Transitional Cell Carcinoma of Bladder,
Urethra Cancer, Ureter Cancer,
Malignant Tumor of Renal Pelvis
Drug: cisplatin; Drug: gemcitabine;
Biological: ALT-801
AZ; CA; FL; GA; IA;
IL; KS; LA; MI; MO;
NC; NY; OK; PA
NCT01326871
A Study of ALT-801 in Patients With Bacillus
Calmette-Guerin (BCG) Failure Non-Muscle Invasive
Bladder Cancer
Non-muscle Invasive Bladder Cancer
Biological: ALT-801; Drug: gemcitabine
AL; CA; FL; NC;
OK; PA
NCT01625260
A Phase I/II Study of HS-410 in Patients With Non-Muscle
Invasive Bladder Cancer After TURBT
Bladder Cancer
Biological: HS-410; Biological: Placebo;
Biological: BCG
CA; CO; IL; IN;
KS; MA; MD; NC;
SC; TX
NCT02010203
Study of Bacillus Calmette-Guerin (BCG) Combined With
PANVAC Versus BCG Alone in Adults With High Grade
Non-Muscle Invasive Bladder Cancer Who Failed At Least
1 Course of BCG
Bladder Cancer
Biological: TICE Bacillus Calmette-Guerin
(BCG); Biological: PANVAC
MD; NJ
NCT02015104
A Study of Intravesical Bacillus Calmette-Guerin (BCG)
in Combination With ALT-803 in Patients With BCG-naive
Non-Muscle Invasive Bladder Cancer
Non-muscle Invasive Bladder Cancer
Biological: ALT-803
HI
NCT02138734
Safety and Efficacy of CG0070 Oncolytic Virus Regimen
in Patients With High Grade Non-Muscle Invasive
Bladder Cancer
Bladder Cancer, High Grade, Non
Muscle Invasive
Biological: oncolytic adenovirus
expressing GM-CSF
AZ
NCT02143804
BLADDER
16
2014 Immunotherapy - Clinical Trials Section.indd 16
9/17/2014 9:16:06 AM
BRAIN
Title
Cancer Type
Treatment
Location
NCT Number
Study of a Drug [DCVax®-L] to Treat Newly Diagnosed
GBM Brain Cancer
Glioblastoma Multiforme,
Glioblastoma, GBM, Grade IV
Astrocytoma, Glioma, Brain Cancer,
Brain Tumor
Drug: Dendritic cell immunotherapy
AR; CA; CO; DC;
FL; GA; IL; IN; KS;
MA; MI; MN; MO;
NC; NJ; NY; OH;
PA; RI; SC; TN;
TX; WA
NCT00045968
Vaccine Therapy and GM-CSF in Treating Patients With
CNS Lymphoma
Brain and Central Nervous
System Tumors, Lymphoma,
Lymphoproliferative Disorder, Small
Intestine Cancer
Biological: Autologous immunoglobulin
idiotype-KLH conjugate vaccine; Biological:
sargramostim; Drug: methotrexate; Drug:
thiotepa; Radiation: Radiation therapy
TX
NCT00621036
Basiliximab in Treating Patients With Newly Diagnosed
Glioblastoma Multiforme Undergoing Targeted
Immunotherapy and Temozolomide-Caused Lymphopenia
Malignant Neoplasms Brain
Biological: RNA-loaded dendritic cell vaccine;
Drug: basiliximab
NC
NCT00626483
A Phase I Study of AdV-tk + Prodrug Therapy in
Combination With Radiation Therapy for Pediatric
Brain Tumors
Malignant Glioma,
Recurrent Ependymoma
Biological: AdV-tk; Drug: valacyclovir;
Radiation: Radiation
IL; MA
NCT00634231
Cellular Immunotherapy Study for Brain Cancer
Gliomas, Anaplastic Astrocytoma,
Anaplastic Oligodendroglioma,
Anaplastic Mixed Glioma, Glioblastoma
Multiforme, Malignant Meningioma
Drug: alloreactive CTL
CA
NCT01144247
Dendritic Cell Vaccine for Patients With Brain Tumors
Glioma, Anaplastic Astrocytoma,
Anaplastic Astro-oligodendroglioma,
Glioblastoma
Biological: autologous tumor lysate-pulsed
DC vaccination; Biological: Tumor lysatepulsed DC vaccination + 0.2% resiquimod;
Biological: Tumor-lysate pulsed DC
vaccination + adjuvant polyICLC
CA
NCT01204684
Vaccine Immunotherapy for Recurrent Medulloblastoma
and Primitive Neuroectodermal Tumor
Medulloblastoma,
Neuroectodermal Tumor
Biological: TTRNA-xALT; Biological:
TTRNA-DCs
FL
NCT01326104
White Blood Cells With Anti-EGFR-III for
Malignant Gliomas
Malignant Glioma, Glioblastoma,
Brain Cancer
Biological: Anti-EGFRvIII CAR transduced
PBL; Drug: aldesleukin; Drug: fludarabine;
Drug: cyclophosphamide
MD
NCT01454596
Vaccine Therapy With or Without Sirolimus in Treating
Patients With NY-ESO-1 Expressing Solid Tumors
Multiple Cancer Types
Biological: DEC-205-NY-ESO-1 fusion protein
vaccine; Drug: sirolimus; Other: laboratory
biomarker analysis
NY
NCT01522820
Immune Reconstitution in Oncology Patients Following
Autologous Stem Cell Transplant
Solid Tumor, Brain Tumor, Lymphoma
Other: Blood samples obtained
TN
NCT01540175
Study to Evaluate the Effects of Imiquimod and Tumor
Lysate Vaccine Immunotherapy in Adults With High Risk
or Recurrent/Post-Chemotherapy WHO Grade II Gliomas
High Risk WHO Grade II Glioma,
Recurrent/Post-Chemotherapy WHO
Grade II Glioma
Biological: Tumor lysate vaccine;
Drug: imiquimod
PA
NCT01678352
Phase I Study of a Dendritic Cell Vaccine for Patients
With Either Newly Diagnosed or Recurrent Glioblastoma
Glioblastoma, Glioblastoma
Multiforme, Glioma, Astrocytoma,
Brain Tumor
Biological: Dendritic cell vaccination,
in addition to standard temozolomide
chemotherapy and involved field radiation
therapy; Biological: Dendritic cell
vaccination, with optional bevacizumab
treatment for patients previously treated
with bevacizumab
CA
NCT02010606
Efficacy Study of Oral Arginine to Improve Immune
Function in Glioblastoma Multiforme
Glioblastoma Multiforme
Drug: arginine in powder form
VA
NCT02017249
A Study of ICT-121 Dendritic Cell Vaccine in
Recurrent Glioblastoma
Recurrent Glioblastoma
Biological: ICT-121 DC vaccine
CA
NCT02049489
Safety and Efficacy Study of SL-701, a Glioma-Associated
Antigen Vaccine To Treat Recurrent Glioblastoma
Multiforme
Adult Brain Glioblastoma,
Glioblastoma Multiforme
Biological: SL-701; imiquimod cream 5%;
Leukine 150 micrograms; Drug: imiquimod
cream 5%; Drug: Leukine 150 micrograms
AZ; IL; MA; MI; NY
NCT02078648
RESIST: Patients With IDH1 Positive Recurrent Grade II
Glioma Enrolled in a Safety and Immunogenicity Study of
Tumor-Specific Peptide Vaccine
Brain Cancer, Brain Neoplasm, Primary,
Brain Neoplasms, Recurrent, Brain
Tumor, Cancer of the Brain
Biological: PEPIDH1M vaccine
NC
NCT02193347
DNX-2401 With Interferon Gamma (IFN-y) for Recurrent
Glioblastoma or Gliosarcoma Brain Tumors
Glioblastoma, Gliosarcoma
Drug: Single intratumoral injection of DNX2401; Drug: interferon gamma
AR; FL; OH; TX
NCT02197169
Genetically Modified T cells in Treating Patients With
Recurrent or Refractory Malignant Glioma
Biological: IL13Ra2-specific, hingeoptimized, 41BB-costimulatory CAR/
truncated CD19-expressing T lymphocytes;
Other: Laboratory biomarker analysis;
Other: Quality-of-life assessment
CA
NCT02208362
Title
Cancer Type
Treatment
Location
NCT Number
Collection of Blood From Patients With Cancer
Prostate Cancer, Breast Cancer, Colon
Cancer, Lung Cancer, Liver Cancer
MD
NCT00034216
Laboratory-Treated T Cells After Second-Line
Chemotherapy in Treating Women With HER2/
Neu-Negative Metastatic Breast Cancer
Breast Cancer
MI
NCT01022138
BREAST
Biological: HER2Bi-armed activated T cells;
Drug: cyclophosphamide; Other: Laboratory
biomarker analysis
17
9/17/2014 9:16:06 AM
CLINICAL TRIALS
BREAST - HEAD & NECK
BREAST (CONTINUED)
Title
Cancer Type
Treatment
Location
NCT Number
Targeted T Cells After Neoadjuvant Chemotherapy in
Treating Women With Stage II or Stage III Breast Cancer
Undergoing Surgery
Breast Cancer
Biological: HER2Bi-armed activated T cells;
Drug: cyclophosphamide; Drug: doxorubicin
hydrochloride; Drug: paclitaxel; Other:
laboratory biomarker analysis; Procedure:
neoadjuvant therapy; Procedure: Therapeutic
conventional surgery
MI
NCT01147016
Evaluation of an Anti-cancer Immunotherapy Combined
With Standard Neoadjuvant Treatment in Patients With
WT1-positive Primary Invasive Breast Cancer
Neoplasms, Breast
Biological: GSK Biologicals’ recombinant WT1 AR; DE; FL; MA;
Antigen-Specific Cancer Immunotherapeutic MI; NC; OR; SC;
(ASCI) GSK2302024A; Biological: Placebo
TN; TX; WA
NCT01220128
Vaccine Therapy in Treating Patients With Metastatic
Solid Tumors
Malignant Solid Tumor, Breast Cancer,
Malignant Tumor of Colon, GIST,
Ovarian Cancer
Biological: HER2 vaccine
OH
NCT01376505
Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio
Immunotherapy
Breast Neoplasms, Peritoneal
Neoplasms, Ovarian Neoplasms,
Pancreatic Neoplasms, Stomach
Neoplasms
Other: ²¹²Pb-TCMC-Trastuzumab,
Biological: trastuzumab
AL; CA
NCT01384253
Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and
Radiotherapy for Breast Cancer With Skin Metastases
Breast Cancer, Metastatic Breast Cancer,
Recurrent Breast Cancer
Radiation: Radiation; Drug: imiquimod; Drug:
cyclophosphamide
NY
NCT01421017
A Phase I Study To Evaluate The Antitumor Activity And
Safety Of AVX901
HER2+ Cancer
Biological: AVX901
NC
NCT01526473
Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for
Breast Cancer
Breast Cancer
Biological: 9 Peptides from HER2/neu, CEA, &
CTA + poly-ICLC
VA
NCT01532960
Combination Immunotherapy With Herceptin and the
HER2 Vaccine NeuVax
Breast Cancer
Drug: Herceptin; Drug: NeuVax vaccine;
Drug: GM-CSF
CA; DC; HI; IN; MD;
OR; PA; TX; VA; WA
NCT01570036
Vaccine Therapy and Trastuzumab With or Without
Polysaccharide-K in Treating Patients With Stage IV
HER2 Positive Breast Cancer
HER2-positive Breast Cancer, Male
Breast Cancer, Recurrent Breast Cancer,
Stage IV Breast Cancer
Biological: HER2/neu intracellular domain
protein; Biological: trastuzumab; Other:
placebo; Biological: polysaccharide-K;
Other: laboratory biomarker analysis
WA
NCT01922921
Exemestane and Cyclophosphamide for Metastatic
Breast Cancer
Metastatic Beast Cancer
Drug: exemestane; Drug: cyclophosphamide
NY
NCT01963481
Intrapleural AdV-tk Therapy in Patients With Malignant
Pleural Effusion
Malignant Pleural Effusion, Lung Cancer,
Mesothelioma, Breast Cancer,
Ovarian Cancer
Biological: AdV-tk + valacyclovir
PA
NCT01997190
A Phase I Trial of NY-ESO-1 With GLA-SE in Patients With
Unresectable or Metastatic Cancer
Melanoma, Ovarian Cancer,
Sarcoma, Non-Small Cell Lung Cancer,
Breast Cancer
Biological: IDC-G305
AZ; FL; MI; NY
NCT02015416
Increased Frequency of AlloStim™ Dosing in Combination
With Cryoablation in Metastatic Breast Cancer Patients
Metastatic Breast Cancer
Biological: AlloStim; Procedure: Cryoablation
CA
NCT02018419
DC Vaccine for Patients With Ductal Carcinoma In Situ
Breast Cancer, DCIS
Biological: HER2 pulsed dendritic cell vaccine
PA
NCT02061332
HER2 Pulsed DC Vaccine to Prevent Recurrence of Invasive
Breast Cancer Post Neoadjuvant Chemotherapy
Breast Cancer
PA
NCT02061423
HER2 Pulsed DC Vaccine to Prevent Recurrence of Invasive
Breast Cancer
Breast Cancer
PA
NCT02063724
A Phase I Safety Study of Intradermal ID-LV305 in Patients
With Locally Advanced, Relapsed or Metastatic Cancer
Expressing NY-ESO-1
Breast Cancer, Melanoma,
Non-Small Cell Lung Cancer,
Ovarian Cancer, Sarcoma
Biological: ID-LV305
CT; MA; MN;
TX; WA
NCT02122861
Safety and Tolerability of a Modified Vaccinia Ankara
(MVA)-Based Vaccine Modified to Express Brachyury and T
cell Costimulatory Molecules (MVA-Brachyury-TRICOM)
Lung Cancer, Breast Cancer,
Prostate Cancer, Tumors (Others)
Biological: MVA-brachyury-TRICOM
MD
NCT02179515
Title
Cancer Type
Treatment
Location
NCT Number
Autologous Tumor-Infiltrating Lymphocytes and High-Dose
Adesleukin for Human Papillomavirus-Associated Cancers
Cervical Cancer, Oropharyngeal Cancer,
Vaginal Cancer, Anal Cancer,
Penile Cancer
MD
NCT01585428
ADXS11-001 High Dose HPV+ Cervical Cancer
Effects of Immunotherapy, Metastatic/
Recurrent Cervical Cancer, Cervical
Adenocarcinoma, Cervical
Adenosquamous Cell Carcinoma, Cervical
Squamous Cell Carcinoma, Cervical Small
Cell Carcinoma, Stage III Cervical Cancer,
Stage IVA Cervical Cancer, Stage IVB
Cervical Cancer
Biological: ADXS11-001
GA
NCT02164461
CERVICAL
18
9/17/2014 9:16:06 AM
COLORECTAL
Title
Cancer Type
Location
NCT Number
Bladder Cancer
Treatment
MD
NCT00001823
MD
NCT00034216
A Phase II Study Using Short-Term Cultured, CD8+-Enriched
Autologous Tumor-infiltrating Lymphocytes Following a
Lymphocyte Depleting Regimen in Metastatic Digestive
Tract Cancers
Metastatic Colorectal Cancer,
Metastatic Gastric Cancer, Metastatic
Pancreatic Cancer, Metastatic
Hepatocellular Carcinoma, Metastatic
Cholangiocarcinoma
Biological: Young TIL; Drug: aldesleukin;
Drug: cyclophosphamide; Drug: fludarabine
MD
NCT01174121
Treating Metastatic Cancer With Anti-VEGFR2 Gene
Engineered CD8+ Lymphocytes
Metastatic Cancer, Metastatic
Melanoma, Renal Cancer, Colorectal
Cancer, Ovarian Cancer, Lung Cancer
Genetic: Anti-VEGFR2 CAR CD8 plus PBL;
Drug: cyclophosphamide; Drug: aldesleukin;
Drug: fludarabine
MD
NCT01218867
Solid Tumors
Malignant Solid Tumor, Breast Cancer,
Ovarian Cancer
OH
NCT01376505
Anti-CD3 x Anti-Erbitux® Armed Activated T Cells (Phase Ib)
for Gastrointestinal (GI Cancer)
Colorectal Cancer, Cancer of Pancreas,
Pancreatic Neoplasm, Malignant
Neoplasm of Large Intestine, Malignant
Tumor of Colon, Colon Carcinoma,
Cancer of Colon, Pancreatic Cancer
Drug: FOLFOX6; Biological: EGFRBi armed
ATC infusions
MI
NCT01420874
Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in
Patients With Stage III Colorectal Cancer
Stage III Colon Cancer
Biological: AVX701
NC
NCT01890213
Title
Cancer Type
Treatment
Location
NCT Number
INCB024360 Before Surgery in Treating Patients With Newly
Diagnosed Stage III-IV Epithelial Ovarian, Fallopian Tube, or
Primary Peritoneal Cancer
Stage IIIA Fallopian Tube Cancer, Stage
IIIA Ovarian Epithelial Cancer, Stage
IIIA Primary Peritoneal Cavity Cancer,
Stage IIIB Fallopian Tube Cancer, Stage
IIIB Ovarian Epithelial Cancer, Stage
IIIB Primary Peritoneal Cavity Cancer,
Stage IIIC Fallopian Tube Cancer, Stage
IIIC Ovarian Epithelial Cancer, Stage
IIIC Primary Peritoneal Cavity Cancer,
Stage IV Fallopian Tube Cancer, Stage
IV Ovarian Epithelial Cancer, Stage IV
Primary Peritoneal Cavity Cancer
Drug: IDO1 inhibitor INCB024360;
Procedure: Therapeutic conventional surgery;
Other: Laboratory biomarker analysis
MN; NY
NCT02042430
Title
Cancer Type
Treatment
Location
NCT Number
MAGE-A3/HPV 16 Vaccine for Squamous Cell Carcinoma of
the Head and Neck
Squamous Cell Carcinoma of the Head
and Neck
Biological: MAGE-A3;
Biological: HPV-16 vaccine
MD
NCT00257738
Vitamin D - Celecoxib Therapy
Mouth Neoplasms
Drug: celecoxib; Drug: 1,25-dihydroxyvitamin D3 SC
+ celecoxib; Drug: 1,25-dihydroxyvitamin D3
NCT00953849
Pilot Study of Allogeneic Tumor Cell Vaccine With
Metronomic Oral Cyclophosphamide and Celecoxib in
Patients Undergoing Resection of Lung and Esophageal
Cancers, Thymic Neoplasms, and Malignant Pleural
Mesotheliomas
Lung Cancer, Esophageal Cancer,
Malignant Pleural Mesothelioma,
Sarcoma, Thymic Carcinoma
Biological: Allogeneic tumor cell
vaccine (K562); Drug: celecoxib;
MD
NCT01143545
TLR8 Agonist VTX-2337 and Cetuximab in Treating Patients
With Locally Advanced, Recurrent, or Metastatic Squamous
Cell Cancer of Head and Neck
Drug: TLR8 agonist VTX-2337; Biological:
cetuximab; Other: Laboratory biomarker
analysis; Other: pharmacogenomic studies
WA
NCT01334177
Safety Study of HPV DNA Vaccine to Treat Head and Neck
Cancer Patients
HPV-related Head and Neck Cancer
Biological: pNGVL-4a-CRT/E7 (detox)
DNA vaccine
MD
NCT01493154
Penile Cancer
MD
NCT01585428
A Phase II Trial of Tadalafil in Patients With Squamous Cell
Carcinoma of the Upper Aero Digestive Tract
Head and Neck Squamous Cell
Carcinoma
Drug: tadalafil; Drug: Placebo
MD
NCT01697800
Recombinant Interleukin-15 in Treating Patients With
Advanced Melanoma, Kidney Cancer, Non-Small Cell Lung
Cancer, or Squamous Cell Head and Neck Cancer
Biological: Recombinant interleukin-15,
Other: Pharmacological study;
CA; MD; MN;
WA; WI
NCT01727076
Window of Opportunity Trial of ADXS 11-001
Vaccination Prior to Robotic Surgery of HPV-Positive
Oropharyngeal Cancer
Head and Neck Cancer, Squamous Cell
Carcinoma of the Head and Neck, Human
Papillomavirus Positive Oropharyngeal
Squamous Cell Carcinoma
Biological: ADXS11-001 (ADXS-HPV)
NY
NCT02002182
FALLOPIAN TUBE
HEAD & NECK
19
9/17/2014 9:16:07 AM
CLINICAL TRIALS
HEAD & NECK - LEUKEMIA/LYMPHOMA/MULTIPLE MYELOMA
HEAD & NECK (CONTINUED)
Adjuvant Tumor Lysate Vaccine and Iscomatrix With or
Without Metronomic Oral Cyclophosphamide and Celecoxib
in Patients With Malignancies Involving Lungs, Esophagus,
Pleura, or Mediastinum
Biological: H1299 lysate vaccine; Drug:
cyclophosphamide; Drug: celecoxib
MD
NCT02054104
Study of HPV Specific Immunotherapy in Patients With HPV
Associated Head and Neck Squamous Cell Carcinoma
Head and Neck Squamous Cell Cancer
Biological: 1.1 mL of VGX-3100 and INO-9012
delivered via IM EP
PA
NCT02163057
Peripheral Stem Cell Transplant in Treating Patients With
Metastatic Kidney Cancer
Kidney Cancer
Biological: Anti-thymocyte globulin; Drug:
cyclophosphamide; Drug: cyclosporine; Drug:
fludarabine phosphate; Drug: methotrexate;
Drug: mycophenolate mofetil
MD
NCT00003553
Drug: fludarabine
MD
NCT01218867
Phase III Trial of Autologous Dendritic Cell Immunotherapy
(AGS-003) Plus Standard Treatment of Advanced Renal Cell
Carcinoma (RCC)
Advanced Renal Cell Carcinoma,
Renal Cell Carcinoma, Metastatic Renal
Cell Carcinoma
Drug: Standard treatment; Biological: AGS-003
AK; AZ; CA; CO; CT;
FL; GA; IA; ID; IL;
IN; KS; KY; LA; MA;
MD; MI; MN; MO;
NC; NE; NH; NJ;
NM; NY; OH; OK;
OR; PA; RI; SC; TN;
TX; UT; VA; WA; WI
NCT01582672
Reference Group Trial for The ONE Study
End-stage Renal Failure,
Kidney Graft Rejection
Other: Blood drawing for immune monitoring
and questionnaires
CA; MA
NCT01656135
PET Quantitative Assessments of Solid Tumor Response to
Immune Checkpoint Blockade Therapy
Melanoma, Renal Cell Carcinoma (RCC),
Non-Small Cell Lung Cancer (NSCLC)
Radiation: PET/CT imaging with [18F]
2-deoxy-2-(18F)fluoro-D-glucose (FDG)
MD
NCT01666353
High Dose IL-2 and Stereotactic Ablative Body Radiation
Therapy for Metastatic Renal Cancer
Metastatic Clear Cell Renal
Cell Carcinoma
Drug: IL-2; Radiation: Stereotactic ablative
body radiation therapy
TX
NCT01896271
Vaccine Therapy Before Surgery in Treating Patients With
Localized Kidney Cancer
Recurrent Renal Cell Cancer,
Stage I Renal Cell Cancer,
Stage II Renal Cell Cancer
Biological: Renal cell carcinoma/CD40L RNAtransfected autologous dendritic cell vaccine
AGS-003; Procedure: Therapeutic conventional
surgery; Other: Laboratory biomarker analysis
NY
NCT02170389
A Rollover Protocol for Subjects Previously Treated With
AGS-003
Renal Cell Carcinoma
Drug: AGS-003
GA; IN; MN;
NC; VA
NCT01482949
Title
Cancer Type
Treatment
Location
NCT Number
ATC infusions
MI
NCT01420874
KIDNEY
LARGE INTESTINE
LEUKEMIA /LYMPHOMA /MULTIPLE MYELOMA
Title
Cancer Type
Treatment
Location
NCT Number
Biological Therapy in Treating Patients at High-Risk or With
Lymphoma, Lymphoproliferative Disease, or Malignancies
Leukemia, Lymphoma, Unspecified
Adult Solid Tumor, Protocol Specific,
Unspecified Childhood Solid Tumor,
Protocol Specific
Biological: Allogeneic Epstein-Barr virusspecific cytotoxic T lymphocytes
NY
NCT00002663
Xcellerated T Cells™ for Non-Hodgkin Lymphoma
(NHL) Patients
Non-Hodgkin Lymphoma
Drug: Xcellerated T Cells
CA; CO; GA; MA;
MD; MO; NJ; OH,
OR; SC; TX; WA
NCT00081783
HLA-Nonidentical Stem Cell and Natural Killer Cell
Transplantation for Children Less the Two Years of Age With
Hematologic Malignancies
Acute Myeloid Leukemia, Acute
Lymphocytic Leukemia, Myelodysplasia,
Chronic Myeloid Leukemia, Histiocytosis
Drug: Chemotherapy and antibodies; Device:
Miltenyi Biotec CliniMACS; Procedure:
Allogeneic stem cell transplantation
TN
NCT00145626
Rituximab, Vaccine Therapy, and GM-CSF in Treating
Patients With Non-Hodgkin Lymphoma
Lymphoma
rituximab; Biological: sargramostim
TN
NCT00258336
Allogeneic Blood Stem Cell Transplantation and Adoptive
Immunotherapy for Hodgkin Disease
Hodgkin Disease
Drug: gemcitabine; Drug: fludarabine; Drug:
melphalan; Drug: antithymocyte globulin;
Procedure: Allogeneic stem cell infusion; Drug:
tacrolimus; Drug: filgrastim (G-CSF); Drug:
methotrexate
TX
NCT00385788
20
9/17/2014 9:16:07 AM
LEUKEMIA /LYMPHOMA /MULTIPLE MYELOMA (CONTINUED)
Title
Cancer Type
Treatment
Location
NCT Number
Safety Study of CAT-8015 Immunotoxin in Patients With HCL
With Advance Disease
Leukemia, Hairy Cell Leukemia, HCL
Drug: Immunotoxin therapy; Drug: CAT-8015
immunotoxin; Procedure: Biological therapy
CA; IL; MD
NCT00462189
CNS Lymphoma
Brain and Central Nervous System
Tumors, Lymphoma, Lymphoproliferative
Disorder, Small Intestine Cancer
Biological: autologous immunoglobulin
TX
NCT00621036
Autologous and Allogeneic Transplant for
Relapsed Lymphoma
Non-Hodgkin Lymphoma,
Hodgkins Disease
Drug: fludarabine and busulfan; Drug:
fludarabine, busulfan and ATG
NY
NCT00802113
Neukoplast (NK-92) for the Treatment of Refractory or
Relapsed Acute Myeloid Leukemia
Acute Myeloid Leukemia
Biological: Neukoplast (NK-92)
PA
NCT00900809
Phase I Study of B Cell Malignancies Using T Cells
Expressing an Anti-CD19 Chimeric Receptor: Assessment of
the Impact of Lymphocyte Depletion Prior to T Cell Transfer
Chronic Lymphocytic Leukemia, Small
Lymphocytic Lymphoma, Mantle Cell
Lymphoma, Follicular Lymphoma, Large
Cell Lymphoma
Biological: Anti-CD19-CAR PBL
MD
NCT00924326
Safety and Efficacy Study of Immunotherapy With Rituximab
and Interleukin-2 in Patients With Non-Hodgkin Lymphoma
High Risk Non-Hodgkin Lymphoma
Biological: rituximab; Biological: interleukin-2
PA
NCT00994643
Administration of Anti-CD19-chimeric-antigen-receptortransduced T Cells From the Original Transplant Donor to
Patients With Recurrent or Persistent B cell Malignancies
After Allogeneic Stem Cell Transplantation
B Cell Leukemia, Hodgkin Lymphoma,
Non-Hodgkin Lymphoma, B Cell
Lymphoma
Procedure: Allogeneic stem cell
transplant; Biological: Anti-CD19-chimericantigen receptor-traduced T cell; Drug:
cyclophosphamide; Drug: pentostatin
MD
NCT01087294
Blockade of PD-1 in Conjunction With the Dendritic Cell/
AML Vaccine Following Chemotherapy Induced Remission
Acute Myelogenous Leukemia, AML
Biological: DC AML vaccine; Drug: CT-011
MA
NCT01096602
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/
Refractory, Aggressive NHL
Non-Hodgkin Lymphoma, NHL,
Aggressive NHL, Diffuse Large
B cell Lymphoma
Drug: veltuzumab and 90Y-epratuzumab
tetraxetan; Drug: 90Y-epratuzumab tetraxetan;
Drug: veltuzumab
DE; FL; IN; MN;
NY; PA
NCT01101581
A Phase II Study of Ofatumumab-Based Induction
Chemoimmunotheraphy Followed by Consolidation
Ofatumumab Immunotherapy in Previously Untreated
Patients With Chronic Lymphocytic Leukemia/Small
Lymphocytic Lymphoma
Small Lymphocytic Lymphoma, CLL
(Chronic Lymphocytic Leukemia)
Drug: fludarabine phosphate; Biological:
ofatumumab; Drug: cyclophosphamide
MD
NCT01145209
Immunotherapy for Asymptomatic Phase
Lymphoplasmacytic Lymphoma
Lymphoma
Biological: DNA Vaccine
TX
NCT01209871
Th1/Tc1 Immunotherapy Following Stem Cell
Transplantation in Multiple Myeloma
Multiple Myeloma
Procedure: Adoptive immunotherapy; Drug:
Th1/Tc1 product
MD; NJ
NCT01239368
Combination Immunotherapy and Autologous Stem Cell
Transplantation for Myeloma
Advanced Myeloma
Biological: Prevnar-pneumococcal conjugate
vaccine (PCV); Other: Activated/costimulated
autologous T cell; Drug: lenalidomide;
Biological: MAGE-A3, Hiltonol (Poly-ICLC)
MD; PA
NCT01245673
Trial of Daily Pulse Interleukin-2 With Famotidine in Acute
Myelogenous Leukemia
Acute Myelogenous Leukemia
Drug: interleukin-2
NC
NCT01289678
Trial of Low-Dose MTX and I 131 Tositumomab for Previously
Untreated, Advanced-Stage, Follicular Lymphoma
Follicular Lymphoma
Drug: Low-dose methotrexate and Bexxar
MI
NCT01389076
A Study of Brentuximab Vedotin in Relapsed or Refractory
Lymphoma, B-Cell, Lymphoma, Large
B-Cell, Diffuse, Lymphoma, NonHodgkin, Lymphoma, T-Cell
Drug: brentuximab vedotin; Drug: rituximab
AL; CA; CO; FL;
GA; IL; MA; MN;
MO; NJ; NV; NY;
OH; OR; SC; TX;
VA; WA
NCT01421667
Ofatumumab With or Without Bendamustine for Patients
With Mantle Cell Lymphoma Ineligible for Autologous Stem
Cell Transplant
Mantle Cell Lymphoma
Biological: ofatumumab; Other: ofatumumab +
bendamustine
NJ; NY
NCT01437709
Yttrium-90-labeled Daclizumab With Chemotherapy and
Stem Cell Transplant for Hodgkin s Lymphoma
Hodgkin Lymphoma
Radiation: 111In-daclizumab; Radiation:
90Y-daclizumab
MD
NCT01468311
Phase II Ofatumumab/Methylprednisolone Followed
by Ofatumumab/Lenalidomide for Untreated Chronic
Lymphocytic Leukemia/Small Lymphocytic Lymphoma
(CLL/SLL)
Chronic Lymphocytic Leukemia, Small
Drug: High-dose methylprednisolone (HDMP);
Drug: ofatumumab; Drug: lenalidomide
FL
NCT01496976
Immune Reconstitution in Oncology Patients Following
Autologous Stem Cell Transplant
Solid Tumor, Brain Tumor, Lymphoma
Other: Blood samples obtained
TN
NCT01540175
Continuous Infusion of rhIL-15 for Adults With
Advanced Cancer
Carcinoma, Lymphoma
Biological: rhIL-15
MD
NCT01572493
Phase I/II Study of hLL1-DOX in Relapsed NHL and CLL
Non-Hodgkin Lymphoma, Chronic
Lymphocytic Leukemia
Drug: hLL1-DOX (IMMU-115)
DE; FL; IN; MA;
NJ; TX
NCT01585688
Anti-CD19 White Blood Cells for Children and Young Adults
With B Cell Leukemia or Lymphoma
ALL, B Cell Lymphoma, Leukemia, Large
Cell Lymphoma, Non-Hodgkin Lymphoma
Biological: Anti-CD19-CAR
MD
NCT01593696
21
9/17/2014 9:16:07 AM
CLINICAL TRIALS
LEUKEMIA/LYMPHOMA/MULTIPLE MYELOMA
Title
Cancer Type
Treatment
Location
NCT Number
Laboratory-Treated T Cells in Treating Patients With HighRisk Relapsed Acute Myeloid Leukemia, Myelodysplastic
Syndrome, or Chronic Myelogenous Leukemia Previously
Treated With Donor Stem Cell Transplant
Biological: WT1-sensitized T cells;
Biological: aldesleukin; Other: laboratory
biomarker analysis
WA
NCT01640301
A Pediatric Trial of Genetically Modified Autologous
T Cells Directed Against CD19 for Relapsed CD19+ Acute
Lymphoblastic Leukemia
B Cell Leukemia
Biological: Autologous CD19 CAR+ EGFTt +
T cells
WA
NCT01683279
Study of Infusion of Blood Cells (Lymphocytes) to Stimulate
the Immune System to Fight Leukemia/Lymphoma
Mantle Cell Lymphoma, Diffuse Large
Cell Lymphoma, Burkitts Lymphoma,
T Cell Lymphomas, Acute Myeloid
Leukemia/Acute Lymphoblastic
Leukemia
Biological: Cellular immunotherapy
RI
NCT01685606
Therapy for Pediatric Relapsed or Refractory Precursor
B-Cell Acute Lymphoblastic Leukemia and Lymphoma
Recurrent Childhood Acute
B-lymphoblastic Leukemia, Recurrent
Childhood B-lymphoblastic Lymphoma
Drug: dexamethasone; Drug: vincristine
sulfate; Biological: rituximab; Drug:
clofarabine; Drug: cyclophosphamide;
Drug: etoposide; Biological: aldesleukin;
Drug: pegaspargase; Drug: methotrexate;
Drug: mercaptopurine; Drug: cytarabine;
Drug: mitoxantrone; Drug: teniposide;
Drug: vinblastine; Biological: Natural killer
cell infusion; Other: Laboratory biomarker
analysis; Drug: Therapeutic hydrocortisone;
Procedure: Allogeneic hematopoietic stem cell
transplantation
TN
NCT01700946
Phase III Frontline Therapy Trial in Patients With Advanced
Classical Hodgkin Lymphoma
Hodgkin Lymphoma
Drug: brentuximab vedotin; Drug: doxorubicin;
Drug: bleomycin; Drug: vinblastine; Drug:
dacarbazine
AL; AZ; CA; CO;
DC; FL; IL; IN; MA;
MD; MI; MN; MO;
NC; ND; NE; NJ;
NM; NV; NY; OH;
PA; SC; TN; TX; UT;
WA; WI; WV
NCT01712490
A Study of Brentuximab Vedotin in Adults Age 60 and Above
With Newly Diagnosed Hodgkin Lymphoma (HL)
Hodgkin Disease
Drug: brentuximab vedotin; Drug: dacarbazine
AL; AZ; CA; CO;
FL; GA; IL; MD;
NE; NY; OR; TX;
VA; WA
NCT01716806
Phase I Dose Escalation Study of IMMU-114 in Relapsed or
Refractory NHL and CLL
Non-Hodgkin Lymphoma, Follicular
Lymphoma, Mantle Cell Lymphoma,
Marginal Zone Lymphoma, Chronic
Lymphocytic Leukemia, Small
Drug: IMMU-114
OH
NCT01728207
ECHELON-2: A Comparison of Brentuximab Vedotin and CHP
With Standard-of-care CHOP in the Treatment of Patients
With CD30-positive Mature T cell Lymphomas
Large-Cell Anaplastic Lymphoma,
Non-Hodgkin Lymphoma, T Cell
Lymphoma
Drug: brentuximab vedotin; Drug: doxorubicin;
Drug: prednisone; Drug: vincristine;
AL; CA; CT; FL; IA;
KS; MA; MD; MI;
MN; MO; NJ; NY;
OH; OK; PA; TN;
TX; VA; WA
NCT01777152
Autologous T-Lymphocytes Genetically Targeted to
the B-Cell Specific Antigen CD19 in Pediatric and
Young Adult Patients With Relapsed B-Cell Acute
Relapsed B-Cell Acute
Procedure: Leukapheresis or collection of
PBMCs; Drug: cyclophosphamide;
Biological: Modified T cells
MA; NY
NCT01860937
Laboratory Treated T Cells in Treating Patients With
Relapsed or Refractory Chronic Lymphocytic Leukemia,
Non-Hodgkin Lymphoma, or Acute Lymphoblastic Leukemia
Biological: Anti-CD19-CAR lentiviral vectortransduced autologous T lymphocytes;
WA
NCT01865617
Allogeneic Stem Cell Transplantation With Adoptive
Immunotherapy in Epstein-Barr Virus Positive Recurrent/
Refractory Hodgkin Lymphoma
Hodgkin Lymphoma
Biological: Allogeneic donor-derived LMPspecific cytotoxic T-lymphocyte
NY
NCT01636388
Study of Brentuximab Vedotin Combined With
Bendamustine in Patients With Hodgkin Lymphoma
Hodgkin Disease
Drug: brentuximab vedotin; Drug:
bendamustine
AL; CA; CO; IL;
IN; MA; MI; MN;
NE; NY; OH; SC;
TX; VA
NCT01874054
Safety Study of CAT-8015 Immunotoxin in Patients With CLL,
PLL or SLL With Advance Disease
Leukemia
Drug: Immunotoxin therapy; Drug: CAT-8015
immunotoxin; Procedure: Biological therapy
CA; IL, MD
NCT00457860
Collect Long-term Data on Subjects Following Participation
in Previous EMD 531444 (L-BLP25 or BLP25 Liposome
Vaccine) Clinical Trials
Multiple Myeloma
Biological: tecemotide; Other: No intervention
MA
NCT01423760
22
9/17/2014 9:16:07 AM
Title
Cancer Type
Treatment
Location
NCT Number
A Safety Study of SGN-CD33A in AML Patients
Acute Myelogenous Leukemia, Acute
Myeloid Leukemia
Drug: SGN-CD33A
AL; CA; FL; MA;
NY; OH; UT; WA
NCT01902329
Study of Brentuximab Vedotin Combined With RCHOP in
Front-line Treatment of Patients With Diffuse Large B cell
Lymphoma (DLBCL)
B Cell Lymphoma, Diffuse Large B Cell
Lymphoma
Drug: brentuximab vedotin; Drug: rituximab;
Drug: vincristine; Drug: cyclophosphamide;
Drug: prednisone; Drug: doxorubicin
AZ; CA; CO; MN;
MO; NJ; OH; OR;
TX; UT; VA; WA
NCT01925612
Cellular Immunotherapy Treatment Antigen-Directed for
EBV Lymphoma
EBV Extranodal NK-T-Cell Lymphoma
Biological: CMD-003
CA; DC; MA; MN;
NJ; NY; OH; OR;
PA; TN; TX
NCT01948180
A Pediatric and Young Adult Trial of Genetically Modified
T Cells Directed Against CD19 for Relapsed/Refractory
CD19+ Leukemia
CD19+ Leukemia
Biological: Patient-derived CD19 specific CAR
T cells also expressing an EGFRt
WA
NCT02028455
Central Memory Enriched T Cells Following Stem Cell
Transplant in Treating Patients With Recurrent B-Cell
Biological: autologous CD19CAR-CD28CD3zeta-EGFRt-expressing Tcm-enriched T
cells; Other: Laboratory biomarker analysis
CA
NCT02051257
Immunotherapy Following Reduced Intensity Conditioning
and Allogeneic Stem Cell Transplant for Poor Risk CD30+
Hodgkin Lymphoma Patients
Hodgkin Lymphoma
Drug: brentuximab vedotin; Procedure:
Allogeneic stem cell transplantation; Drug:
Reduced intensity conditioning
NY
NCT02098512
A Study of ALT-803 in Patients With Relapsed or Refractory
Multiple Myeloma
Relapsed or Refractory
Multiple Myeloma
Biological: ALT-803
MN
NCT02099539
A Pilot Study of Immunotherapy Including Haploidentical
NK Cell Infusion Following CD133+ Positively-Selected
Autologous Hematopoietic Stem Cells in Children With High
Risk Solid Tumors or Lymphomas
Neuroblastoma, Lymphoma,
High-risk Tumor
Device: CD133+ selected autologous stem
cell infusion; Biological: IL-2; Biological:
hu14.18K322A; Drug: busulfan; Drug:
melphalan; Biological: GM-CSF; Drug:
carmustine; Drug: etoposide; Drug: cytarabine;
Drug: carboplatin; Device: Haploidentical
natural killer cell infusion; Biological: G-CSF;
Drug: etoposide phosphate
TN
NCT02130869
Cellular Immunotherapy After Cyclophosphamide in Treating
Patients With High-Risk Acute Lymphoblastic Leukemia
B cell Adult Acute Lymphoblastic
Leukemia, Recurrent Adult Acute
Drug: cyclophosphamide; Biological:
autologous CD19CAR-CD28-CD3zeta-EGFRtexpressing Tcm-enriched T cells; Other:
Laboratory biomarker analysis
CA
NCT02146924
Cellular Immunotherapy Following Cyclophosphamide
in Treating Patients With Recurrent Non-Hodgkin
Lymphomas, Chronic Lymphocytic Leukemia or B-Cell
Prolymphocytic Leukemia
Post-transplant Lymphoproliferative
Disorder, Prolymphocytic Leukemia,
Recurrent Adult Burkitt Lymphoma,
Recurrent Adult Diffuse Large Cell
Lymphoma, Recurrent Grade 1 Follicular
Lymphoma, Recurrent Mantle Cell
Lymphoma, Recurrent Marginal Zone
Lymphoma, Recurrent Small Lymphocytic
Lymphoma, Refractory Chronic
Lymphocytic Leukemia, Refractory
Hairy Cell Leukemia, Waldenström
Macroglobulinemia
Drug: cyclophosphamide; Biological:
Autologous CD19CAR-CD28-CD3zeta-EGFRtexpressing Tcm-enriched T cells;
CA
NCT02153580
A Phase Ib/II Study of IPI-145 Plus FCR in Previously
Untreated, Younger Patients With CLL
Chronic Lymphocytic Leukemia
Drug: IPI-145; Drug: fludarabine; Drug:
cyclophosphamide; Drug: rituximab
MA
NCT02158091
Genetically Modified T cell Immunotherapy in
Treating Patients With Relapsed or Refractory
Acute Myeloid Leukemia
Adult Acute Megakaryoblastic
Leukemia (M7), Adult Acute Minimally
Differentiated Myeloid Leukemia (M0),
Adult Acute Monoblastic Leukemia
(M5a), Adult Acute Monocytic Leukemia
(M5b), Adult Acute Myeloblastic
Leukemia With Maturation (M2),
Adult Acute Myeloblastic Leukemia
Without Maturation (M1), Adult Acute
Myeloid Leukemia With 11q23 (MLL)
Abnormalities, Adult Acute Myeloid
Leukemia With Del(5q), Adult Acute
Myeloid Leukemia With Inv(16)(p13;q22),
Adult Acute Myeloid Leukemia With
t(16;16)(p13;q22), Adult Acute Myeloid
Leukemia With t(8;21)(q22;q22), Adult
Acute Myelomonocytic Leukemia (M4),
Adult Erythroleukemia (M6a), Adult Pure
Erythroid Leukemia (M6b), Recurrent
Adult Acute Myeloid Leukemia
Drug: cyclophosphamide; Biological: AntiCD123-CAR/CD28-costimulatory, retroviral
vector-transduced autologous T lymphocytes;
CA
NCT02159495
Micro Needle Array-Doxorubicin (MNA-D) in Patients With
Cutaneous T cell Lymphoma (CTCL)
Cutaneous T Cell Lymphoma
Drug: Micro needle array-doxorubicin
(MNA-D)
PA
NCT02192021
Study of T Cells Targeting B-Cell Maturation Antigen for
Previously Treated Multiple Myeloma
Plasma-Cell Myeloma, Multiple
Myeloma
Drug: cyclophosphamide; Drug: fludarabine;
Biological: Anti-BCMA CAR T cells
MD
NCT02215967
23
9/17/2014 9:16:07 AM
CLINICAL TRIALS
LIVER - MELANOMA
LIVER
Title
Cancer Type
Tract Cancers
Cholangiocarcinoma
Title
Cancer Type
Treatment
Location
NCT Number
MD
NCT00034216
MD
NCT01174121
Treatment
Location
NCT Number
Bladder Cancer
MD
NCT00001823
MD
NCT00034216
Laboratory-Treated Autologous Lymphocytes, Aldesleukin,
and GM-CSF in Treating Patients With Recurrent, Refractory,
or Metastatic Non-Small Cell Lung Cancer
Lung Cancer
Biological: EGFRBi-armed autologous
activated T cells; Biological: aldesleukin;
Biological: sargramostim
RI
NCT00569296
Expression Analysis of Specific Markers in Non-Small Cell
Lung Cancer or Melanoma
Non-Small Cell Lung Cancer
Procedure: Collection of tumor and
blood samples
CA; IL; MO; UT
NCT00685750
Metronomic Oral Cyclophosphamide and Celecoxib
in Patients Undergoing Resection of Lung and
Esophageal Cancers, Thymic Neoplasms, and Malignant
Pleural Mesotheliomas
Biological: Allogeneic tumor cell
vaccine (K562); Drug: celecoxib;
MD
NCT01143545
Drug: fludarabine
MD
NCT01218867
Randomized Study of Adjuvant WT-1 Analog Peptide
Vaccine in Patients With Malignant Pleural Mesothelioma
(MPM) After Completion of Combined Modality Therapy
Malignant Pleural Mesothelioma
Biological: WT-1-vaccine Montanide +
GM-CSF; Biological: Montanide adjuvant +
GM-CSF
NY
NCT01265433
Phase IIB/III Of TG4010 Immunotherapy In Patients With
Stage IV Non-Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Biological: TG4010; Drug: Placebo
AZ; KS; KY; MD;
MO; NC; OH;
PA; TX
NCT01383148
Combination Immunotherapy of GM.CD40L Vaccine With
CCL21 in Lung Cancer
Lung Cancer, Adenocarcinoma
Biological: GM.CD40L.CCL21 vaccinations;
Biological: GM.CD40L cells vaccinations
FL
NCT01433172
Combination Vaccine Immunotherapy (DRibbles) for
Patients With Definitively-Treated Stage III Non-Small Cell
Lung Cancer
Non-Small Cell Lung Cancer Carcinoma
Drug: cyclophosphamide; Biological: DRibble
vaccine; Drug: imiquimod; Drug: GM-CSF;
Biological: HPV vaccine
OR
NCT01909752
Radiation: PET/CT imaging with [18F]
2-deoxy-2-(18F)fluoro-D-glucose (FDG)
MD
NCT01666353
Safety and Efficacy of Listeria in Combination With
Chemotherapy as Front-line Treatment for Malignant
Pleural Mesothelioma
Biological: Vaccine plus chemotherapy
CA; FL; IL; MD; PA
NCT01675765
Biological: Recombinant interleukin-15;
Other: Pharmacological study;
CA; MD; MN;
WA; WI
NCT01727076
Immunotherapy Study in Progressive or Relapsed Non-Small
Cell Lung Cancer
Non-Small Cell Lung Cancer, Progression
of Non-Small Cell Lung Cancer,
Non-Small Cell Lung Cancer Recurrent
Drug: docetaxel; Biological: HyperAcute-Lung
Immunotherapy; Drug: gemcitabine;
Drug: pemetrexed
CA; CT; FL; IL;
IN; KS; MO; MS;
NE; NY; OH; TN;
VA; WI
NCT01774578
Combination of gp96-Ig Vaccine, Theophylline and Oxygen
for the Treatment of Patients With Advanced, Relapsed or
Metastatic Non-Small Cell Lung Cancer
Biological: gp96-Ig vaccine;
Drug: theophylline; Other: Oxygen;
Procedure: Immunologic evaluation
FL
NCT01799161
A Study to Demonstrate the Benefit of a New Kind of
Anti-cancer Treatment [Preferentially Expressed Antigen
of Melanoma (PRAME) Immunotherapy] for Patients With
Non-Small Cell Lung Cancer (NSCLC), After Removal of
Their Tumor
Non-Small Cell Lung Cancer
Biological: Recombinant PRAME protein
combined with the AS15 Adjuvant System
GSK2302032A; Biological: Placebo
DE; IL; MN; NJ;
NY; PA; WA
NCT01853878
Phase II Study of Adjuvant WT-1 Analog Peptide Vaccine in
MPM Patients After MSK10-134
Biological: WT-1-vaccine Montanide +
GM-CSF; Biological: Montanide adjuvant +
GM-CSF
NY; TX
NCT01890980
LUNG
24
9/17/2014 9:16:08 AM
LUNG (CONTINUED)
Title
Cancer Type
Treatment
Location
NCT Number
Pleural Effusion
Malignant Pleural Effusion,
Lung Cancer, Mesothelioma,
Breast Cancer, Ovarian Cancer
PA
NCT01997190
A Phase Ib Study of MEDI4736 in Combination With
Tremelimumab in Subjects With Advanced Non-Small Cell
Lung Cancer
NSCLC, Non-Small Cell Lung Cancer,
Lung Cancer
Drug: MEDI4736; Drug: tremelimumab
CA; CT; FL; NY
NCT02000947
Breast Cancer
AZ; FL; MI; NY
NCT02015416
A Study of Pembrolizumab (MK-3475) in Combination With
Chemotherapy or Immunotherapy in Participants With Lung
Cancer (MK-3475-021/KEYNOTE-021)
Drug: pembrolizumab; Drug: paclitaxel; Drug:
carboplatin; Biological: bevacizumab; Drug:
pemetrexed; Biological: ipilimumab; Drug:
erlotinib; Drug: gefitinib
MI; OH; PA; TX
NCT02039674
Biological: H1299 lysate vaccine; Drug:
cyclophosphamide; Drug: celecoxib
MD
NCT02054104
A Phase II Study of Viagenpumatucel-L (HS-110) in Patients
With Non-Small Cell Lung Cancer
Non Small Cell Lung Cancer
Drug: viagenpumatucel-L; Drug: metronomic
cyclophosphamide; Drug: Physician’s Choice
Regimen (vinorelbine, erlotinib, gemcitabine;
paclitaxel, docetaxel)
CA; MA; MO; OH;
PA; TX
NCT02117024
Expressing NY-ESO-1
CT; MA; MN;
TX; WA
NCT02122861
Lung Cancer, Breast Cancer, Prostate
Cancer, Tumors (Others)
MD
NCT02179515
Study of Combined Ionizing Radiation and Ipilimumab in
Metastatic Non-Small Cell Lung Cancer (NSCLC)
Drug: ipilimumab; Radiation: Radiotherapy
(IMRT)
NY
NCT02221739
Collect Long-term Data on Subjects Following Participation
in Previous EMD 531444 (L-BLP25 or BLP25 Liposome
Vaccine) Clinical Trials
Multiple Myeloma
Biological: tecemotide; Other: No intervention
MA
NCT01423760
Title
Cancer Type
Treatment
Location
NCT Number
Bladder Cancer
MD
NCT00001823
Multiple Class I Peptides & Montanide ISA 51 VG w
Escalating Doses of Anti-PD-1 Antibody BMS936558
Melanoma (Skin)
Biological: NY-ESO-1; Biological: BMS936558; Biological: gp100:280-288(288V);
Drug: montanide
FL
NCT01176474
Drug: fludarabine
MD
NCT01218867
Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy
After Tumor Removal
Sarcoma, Melanoma, Epithelial
Malignancies, Pleural Malignancy
Biological: Epigenetically modified autologous
tumor; Drug: cyclophosphamide;
Drug: celecoxib
MD
NCT01341496
RADVAX: A Stratified Phase I/II Dose Escalation Trial of
Stereotactic Body Radiotherapy Followed by Ipilimumab in
Metastatic Melanoma
Metastatic Melanoma
Drug: ipilimumab; Radiation: Stereotactic body
radiation therapy
PA
NCT01497808
Vemurafenib and White Blood Cell Therapy for
Advanced Melanoma
Metastatic Cancer, Melanoma
Drug: vemurafenib; Drug: Young TIL;
Drug: aldesleukin
MD
NCT01585415
Vemurafenib With Lymphodepletion Plus Adoptive Cell
Transfer & High Dose IL-2 Metastatic Melanoma
Metastatic Melanoma
Drug: High-dose interleukin-2 (IL-2); Procedure:
ACT with TIL infusion; Drug: vemurafenib;
Drug: Lymphodepletion
FL
NCT01659151
Radiation: PET/CT imaging with [18F] 2-deoxy2-(18F)fluoro-D-glucose (FDG)
MD
NCT01666353
HD IL-2 + Vemurafenib in Patients With BRAF Mutation
Positive Metastatic Melanoma
Metastatic Melanoma
Drug: vemurafenib + HD IL-2
AZ; CA; FL; GA; IA;
IL; IN; LA; MI; MN;
NH; NJ; NY; OH;
OR; PA
NCT01683188
Phase II Randomized Trial of Ipilimumab Versus Ipilimumab
and Radiotherapy in Metastatic Melanoma
Metastatic Melanoma
Drug: ipilimumab; Other: Radiation therapy
and ipilimumab
NY
NCT01689974
Biological: Recombinant interleukin-15; Other:
Pharmacological study; Other: Laboratory
biomarker analysis
CA; MD; MN;
WA; WI
NCT01727076
Treatment of Advanced Melanoma With MK-3475 and
Peginterferon
Melanoma
Drug: MK-3475;
Drug: peginterferon alfa-2b
PA
NCT02112032
MELANOMA
25
9/17/2014 9:16:08 AM
CLINICAL TRIALS
MELANOMA - OVARIAN
MELANOMA (CONTINUED)
Title
Cancer Type
Treatment
Location
Ipilimumab With or Without Talimogene Laherparepvec in
Unresected Melanoma
Melanoma
Drug: talimogene laherparepvec plus
ipilimumab; Drug: ipilimumab
AZ; CA; FL; IA; IL; IN; NCT01740297
KY; MN; NC; NJ; NY;
OH; TN; UT
NCT Number
Dendritic Cell Activating Scaffold in Melanoma
Melanoma
Biological: WDVAX
MA
NCT01753089
Combined BRAF-Targeted Therapy & Immunotherapy
for Melanoma
Melanoma
Drug: vemurafenib; Drug: aldesleukin
MA
NCT01754376
Detection of Immune Cell Infiltration Into Melanomas
Treated by PV-10, a Feasibility Study
Melanoma
Drug: PV-10; Procedure: Surgery
FL
NCT01760499
Study Comparing the Efficacy of MEK162 Versus
Dacarbazine in Unresectable or Metastatic NRAS Mutationpositive Melanoma
Metastatic or Unresectable
Cutaneous Melanoma
Drug: MEK162; Drug: dacarbazine
AL; AR; CA; CO;
DC; FL; IA; IL; IN;
MA; MD; ME;
MI; MN; MO; NC;
NE; NH; NJ; NV;
NY; OH; OR; PA;
TN; TX
NCT01763164
Aldesleukin Imaging in Viewing Tumor Growth in Patients
With Stage IV Melanoma Receiving Ipilimumab Therapy
Recurrent Melanoma,
Stage IV Melanoma
Procedure: Scintigraphy; Other: Laboratory
biomarker analysis; Biological: Technetium
Tc 99 hydrazinonicotinamide-tricine-linked
interleukin-2
MN
NCT01789827
Tumor-Infiltrating Lymphocytes After Combination
Chemotherapy in Treating Patients With
Metastatic Melanoma
Recurrent Melanoma, Stage IIIA
Melanoma, Stage IIIB Melanoma, Stage
IIIC Melanoma, Stage IV Melanoma
phosphate; Biological: Therapeutic tumor
infiltrating lymphocytes; Biological:
aldesleukin; Other: Laboratory biomarker
analysis
WA
NCT01807182
NY-ESO-1 Vaccine in Combination With Ipilimumab in
Patients With Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma
Biological: ipilimumab; Biological: NY-ESO-1
protein vaccine; Biological: NY-ESO-1
OLP4 vaccine
NY; PA; VA
NCT01810016
The Effects of Vemurafenib on Immunity in Patients
With Melanoma
Melanoma
Drug: vemurafenib
DC
NCT01813214
Autologous Dendritic Cell-Tumor Cell Immunotherapy for
Metastatic Melanoma
Stage IV Melanoma, Stage III Melanoma
Biological: Autologous dendritic cell-tumor
cell immunotherapy (DC-TC); Biological:
Autologous PBMCs in GM-CSF (MC)
CA
NCT01875653
Dendritic Cell Vaccines + Dasatinib for
Metastatic Melanoma
Metastatic Melanoma
Biological: DC vaccine; Drug: dasatinib
PA
NCT01876212
INCB024360 and Vaccine Therapy in Treating Patients
With Stage III-IV Melanoma
Drug: IDO1 inhibitor INCB024360; Biological:
MELITAC 12.1 peptide vaccine; Other:
GA; NC; NH; VA
NCT01961115
Breast Cancer
AZ; FL; MI; NY
NCT02015416
Cellular Adoptive Immunotherapy Using Autologous CD8+
Antigen-Specific T Cells and Anti-CTLA4
Melanoma
Drug: cyclophosphamide; Procedure: CD8+ T
cells; Drug: interleukin-2; Drug: ipilimumab
TX
NCT02027935
Vemurafenib:Radiation Use During Vemurafenib Treatment
Melanoma
Drug: vemurafenib
UT
NCT02042040
Immunotherapy Study for Patients With Stage IV Melanoma
Stage IV Melanoma,
Metastatic Melanoma
Drug: HyperAcute-Melanoma (HAM)
immunotherapy; Drug: ipilimumab
NC; TN
NCT02054520
Phase II Study of CD62L+-Derived T Lymphocytes
Transduced With a T Cell Receptor Recognizing the NYESO-1 Antigen and Aldesleukin Following Lymphodepletion
in Patients With NY-ESO-1 Expressing Melanoma
Metastatic Cancer,
Metastatic Melanoma
Biological: Anti-NY ESO-1 TCR CD62L+ cells;
Drug: aldesleukin; Drug: cyclophosphamide;
Drug: fludarabine
MD
NCT02062359
Study of IDO Inhibitor in Combination With Ipilimumab for
Adult Patients With Metastatic Melanoma
Metastatic Melanoma, Stage III
Melanoma, Stage IV Melanoma
Drug: indoximod; Drug: ipilimumab
GA; NC; NH; VA
NCT02073123
Study of Cell Transfer Therapy for Metastatic Melanoma
Using 4-1BB Tumor Infiltrating Lymphocytes Plus IL-2
Following a Non-Myeloablative Lymphocyte Depleting
Chemotherapy
Melanoma, Skin Cancer
Drug: interleukin-2; Drug: fludarabine; Drug:
cylcophosphamide; Genetic: 41BB selected
tumor infiltrating lymphocytes
MD
NCT02111863
Safety and Efficacy Study of Vemurafenib and High-dose
Interferon Alfa-2b in Melanoma
Melanoma
Drug: High-dose interferon alfa-2b;
Drug: vemurafenib
PA
NCT01943422
Expressing NY-ESO-1
CT; MA; MN;
TX; WA
NCT02122861
CDX-1401 and Poly-ICLC Vaccine Therapy With or Without
CDX-301 in Treating Patients With Stage IIB-IV Melanoma
Biological: recombinant flt3 ligand; Biological:
DEC-205/NY-ESO-1 fusion protein CDX-1401;
Biological: neoantigen-based Melanoma-polyICLC vaccine; Other: laboratory biomarker
analysis; Other: pharmacological study
NH; NY
NCT02129075
26
9/17/2014 9:16:08 AM
MELANOMA (CONTINUED)
Title
Cancer Type
Treatment
Location
NCT Number
Adoptive Therapy Using Antigen-Specific CD4 T-Cells
Melanoma, Sarcoma
Drug: ipilimumab; Drug: cyclophosphamide;
Biological: CD4+ T cells
TX
NCT02210104
Multiple Antigen-Engineered DC Vaccine for Melanoma
Melanoma
Biological: DC Vaccine + IFN;
Biological: AdVTMM2/DC vaccination
PA
NCT01622933
Neoadjuvant Combination Therapy With Ipilimumab and
HighDose IFN-a2b for Melanoma
Melanoma
Drug: Administration of ipilimumab10mg/kg;
Drug: Administration of ipilimumab 3mg/
kg + HDI
PA
NCT01608594
Aldesleukin With or Without Ziv-Aflibercept in Treating
Patients With Stage III-IV Melanoma That Cannot Be
Removed By Surger
Recurrent Melanoma
Stage III-IV Melanoma
Biological: ziv-aflibercept;
Biological: aldesleukin;
CA, CO, GA, IL, IN,
MI, MN, NH, NY,
OH, PA, TN, VA
NCT01258855
Title
Cancer Type
Treatment
Location
NCT Number
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for
Primary Refractory Neuroblastoma in Bone Marrow
Neuroblastoma
Biological: 3F8/GM-CSF immunotherapy plus
13-Cis-Retinoic acid
NY
NCT01183897
Pilot Study of Zoledronic Acid and Interleukin-2 for
Refractory Pediatric Neuroblastoma
Neuroblastoma
Drug: zoledronic acid; Biological: aldesleukin
AL
NCT01404702
Study of Donor Derived, Multi-virus-specific, Cytotoxic
T-Lymphocytes for Relapsed/Refractory Neuroblastoma
Neuroblastoma
Biological: Tri-virus specific cytotoxic T cells
MO
NCT01460901
Viral Oncoprotein Targeted Autologous T Cell Therapy for
Merkel Cell Carcinoma
Recurrent Neuroendocrine Carcinoma
of the Skin, Stage IV Neuroendocrine
Carcinoma of the Skin
Radiation: Radiation therapy;
Biological: Recombinant interferon beta;
Biological: MCPyV TAg-specific polyclonal
autologous CD8-positive T cell vaccine;
Biological: aldesleukin; Other: Laboratory
biomarker analysis
WA
NCT01758458
3rd Generation GD-2 Chimeric Antigen Receptor and
iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN
Neuroblastoma
Genetic: iC9-GD2 T cell lymphocytes
TX
NCT01822652
Phase II STIR Trial: Haploidentical Transplant and Donor
Natural Killer Cells for Solid Tumors
Ewing Sarcoma, Neuroblastoma,
Rhabdomyosarcoma
Procedure: Allogeneic HCT; Drug: Donor NK
cell infusion
WI
NCT02100891
Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for HighRisk Neuroblastoma
Neuroblastoma
Biological: Anti-GD2 3F8 monoclonal antibody;
Drug: GM-CSF (granulocyte-macrophage
colony-stimulating factor);
Drug: oral isotretinoin
NY
NCT02100930
Activated T Cells Armed With GD2 Bispecific Antibody
in Children and Young Adults With Neuroblastoma
and Osteosarcoma
Biological: aldesleukin; Biological: OKT3/
humanized 3F8 bispecific antibody-activated T
lymphocytes; Biological: sargramostim; Other:
MI; NY
NCT02173093
Isotretinoin With or Without Monoclonal Antibody Ch14.18,
Aldesleukin, and Sargramostim Following Stem Cell
Transplant in Treating Patients With Neuroblastoma
Disseminated Neuroblastoma|Localized
Resectable Neuroblastoma|Localized
Unresectable Neuroblastoma|Regional
Neuroblastoma|Stage 4S Neuroblastoma
Drug: isotretinoin|Biological:
sargramostim|Biological:
dinutuximab|Biological: aldesleukin|Other:
laboratory biomarker analysis|Other: qualityof-life assessment|Other: pharmacological
study
AL; AR; AZ; CA; CO; NCT00026312
CT; DC; DE; FL; GA;
HI; IA; IL; IN; KY; LA;
MA; MD; ME; MI;
MN; MO; MS; NC;
ND; NE; NH; NJ;
NM; NV; NY; OH;
OK; OR; PA; RI; SC;
SD; TN; TX; UT; VA;
VT; WA; WI; WV
Consolidation of First Remission After Non-Myeloablative
Therapy in Patients With High-Risk Neuroblastoma
Neuroblastoma
Drug: 3F8 and 13-cis-retinoic acid
NY
NCT01183429
Consolidation of Second or Greater Remission of High-Risk
Neuroblastoma
Neuroblastoma
Biological: 3F8/GM-CSF Immunotherapy Plus
13-Cis-Retinoic Acid
NY
NCT01183897
Title
Cancer Type
Treatment
Location
NCT Number
Trial of Adjuvant FANG Vaccine for High Risk Stage III/IV
Ovarian Cancer
Ovarian Cancer
Biological: FANG
FL; NH; TX; WA
NCT01309230
Solid Tumors
Malignant Solid Tumour, Breast Cancer,
Ovarian Cancer
OH
NCT01376505
Safety Study of ²¹²Pb-TCMC-Trastuzumab
Radio Immunotherapy
Pancreatic Neoplasms, Stomach
Neoplasms
Other: ²¹²Pb-TCMC-trastuzumab;
AL; CA
NCT01384253
Treating Cancer With Anti-mesothelin
Modified Lymphocytes
Metastatic Cancer, Pancreatic Cancer,
Mesothelioma, Ovarian
Drug: fludarabine; Biological: anti-mesothelin
CAR; Drug: cyclophosphamide;
Drug: aldesleukin
MD
NCT01583686
NEUROENDOCRINE
OVARIAN
27
9/17/2014 9:16:08 AM
CLINICAL TRIALS
OVARIAN - PROSTATE
OVARIAN (CONTINUED)
Title
Cancer Type
Treatment
Location
NCT Number
How Our Immune System Can Help Fight Cancer
Ovarian Cancer
Drug: carboplatin & paclitaxel; Biological:
carboplatin & paclitaxel & oregovomab
CT; IN
NCT01616303
Metastatic Cancer|Metastatic
Melanoma|Renal Cancer|Colorectal
Cancer|Ovarian Cancer|Lung Cancer
Genetic: Anti-VEGFR2 CAR CD8 plus PBL|Drug:
Cyclophosphamide|Drug: Aldesleukin|Drug:
Fludarabine
MD
NCT01218867
A Maintenance Study With Niraparib Versus Placebo in
Patients With Platinum Sensitive Ovarian Cancer
Platinum Sensitive Ovarian Cancer
Drug: Active comparator: Niraparib|Drug:
placebo
CT; IN
NCT01616303
Autologous Dendritic Cell-Tumor Cell Immunotherapy for
Advanced Epithelial Ovarian Carcinomas
Stage III Ovarian Carcinoma,
Stage IV Ovarian Carcinoma,
Fallopian Tube Carcinoma,
Primary Peritoneal Carcinoma
Biological: ovapuldencel-T; Biological: MC:
Autologous PBMCs in GM-CSF
CA
NCT02033616
A Maintenance Study With Niraparib Versus Placebo in
Patients With Platinum Sensitive Ovarian Cancer
Platinum Sensitive Ovarian Cancer
Drug: Active comparator: Niraparib|Drug:
placebo
AZ; CA; CT; FL; GA;
IL; IN; MA; MN;
NC; NJ; NM; NY;
OH; OK; PA; RI; TN;
TX; WA
NCT01847274
Pleural Effusion
Malignant Pleural Effusion, Lung Cancer,
Mesothelioma, Breast Cancer,
Ovarian Cancer
PA
NCT01997190
A Controlled Study of the Effectiveness of Oregovomab
(Antibody) Plus Chemotherapy in Advanced Ovarian Cancer
Ovarian Neoplasms
Drug: carboplatin & paclitaxel; Biological:
carboplatin & paclitaxel & oregovomab
CT; IN
NCT01616303
MN; NY
NCT02042430
Expressing NY-ESO-1
Non-Small Cell Lung Cancer, Ovarian
Cancer, Sarcoma
CT; MA; MN;
TX; WA
NCT02122861
Title
Cancer Type
Treatment
Location
NCT Number
Tract Cancers
Cholangiocarcinoma
MD
NCT01174121
Radio Immunotherapy
Pancreatic Neoplasms,
Stomach Neoplasms
AL; CA
NCT01384253
ATC infusions
MI
NCT01420874
Treating Cancer With Anti-Mesothelin
Modified Lymphocytes
Metastatic Cancer, Pancreatic Cancer,
Mesothelioma, Ovarian
Drug: fludarabine; Biological: Antimesothelin CAR; Drug: cyclophosphamide;
Drug: aldesleukin
MD
NCT01583686
Pancreatic Tumor Cell Vaccine (GVAX), Low Dose
Cyclophosphamide, Fractionated Stereotactic Body
Radiation Therapy (SBRT), and FOLFIRINOX Chemotherapy
in Patients With Resected Adenocarcinoma of the Pancreas
Pancreatic Cancer
Drug: cyclophosphamide; Biological: PANC
10.05 pcDNA-1/GM-Neo and PANC 6.03
pcDNA-1/GM-Neo vaccine; Radiation:
Stereotactic body radiation (SBRT); Drug:
FOLFIRINOX
MD
NCT01595321
Immunotherapy Study in Borderline Resectable or Locally
Advanced Unresectable Pancreatic Cancer
Pancreatic Cancer, Pancreatic Carcinoma
Non-resectable, Locally Advanced
Malignant Neoplasm
Drug: FOLFIRINOX; Biological: algenpantucel-L
immunotherapy; Radiation: 5-FU
chemoradiation; Drug: gemcitabine;
Drug: capecitabine; Drug: nab-paclitaxel
AZ; CA; CT; FL; IL;
IN; KS; MI; MN;
NC; NY; OH; OK;
OR; PA; TN; TX;
WA; WI
NCT01836432
A Phase II, Multicenter Study of FOLFIRINOX Followed
by Ipilimumab With Allogenic GM-CSF Transfected
Pancreatic Tumor Vaccine in the Treatment of Metastatic
Pancreatic Cancer
Metastatic Pancreatic Adenocarcinoma
Drug: ipilimumab; Biological: Vaccine;
Drug: FOLFIRINOX
MD
NCT01896869
Chemoimmunotherapy and Radiation in Pancreatic Cancer
Locally Advanced Malignant Neoplasm
Drug: tadalafil; Drug: gemcitabine;
Radiation: Radiation; Procedure:
Pancreaticoduodenectomy
OR
NCT01903083
PANCREATIC
28
9/17/2014 9:16:09 AM
PANCREATIC (CONTINUED)
Title
Cancer Type
Treatment
Location
NCT Number
A Trial of Boost Vaccinations of Pancreatic Tumor Cell
Vaccine
Pancreatic Cancer
Biological: PANC 10.05 pcDNA-1/GM-Neo and
PANC 6.03 pcDNA-1 neo vaccine
MD
NCT01088789
Combination Chemotherapy With or Without Oregovomab
Followed By Stereotactic Body Radiation Therapy and
Nelfinavir Mesylate in Treating Patients With Locally
Advanced Pancreatic Cancer
Acinar Cell Adenocarcinoma of the
Pancreas, Duct Cell Adenocarcinoma
of the Pancreas, Recurrent Pancreatic
Cancer, Stage IA Pancreatic Cancer,
Stage IB Pancreatic Cancer, Stage IIA
Pancreatic Cancer, Stage IIB Pancreatic
Cancer, Stage III Pancreatic Cancer
Drug: gemcitabine hydrochloride;
Drug: leucovorin calcium; Biological:
oregovomab; Drug: nelfinavir mesylate;
Radiation: Stereotactic body radiation therapy;
Other: Laboratory biomarker analysis;
Drug: fluorouracil
NE
NCT01959672
Safety and Efficacy of Combination Listeria/GVAX Pancreas
Vaccine in the Pancreatic Cancer Setting
2nd-line, 3rd-line and Greater Metastatic
Pancreatic Cancer
Biological: GVAX Pancreas vaccine;
Biological: CRS-207; Drug: gemcitabine,
capecitabine, 5-FU, irinotecan or erlotinib;
AZ; CA; CO; FL;
IL; MD; MO; NC;
NY; OR; PA; TN;
VA; WA
NCT02004262
Title
Cancer Type
Treatment
Location
NCT Number
Penile Cancer
MD
NCT01585428
Title
Cancer Type
Treatment
Location
NCT Number
Radio Immunotherapy
Stomach Neoplasms
AL; CA
NCT01384253
MN; NY
NCT02042430
Title
Cancer Type
Treatment
Location
NCT Number
MD
NCT00034216
Phase II Study of Adenovirus/PSA Vaccine in Men With
Recurrent Prostate Cancer After Local Therapy APP21
Recurrent Prostate Cancer
Biological: Adenovirus/PSA vaccine
IA
NCT00583752
Adoptive Transfer of Autologous T Cells Targeted to Prostate
Specific Membrane Antigen (PSMA) for the Treatment of
Castrate Metastatic Prostate Cancer (CMPC)
Prostate Cancer
Biological: Engineered autologous T cells;
NY
NCT01140373
A Randomized, Double-blind, Phase III Efficacy Trial of
PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic
or Minimally Symptomatic Metastatic Castrate-Resistant
Prostate Cancer
Prostate Cancer Metastatic
Biological: PROSTVAC-V; Biological:
PROSTVAC-F; Drug: GM-CSF; Other: GM-CSF
Placebo; Biological: Placebo
AK; CA; CO; DC; FL; NCT01322490
IA; ID; IL; IN; LA;
MA; MD; MN; MO;
NC; ND; NE; NJ;
NV; NY; OH; OR; PA;
SC; TN; TX; UT; VA;
VT; WA; WI; WV
Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced
Prostate Cancer
Prostatic Neoplasms
Drug: CT-011 (Anti-PD1 Antibody); Other:
Sipuleucel-T (PROVENGE);
GA
NCT01420965
Phase III Study of ProstAtak Immunotherapy With Standard
Radiation Therapy for Localized Prostate Cancer
Prostate Cancer
Biological: ProstAtak(AdV-tk) + valacyclovir;
Biological: Placebo + valacyclovir
AZ; CO; MA; MD;
NM; NY; PA; TX
NCT01436968
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease
in Intermediate-to-high Risk Prostate Adenocarcinoma
Prostate Cancer,
Prostate Adenocarcinoma
Drug: C11-sodium acetate
AZ
NCT01530269
Ipilimumab and GM-CSF Immunotherapy for Prostate Cancer
Prostate Cancer
Drug: ipilimumab; Drug: GM-CSF
CA
NCT01530984
Combining Ipilimumab With Abiraterone Acetate Plus
Prednisone in Chemotherapy and Immunotherapy-naïve
Patients With Progressive Metastatic Castration-resistant
Prostate Cancer
Prostate Cancer
Drug: ipilimumab
IL; NY; OR
NCT01688492
A Neoadjuvant Study of Androgen Ablation Combined
With Cyclophosphamide and GVAX Vaccine for Localized
Prostate Cancer
Prostate Cancer Adenocarcinoma in Situ
Drug: degarelix acetate; Drug:
cyclophosphamide; Drug: GVAX
MD
NCT01696877
Monitoring Anti-Prostate Cancer Immunity Following
Stereotactic Body Radiotherapy (SBRT)
Oligometastatic Prostate Cancer
MN
NCT01777802
A Randomized Phase II Trial of Combining Sipuleucel-T With
Immediate vs. Delayed CTLA-4 Blockade for Prostate Cancer
Prostate Cancer
CA; TX
NCT01804465
PENILE
PERITONEAL
PROSTATE
Drug: sipuleucel-T treatment; Drug:
ipilimumab
29
9/17/2014 9:16:09 AM
CLINICAL TRIALS
PROSTATE - VAGINAL
PROSTATE (CONTINUED)
Title
Cancer Type
Treatment
Location
NCT Number
Sipuleucel-T With or Without Radiation Therapy in
Treating Patients With Hormone-Resistant Metastatic
Prostate Cancer
Adenocarcinoma of the Prostate,
Bone Metastases, Hormone-resistant
Prostate Cancer, Recurrent Prostate
Cancer, Soft Tissue Metastases,
Stage IV Prostate Cancer
Biological: sipuleucel-T; Radiation: External
beam radiation therapy; Other: Laboratory
biomarker analysis
CA; UT
NCT01807065
Sipuleucel-T and Stereotactic Ablative Body Radiation
(SABR) for Metastatic Castrate-resistant Prostate Cancer
(mCRPC)
Metastatic Castrate-resistant Prostate
Cancer, mCRPC
Drug: sipuleucel-T; Radiation: Stereotactic
ablative body radiation
TX
NCT01818986
Enzalutamide With or Without Vaccine Therapy for
Advanced Prostate Cancer
Prostate Cancer
Biological: PROSTVAC-F/TRICOM;
Biological: PROSTVAC-V/TRICOM;
Drug: enzalutamide (Xtandi)
MD
NCT01867333
Enzalutamide in Combination With PSA-TRICOM in Patients
With Non-Metastatic Castration Sensitive Prostate Cancer
Prostate Cancer
Biological: PROSTVAC-F/TRICOM;
Biological: PROSTVAC-V/TRICOM;
Drug: enzalutamide (Xtandi)
MD
NCT01875250
Biological Therapy With or Without Vaccine Therapy in
Treating Patients With Metastatic Hormone-Resistant
Prostate Cancer
Hormone-resistant Prostate Cancer,
Recurrent Prostate Cancer, Stage IV
Prostate Cancer
Biological: glycosylated recombinant
human interleukin-7; Other: laboratory
biomarker analysis
CA; GA; NH; NY;
WA
NCT01881867
Combining Ipilimumab, Degarelix, and Radical
Prostatectomy in Men With Newly Diagnosed Metastatic
Castration Sensitive Prostate Cancer or Ipilimumab and
Degarelix in Men With Biochemically Recurrent Castration
Sensitive Prostate Cancer After Radical Prostatectomy
Metastatic Castration Sensitive
Prostate Cancer
Drug: degarelix; Drug: ipilimumab;
Procedure: Radical prostatectomy
NY
NCT02020070
Dendreon Lymph Node Biopsy in Metastatic CastrateResistant Prostate Cancer
Prostate Cancer
Drug: sipuleucel-T;
Procedure: Lymph node biopsy
NC
NCT02036918
PET/MR Assessment of Sipuleucel-T Treatment for
Metastatic Castration Resistant Prostate Cancer
Prostate Cancer
Device: PET/CT; Device: PET/MRI
NY
NCT02042053
Lung Cancer, Breast Cancer,
Prostate Cancer, Tumors (Others)
MD
NCT02179515
Title
Cancer Type
Treatment
Location
NCT Number
Urothelial Cancer
Urethra Cancer, Ureter Cancer, Malignant
Tumor of Renal Pelvis
Biological: ALT-801
AZ; CA; FL; GA; IA;
IL; KS; LA; MI; MO;
NC; NY; OK; PA
NCT01326871
Title
Cancer Type
Treatment
Location
NCT Number
Bladder Cancer
MD
NCT00001823
Metronomic Oral Cyclophosphamide and Celecoxib
in Patients Undergoing Resection of Lung and
Esophageal Cancers, Thymic Neoplasms, and Malignant
Pleural Mesotheliomas
Biological: Allogeneic tumor cell vaccine
(K562); Drug: celecoxib;
MD
NCT01143545
After Tumor Removal
Drug: celecoxib
MD
NCT01341496
Autologous T Cells and Cyclophosphamide in Treating
Patients With Soft Tissue Sarcoma That is Metastatic or
Cannot Be Removed By Surgery
Adult Liposarcoma, Adult Synovial
Sarcoma, Recurrent Adult Soft Tissue
Sarcoma, Stage III Adult Soft Tissue
Sarcoma, Stage IV Adult Soft Tissue
Sarcoma
Drug: cyclophosphamide;
Biological: NY-ESO-1-specific T cells;
WA
NCT01477021
Breast Cancer
AZ; FL; MI; NY
NCT02015416
Biological: H1299 lysate vaccine;
Drug: cyclophosphamide; Drug: celecoxib
MD
NCT02054104
Phase II STIR Trial: Haploidentical Transplant and Donor
Natural Killer Cells for Solid Tumors
Ewing Sarcoma, Neuroblastoma,
Rhabdomyosarcoma
Procedure: Allogeneic HCT; Drug: Donor NK
cell infusion
WI
NCT02100891
RENAL PELVIS
SARCOMA
30
9/17/2014 9:16:09 AM
SARCOMA (CONTINUED)
Title
Cancer Type
Treatment
Location
NCT Number
A Phase I Trial of T Cells Expressing an Anti-GD2 Chimeric
Antigen Receptor in Children and Young Adults With Nonneuroblastoma, GD2+ Solid Tumors
Sarcoma, Osteosarcoma,
Rhabdomyosarcoma,
Ewing Sarcoma, Melanoma
Other: Anti-GD2.28.z.OX40.ICD9 (anti-GD2
CAR) retroviral transduced autologous
peripheral blood lymphocytes);
Drug: AP1903 dimerizing agent
MD
NCT02107963
Expressing NY-ESO-1
CT; MA; MN;
TX; WA
NCT02122861
Activated T Cells Armed With GD2 Bispecific
Antibody in Children and Young Adults With Neuroblastoma
and Osteosarcoma
Desmoplastic Small Round Cell
Tumor, Disseminated Neuroblastoma,
Metastatic Childhood Soft Tissue
Sarcoma, Metastatic Ewing Sarcoma/
PNET, Metastatic Osteosarcoma,
Recurrent Adult Soft Tissue Sarcoma,
Recurrent Childhood Soft Tissue
Sarcoma, Recurrent Ewing Sarcoma/
PNET, Recurrent Melanoma, Recurrent
Neuroblastoma, Recurrent Osteosarcoma
Biological: aldesleukin; Biological: OKT3/
humanized 3F8 bispecific antibody-activated T
lymphocytes; Biological: sargramostim;
MI; NY
NCT02173093
Adoptive Therapy Using Antigen-Specific CD4 T-Cells
Melanoma, Sarcoma
Drug: ipilimumab; Drug: cyclophosphamide;
Biological: CD4+ T cells
TX
NCT02210104
Title
Cancer Type
Treatment
Location
NCT Number
CNS Lymphoma
Brain and Central Nervous System
Tumors, Lymphoma, Lymphoproliferative
Disorder, Small Intestine Cancer
TX
NCT00621036
Tract Cancers
Hepatocellular Carcinoma,
Metastatic Cholangiocarcinoma
MD
NCT01174121
Title
Cancer Type
Treatment
Location
NCT Number
Tract Cancers
Hepatocellular Carcinoma,
Metastatic Cholangiocarcinoma
MD
NCT01174121
Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio
Immunotherapy
Stomach Neoplasms
AL; CA
NCT01384253
SMALL INTESTINE
STOMACH
URETER
Title
Cancer Type
Treatment
Location
NCT Number
Urothelial Cancer
Biological: ALT-801
AZ; CA; FL; GA; IA;
IL; KS; LA; MI; MO;
NC; NY; OK; PA
NCT01326871
Title
Cancer Type
Treatment
Location
NCT Number
Urothelial Cancer
Biological: ALT-801
AZ; CA; FL; GA; IA;
IL; KS; LA; MI; MO;
NC; NY; OK; PA
NCT01326871
Title
Cancer Type
Treatment
Location
NCT Number
Penile Cancer
MD
NCT01585428
URETHRA
VAGINAL
31
9/17/2014 9:16:09 AM
CLINICAL TRIALS
MISCELLANEOUS
MISCELLANEOUS
Title
Cancer Type
Treatment
Location
NCT Number
Immunotherapy of the Paraneoplastic Syndromes
Paraneoplastic Syndromes
Drug: tacrolimus (FK506)
NY
NCT00378326
Study of Cytokines in Children With
Opsoclonus-Myoclonus Syndrome
Opsoclonus-myoclonus Syndrome
IL
NCT00806182
Laboratory-Treated Autologous Lymphocytes,
Aldesleukin, and Sargramostim (GM-CSF) in Treating
Advanced Solid Tumors
Neoplasms, Tumors, Solid Tumors,
Metastatic Cancer
Biological: EGFRBi-armed autologous
activated T cells
RI
NCT01081808
Hybrid Immunotherapy for Hemophagocytic
LymphoHistiocytosis
Hemophagocytic Lymphohistiocytosis
Drug: ATG, rabbit; Drug: etoposide;
Drug: intrathecal methotrexate;
Drug: hydrocortisone
AZ; CA; FL; LA;
MA; OH; PA; TX
NCT01104025
Natural History Study of SCID Disorders
SCID, Leaky SCID, Omenn Syndrome,
Reticular Dysgenesis, ADA Deficiency,
XSCID
AL; CA; CO; DC;
FL; GA; IL; LA; MA;
MD; MI; MN; MO;
NC; NJ; NY; OH;
OR; PA; TX; UT;
WA; WI
NCT01186913
After Tumor Removal
MD
NCT01341496
Patients Treated for SCID (1968-2010)
SCID, ADA-SCID, XSCID, Leaky SCID,
Omenn Syndrome, Reticular Dysgenesis
AL; CA; CO; DC;
FL; GA; IL; LA; MA;
MD; MI; MN; MO;
NC; NJ; NY; OH;
OR; PA; TX; UT;
WA; WI
NCT01346150
Human Placental-Derived Stem Cell Transplantation
Mucopolysaccharidosis I,
Mucopolysaccharidosis VI,
Adrenoleukodystrophy, Niemann-Pick
Disease, Metachromatic Leukodystrophy,
Wolman Disease, Krabbe’s Disease,
Gaucher’s Disease, Fucosidosis,
Batten Disease, Severe Aplastic
Anemia, Diamond-Blackfan Anemia,
Amegakaryocytic Thrombocytopenia,
Myelodysplastic Syndrome, Acute
Myelogenous Leukemia, Acute
Lymphocytic Leukemia
Drug: Human placental derived stem cell
NY; UT
NCT01586455
Efficacy and Safety Study of Abatacept to Treat
Lupus Nephritis
Lupus Nephritis
Biological: BMS-188667; Drug: mycophenolate
mofetil; Drug: prednisone; Biological: Placebo
matching with BMS-188667
AL; CA; FL; GA;
LA; MA; NC; NJ;
NY; OH; TN; TX;
UT; VA
NCT01714817
Ipilimumab and Imatinib Mesylate in Advanced Cancer
Advanced Cancers
Drug: ipilimumab; Drug: imatinib mesylate
TX
NCT01738139
Immunotherapy for Recurrent Ependymomas in
Children Treatment for Recurrent Ependymomas Using
HLA-A2 Restricted Tumor Antigen Peptides in Combination
With Imiquimod
Recurrent Ependymoma
Biological: HLA-A2 restricted synthetic tumor
antigen; Drug: imiquimod; Genetic: Reverse
transcriptase-polymerase chain reaction;
Other: Enzyme-linked immunosorbent
assay; Other: Flow cytometry; Other:
Immunohistochemistry staining method;
PA
NCT01795313
Safety Study of Intratumoral Injection of Clostridium
Novyi-NT Spores to Treat Patients With Solid Tumors
That Have Not Responded to Standard Therapies
Solid Tumor Malignancies
Biological: Clostridium novyi-NT spores
IL; MD; MI; MO;
NY; OH; TX
NCT01924689
Phase II Study of Metastatic Cancer That Expresses
NY-ESO-1 Using Lymphodepleting Conditioning
Followed by Infusion of Anti-NYESO-1 Murine TCR-Gene
Engineered Lymphocytes
Metastatic Cancers Other Than
Melanoma That Express ESO Antigen
Biological: Anti-NY-ESO-1 mTCR PBL;
Biological: aldesleukin
MD
NCT01967823
Patients Treated for Chronic Granulomatous Disease (CGD)
Since 1995
Granulomatous Disease, Chronic
CA; DC; FL; GA;
LA; MA; MD; MI;
MO; NC; NJ; NY;
OH; OR; PA; TX;
UT; WA; WI
NCT02082353
Phase I/II Study of the Treatment of Metastatic Cancer
That Expresses MAGE-A3 Using Lymphodepleting
Conditioning Followed by Infusion of HLA-DP0401/0402
Restricted Anti-MAGE-A3 TCR-Gene Engineered
Lymphocytes and Aldesleukin
Metastatic Cancer That Express the
MAGE-A3-DP4 Antigen
MD
NCT02111850
32
Drug: celecoxib
Biological: Anti-MAGE-A3-DP4 TCR;
Drug: aldesleukin
9/17/2014 9:16:09 AM
GLOSSARY OF TERMS The immune system and immunotherapy
Adaptive immunity – A subsystem of the overall immune
system composed of specialized cells that eliminate infection and disease. This is the part of the immune system
that creates a battle plan and launches a specific attack
against every threat. This system is also characterized by a
“memory” response that allows the immune system to work
for prolonged periods of time.
Antibody – A protein created by B cells in direct response
to specific antigens. An antibody attaches itself to its respective antigen, marking it for other immune cells to “see”
and destroy.
Antigen – A protein on the surface of every cell or substance that alerts the immune system and causes the production of antibodies.
Antigen-presenting cells (APCs) – Special cells that digest harmful materials in the body to “show” to the T cells
so they recognize what to attack.
Apoptosis – A process in which cells self-destruct, which
helps regulate and limit the lifespan of cells. This process
often does not work in cancer cells.
B cells – Immune cells responsible for producing antibodies for specific antigens that will bind to the antigens and
mark them for destruction by other immune cells.
Cancer cells – Cells with damaged DNA that results in
changes in normal cell growth and division. New cancer
cells grow uncontrollably and old cancer cells don’t die
when they should, resulting in a malignant tumor. Cancer
cells can also spread to other parts of the body and grow.
Co-stimulatory signal – The second stimulation required
for T cells to become fully activated (Signal 2).
CTLA4 (cytotoxic T lymphocyte associated antigen 4) –
A protein receptor found on the surface of T cells. This protein is part of the CTLA4 checkpoint pathway, which can shut
down the immune system response in its early stages by
either preventing the positive signal necessary for activation
or sending negative signals to inactivate the T cell. Certain
cancer cells have the ability to engage this checkpoint,
which puts the brakes on the immune response.
Cytokines – Proteins released by immune cells to communicate with other immune cells; certain cytokines, such
as interferon and interleukin, help regulate specific immune
system functions.
Cytotoxic T cell – A type of T cell that destroys virally
infected cells and cancer cells through direct contact or via
a chemical signal. To keep cytotoxic T cells in check, their
activity is reduced by regulatory T cells when they are no
longer necessary; this helps prevent damage to healthy tissue (autoimmune disease).
Dendritic cell (DC) – A type of antigen-presenting cell
responsible for processing antigen material and presenting
it to the T cells for activation. DCs are also able to help
regulate other immune cells.
Downregulation – Reducing either the overall immune
system response or the specific responses of certain immune cells.
GM-CSF (Granulocyte-macrophage colony stimulating factor) – A cytokine protein responsible for stimulating bone marrow and promoting the growth of immune
cells, especially dendritic cells. GM-CSF is currently used
to restore white blood cells that have been depleted in
chemotherapy patients, and is being studied as a possible
immunotherapy treatment.
Immune cells – The cells of the immune system that are
involved in defending the body against infectious disease
and foreign invaders.
may include certain proteins or molecules on the surface
of the cancer cells; they are meant to stimulate an immune
response just as naturally produced antibodies do.
Immune checkpoint inhibitors – Drugs that block the
activation of specific immune checkpoint pathways.
Natural killer cells – White blood cells that contain enzymes that kill virally infected cells and tumor cells. They
also communicate with T cells to help regulate their development and response. These cells are part of the innate
immune response.
Immune checkpoint pathways – The system of checks
and balances in place to prevent over-activation of the
immune system. Different pathways function at different
stages of the immune system response to help regulate
the length and intensity of the T cell activity; engaging an
immune checkpoint typically results in shutting down the
immune system response.
Immunosuppression – Preventing the immune system
from launching a successful attack to protect the body
against infection and disease.
Immunotherapy – An innovative type of cancer treatment
that focuses on using the body’s own immune system to
fight cancer.
Immune-related adverse events (IRAEs) – Autoimmune
reactions that occur as a result of boosting the immune system. Severe reactions may include colitis, dermatitis and
hepatitis.
Innate immunity – A subsystem of the overall immune
system that detects and eliminates infection and disease
and activates adaptive immunity. This is the part of the immune system that finds the threat and sounds the alarm.
Interferon – A protein released by immune cells that helps
regulate different immune cell activity; types of interferon
include alfa, beta and gamma. Different types help regulate
different functions, including prompting increased T cell
activity, stimulating natural killer cells or affecting certain
cell functions that influence tumor cell growth. Man-made
versions of the IFN-alfa protein are currently FDA-approved
to treat certain types of cancer.
Interleukins – A set of proteins produced by T cells that
helps regulate the production of certain immune cells, how
they function during an immune response, and their production of cytokines. The man-made version of interleukin-2
(IL-2 or aldesleukin [Proleukin]), is currently FDA-approved
to treat metastatic melanoma and metastatic renal cell
carcinoma. Other interleukins are under study for possible
cancer-fighting ability.
Ligands – Protein molecules on the surface of a cell that bind
to the receptor on the surface of another cell. Most ligands are
signal-triggering molecules, which means they send out immune cell signals when engaged by a receptor. These signals
help to regulate specific immune system functions.
Major Histocompatibility Complex (MHC) – A set of
molecules on the surface of certain immune cells that influences the interaction with other immune cells by displaying the cells’ antigens. Antigen-presenting cells present
digested antigens to T cells through the MHC molecules on
their surface; this allows the T cell to “see” the antigen
and recognize it as foreign. The MHC–T cell receptor (TCR)
connection is the first signal necessary to activate the T cell
to respond to a tumor.
Memory cells – T cells and B cells from a specific immune
reaction that continue to circulate through the body even after the infection is resolved. They “remember” specific antigens and can multiply rapidly upon subsequent exposure,
creating an immediate immune response already trained to
eliminate the threat.
Neutrophil – A type of white blood cell responsible for
responding quickly to the site of injury or infection. Neutrophils contribute to acute inflammation and are the primary
component of pus.
Oncolytic virus – Viruses that have the ability to infect
and multiply within cancer cells, leading to cell death.
These viruses are tumor-selective, may be engineered
or naturally occurring, and can be used to target and destroy specific tumor cells and initiate an immune response
against the infected cancer cells.
PD-1 (programmed cell death-1) – The receptor in the
PD-1 checkpoint pathway that sends negative signals to the
T cell when it connects to a PD-L1 or PD-L2 ligand. These
negative signals normally slow down or stop the immune
response when it’s no longer necessary. Certain cancer cells
have the ability to influence the engagement of this checkpoint, which puts the brakes on the immune response.
Proliferation – Cell division and development (growth).
Receptors (immune receptors) – Proteins on the surface
of immune cells that bind to ligands on the surface of other
immune cells; this connection typically results in immune
cell signaling that regulates specific immune system functions.
Regulatory T cells – T cells that help maintain the necessity, strength and duration of an immune response by
regulating T cell activity. They shut down the other T cells
at the end of an immune reaction. Certain tumor cells have
the ability to increase regulatory T cell activity, which decreases the overall immune response.
Signal 1, Signal 2 – The primary and secondary cell signals necessary for the immune system to activate. Signal 1
is the Major Histocompatibility Complex (MHC) / Antigen-T
cell receptor (TCR) interaction between the antigen-presenting cell and the T cell; Signal 2 can be any number of
connections formed by the molecules and receptors on the
surfaces of both the APC and the T cell.
T cells – Adaptive immune cells responsible for recognizing specific antigens during antigen presentation; T cells
are the major players in the immune system’s fight against
cancer. Their activation and activity are two of the main focuses in immunotherapy research.
T cell receptors (TCRs) – Molecules found only on the
surface of T cells. TCRs must bind to special molecules on the
surface of antigen-presenting cells before they can receive
information about the threat. This connection is the first signal necessary to activate the T cell to respond to the tumor.
Tumor microenvironment – The area surrounding a tumor
inside which normal cells, molecules and blood vessels help
sustain the tumor. The microenvironment contributes to the
behavior, proliferation and spread of the tumor; the tumor
itself is capable of affecting its own microenvironment.
Upregulate – Increasing either the overall immune system
response or the specific responses of certain immune cells.
Monoclonal antibodies (mAbs) – Man-made antibodies
engineered to target specific parts of cancer cells, which
33
9/17/2014 9:28:06 AM
This patient education guide was produced with support from:
9/17/2014 9:28:07 AM

Cancer Immunotherapy - Society for Immunotherapy of Cancer

Transcription

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