Clinical trial: NCT02785952
Section: Alternatives
Subsections: |Who can answer my questions about this study?

Official Study Title for Internet Search on
http://www.ClinicalTrials.gov:  
S1400, "A Biomarker-Driven Master Protocol for Previously
Treated Squamous Cell Lung Cancer"  
S1400I, "A Phase III Randomized Study of Nivolumab Plus Ipilimumab
Versus Nivolumab for Previously Treated Patients with Stage IV
Squamous Cell Lung Cancer and No Matching Biomarker (Lung-MAP
Sub-Study)"  
What is the usual approach to my lung cancer?  
Squamous cell lung cancers make up about one-fourth of non-small cell lung cancer. Various
chemotherapy drugs have been shown to improve survival for patients with advanced squamous
cell lung cancer. Most patients, for example, will be treated at first with cisplatin or
carboplatin in combination with a second chemotherapy drug such as gemcitabine, paclitaxel,
docetaxel, or vinorelbine. In addition, immunotherapy has been recently FDA approved for
patients with previously untreated squamous cell lung cancer whose tumors have high expression
of a marker called PD-L1, as well as for patients who previously received chemotherapy and
then had progression of their cancer.  
What are my other choices if I do not take part in this study?  
Your other choices may include:  
You may choose to have the usual approach described above.
You may choose to take part in a different study, if one is available.
You may choose to get comfort care, also called palliative care. This type of care helps
reduce pain, tiredness, appetite problems and other problems caused by the cancer. It
does not treat the cancer directly, but instead tries to improve how you feel. Comfort care
tries to keep you as active and comfortable as possible.  
You may choose to have the usual approach described above.  
You may choose to take part in a different study, if one is available.  
You may choose to get comfort care, also called palliative care. This type of care helps
reduce pain, tiredness, appetite problems and other problems caused by the cancer. It
does not treat the cancer directly, but instead tries to improve how you feel. Comfort care
tries to keep you as active and comfortable as possible.  
Why is this study being done?  
There are several investigational treatments that are being tested in various sub-studies as
part of this study. You will have already received the information on your biomarker
testing. You have been assigned to this treatment study because your tumor sample did not
have a biomarker that matches one of the treatment studies or because you were not a

This part of the consent form is about optional studies that you can choose to take part in. You
will not get health benefits from any of these studies. The researchers leading this optional study
hope the results will help other people with cancer in the future.  
The results will not be added to your medical records, nor will you or your study doctor know
the results.  
You will not be billed for these optional studies. You can still take part in the main study even if
you say 'no' to any or all of these studies. If you sign up for but cannot complete any of the
studies for any reason, you can still take part in the main study.  
Circle your choice of "yes" or "no" for each of the following studies.
Clinical trial: NCT02785952
Section: Confidentiality
Subsections: |Who will see my medical information?|Where can I get more information?|HOW WILL INFORMATION ABOUT ME BE KEPT PRIVATE?|

*NOTES FOR LOCAL INSTITUTION INFORMED CONSENT AUTHORS:  
This model informed consent form has been reviewed by the DCTD/NCI and is the official
consent document for this study. Local IRB changes to this document are allowed. (Institutions
should attempt to use sections of this document that are in bold type in their entirety.) Editorial
changes to these sections may be made as long as they do not change information or intent. If
the institutional IRB insists on making additions, deletions, or more substantive modifications to
the risks or alternatives sections, they may be justified in writing by the investigator and
approved by the IRB. Under these circumstances, the revised language, justification and a copy
of the IRB minutes must be forwarded to the SWOG Operations Office for approval before a
patient may be registered to this study.  
Please particularly note that the questions related to banking of specimens for future study
are in bolded type and may not be changed in any way without prior approval from the
SWOG Operations Office.  
Readability Statistics:
Flesch Reading Ease
59.1
(targeted above 55)
Flesch-Kincaid Grade Level
9.2
(targeted below 8.5)  
Instructions and examples for informed consent authors are in [italics].
A blank line,
, indicates that the local investigator should provide the
appropriate information before the document is reviewed with the prospective research
participant.
The term "study doctor" has been used throughout the model because the local
investigator for a cancer treatment trial is a physician. If this model is used for a trial in
which the local investigator is not a physician, another appropriate term should be used
instead of "study doctor"
The dates of protocol updates in the header and in the text of the consent is for reference
to this model only and should not be included in the informed consent form given to the
prospective research participant.
The local informed consent must state which parties may inspect the research records.
This includes the NCI, the drug manufacturer for investigational studies, any companies
or grantors that are providing study support (these will be listed in the protocol's model
informed consent form) and SWOG.  
Instructions and examples for informed consent authors are in [italics].  
A blank line,
, indicates that the local investigator should provide the
appropriate information before the document is reviewed with the prospective research
participant.  
The term "study doctor" has been used throughout the model because the local
investigator for a cancer treatment trial is a physician. If this model is used for a trial in
which the local investigator is not a physician, another appropriate term should be used
instead of "study doctor"  
The dates of protocol updates in the header and in the text of the consent is for reference
to this model only and should not be included in the informed consent form given to the
prospective research participant.  
The local informed consent must state which parties may inspect the research records.
This includes the NCI, the drug manufacturer for investigational studies, any companies
or grantors that are providing study support (these will be listed in the protocol's model
informed consent form) and SWOG.  
"SWOG" must be listed as one of the parties that may inspect the research records in all
protocol consent forms for which patient registration is being credited to SWOG. This
includes consent forms for studies where all patients are registered directly through the
SWOG Data Operations Office, all intergroup studies for which the registration is being
credited to SWOG (whether the registration is through the SWOG Data Operations

Your privacy is very important to us and the researchers will make every effort to protect it.
Your information may be given out if required by law. For example, certain states require
doctors to report to health boards if they find a disease like tuberculosis. However, the
researchers will do their best to make sure that any information that is released will not identify
you. Some of your health information, and/or information about your specimen, from this study
will be kept in a central database for research. Your name or contact information will not be put
in the database.  
There are organizations that may inspect your records. These organizations are required to make
sure your information is kept private, unless required by law to provide information. Some of
these organizations are:  
The study sponsor, SWOG, and the drug company supporting the treatment sub-study
you are on.
The Institutional Review Board, IRB, is a group of people who review the research with
the goal of protecting the people who take part in the study.
The Food and Drug Administration (FDA) and the National Cancer Institute (NCI) in the
U.S., and similar ones if other countries are involved in the study.
Transmission of Imaging and Data (TRIAD) and Imaging and Radiation Oncology Core
(IROC)-Your medical images with clinical study data (e.g., the treatment Group you are
assigned to, etc.) will be transferred via TRIAD to IROC at Ohio State University in
Columbus, Ohio. Your medical images will be reviewed by physicians at this
organization as part of the study analysis for this trial. In addition, information gained
from this study may be used in the future for additional research and only that data would
be provided to other scientist for future research. Your name, and any other information
that could be used to identify you personally, will not be included.  
The study sponsor, SWOG, and the drug company supporting the treatment sub-study
you are on.  
The Institutional Review Board, IRB, is a group of people who review the research with
the goal of protecting the people who take part in the study.  
The Food and Drug Administration (FDA) and the National Cancer Institute (NCI) in the
U.S., and similar ones if other countries are involved in the study.  
Transmission of Imaging and Data (TRIAD) and Imaging and Radiation Oncology Core
(IROC)-Your medical images with clinical study data (e.g., the treatment Group you are
assigned to, etc.) will be transferred via TRIAD to IROC at Ohio State University in
Columbus, Ohio. Your medical images will be reviewed by physicians at this
organization as part of the study analysis for this trial. In addition, information gained
from this study may be used in the future for additional research and only that data would
be provided to other scientist for future research. Your name, and any other information
that could be used to identify you personally, will not be included.

You may visit the NCI Web site at http://cancer.gov/ for more information about studies or
general information about cancer. You may also call the NCI Cancer Information Service to get
the same information at: 1-800-4-CANCER (1-800-422-6237).  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required
by U.S. Law. This Web site will not include information that can identify you. At most, the Web
site will include a summary of the results. You can search this Web site at any time.  
[Note to Informed Consent Authors: The above paragraph complies with the new FDA
regulation found at 21CFR50.25 (c) and must be included verbatim in all informed consent
documents. The text in this paragraph cannot be revised.]

Your privacy is very important to the researchers and they will make every effort to protect it.
Here are just a few of the steps they will take:  
1) When your samples are sent to the researchers, no information identifying you (such
as your name) will be sent. Samples will be identified by a unique code only.
2) The list that links the unique code to your name will be kept separate from your
sample and health information. Any Biobank and SWOG staff with access to the list
must sign an agreement to keep your identity confidential.
3) Researchers to whom SWOG sends your sample and information will not know who
you are. They must also sign an agreement that they will not try to find out who you
are.
4) Information that identifies you will not be given to anyone, unless required by law.
5) If research results are published, your name and other personal information will not
be used.  
1) When your samples are sent to the researchers, no information identifying you (such
as your name) will be sent. Samples will be identified by a unique code only.  
2) The list that links the unique code to your name will be kept separate from your
sample and health information. Any Biobank and SWOG staff with access to the list
must sign an agreement to keep your identity confidential.  
3) Researchers to whom SWOG sends your sample and information will not know who
you are. They must also sign an agreement that they will not try to find out who you
are.  
4) Information that identifies you will not be given to anyone, unless required by law.  
5) If research results are published, your name and other personal information will not
be used.

|    |                                                                                                                                                                                                                               |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) | When your samples are sent to the researchers, no information identifying you (such as your name) will be sent. Samples will be identified by a unique code only.                                                             |
| 2) | The list that links the unique code to your name will be kept separate from your sample and health information. Any Biobank and SWOG staff with access to the list must sign an agreement to keep your identity confidential. |
| 3) | Researchers to whom SWOG sends your sample and information will not know who you are. They must also sign an agreement that they will not try to find out who you are.                                                        |
| 4) | Information that identifies you will not be given to anyone, unless required by law. If research results are published, your name and other personal information will not be used.                                            |
| 5) |                                                                                                                                                                                                                               |
Clinical trial: NCT02785952
Section: Duration of Study Involvement
Subsections: What are the study groups?

Another way to find out what may happen to you during the study is to read the chart below.
Start reading at the top of the chart and read down, following the arrows.  
Screening/Pre-Screening Registration  
How long will I be in this study?  
You will receive treatment until your disease worsens. After you are finished taking study
treatment, the study doctor will continue to watch you for side effects and follow your condition
for 3 years from the time you started treatment. At the follow up visits you will have a physical
exam, blood tests, and scans. Your doctor may give you other tests or procedures if they think
they are needed.  
What extra tests and procedures will I have if I take part in this study?  
Most of the exams, tests, and procedures you will have are part of the usual approach for your
cancer. However, there are some extra exams, tests, and/or procedures that you will need to have
if you take part in this study.  
The leftover tumor sample from the screening biomarker testing will undergo an additional lab
test. The test is being performed to see if you have a biomarker called PD-L1. PD-L1 is a
genetic feature or specific protein found in the tumor sample. You will not have another
surgery. The samples will be kept until there are no additional sub-studies for you to enroll in or
they are used up, whichever happens first. If any tumor is left over after the laboratory studies
and there are no additional sub-studies for you to enroll in, and if you agreed, it will be stored for
biobanking. This was discussed in the screening consent section on optional studies.
Clinical trial: NCT02785952
Section: Participant Responsibilities

|    |                                                                                                                                                 |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------|
|  1 | If my cancer responds to study treatment, I agree to have another biopsy after completing study treatment to collect a sample of tissue. YES NO |
|  2 | My tumor tissue and related information may be kept in a Biobank for use in future health research. YES NO                                      |
|  3 | My blood samples and related information may be kept in a Biobank for use in future health research. YES NO                                     |
Clinical trial: NCT02785952
Section: Participant's Rights
Subsections: |WHAT IF I HAVE MORE QUESTIONS?

Page 2  
Office or directly through the other group), as well as consent forms for studies where
patients are registered via CTSU and the registration is credited to SWOG.  
When changes to the protocol require revision of the informed consent document, the
IRB should have a system that identifies the revised consent document, in order to
preclude continued use of the older version and to identify file copies. An appropriate
method to identify the current version of the consent is for the IRB to stamp the final
copy of the consent document with the approval date. The stamped consent document is
then photocopied for use. Other systems of identifying the current version of the consent
such as adding a version or approval date are allowed as long as it is possible to
determine during an audit that the patient signed the most current version of the consent
form.  
*NOTES FOR LOCAL INVESTIGATORS:  
The goal of the informed consent process is to provide people with sufficient information
for making informed choices. The informed consent form provides a summary of the
clinical study and the individual's rights as a research participant. It serves as a starting
point for the necessary exchange of information between the investigator and potential
research participant. This model for the informed consent form is only one part of the
larger process of informed consent. For more information about informed consent, review
the "Recommendations for the Development of Informed Consent Documents for Cancer
Clinical Trials" prepared by the Comprehensive Working Group on Informed Consent in
Cancer Clinical Trials for the National Cancer Institute. The Web site address for this
document is http://cancer.gov/clinicaltrials/understanding/simplification-of-informed-
consent-docs/
A blank line,
, indicates that the local investigator should provide the
appropriate information before the document is reviewed with the prospective research
participant.
Suggestion for Local Investigators: An NCI pamphlet explaining clinical trials is
available for your patients. The pamphlet is titled: "Taking Part in Cancer Treatment
Research Studies". This pamphlet may be ordered on the NCI Web site at
https://cissecure.nci.nih.gov/ncipubs or call 1-800-4- CANCER (1-800-422-6237) to
request a free copy.
Optional feature for Local Investigators: Reference and attach drug sheets,
pharmaceutical information for the public, or other material on risks. Check with your
local IRB regarding review of additional materials.  
The goal of the informed consent process is to provide people with sufficient information
for making informed choices. The informed consent form provides a summary of the
clinical study and the individual's rights as a research participant. It serves as a starting
point for the necessary exchange of information between the investigator and potential
research participant. This model for the informed consent form is only one part of the
larger process of informed consent. For more information about informed consent, review
the "Recommendations for the Development of Informed Consent Documents for Cancer
Clinical Trials" prepared by the Comprehensive Working Group on Informed Consent in
Cancer Clinical Trials for the National Cancer Institute. The Web site address for this
document is http://cancer.gov/clinicaltrials/understanding/simplification-of-informed-
consent-docs/  
A blank line,
, indicates that the local investigator should provide the
appropriate information before the document is reviewed with the prospective research
participant.  
Suggestion for Local Investigators: An NCI pamphlet explaining clinical trials is
available for your patients. The pamphlet is titled: "Taking Part in Cancer Treatment
Research Studies". This pamphlet may be ordered on the NCI Web site at
https://cissecure.nci.nih.gov/ncipubs or call 1-800-4- CANCER (1-800-422-6237) to
request a free copy.  
Optional feature for Local Investigators: Reference and attach drug sheets,
pharmaceutical information for the public, or other material on risks. Check with your
local IRB regarding review of additional materials.  
*These notes for authors and investigators are instructional and should not be included in the
informed consent form given to the prospective research participant.

If you have questions about the use of your samples for research, contact the study doctor,
, (insert name of study doctor for main trial), at
(insert telephone number of study doctor for main trial).  
Please circle your answer to show whether or not you would like to take part in each option:
Clinical trial: NCT02785952
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What possible risks can I expect from taking part in this study?|What possible risks can I expect from taking part in this study?|COMMON, SOME MAY BE SERIOUS|OCCASIONAL, SOME MAY BE SERIOUS|OCCASIONAL, SOME MAY BE SERIOUS|OCCASIONAL, SOME MAY BE SERIOUS|COMMON, SOME MAY BE SERIOUS|COMMON, SOME MAY BE SERIOUS|COMMON, SOME MAY BE SERIOUS|What are the costs of taking part in this study?|What happens if I am injured or hurt because I took part in this study?|WHAT ARE THE POSSIBLE RISKS?|WHAT ARE THE POSSIBLE RISKS?|WHAT ARE THE POSSIBLE BENEFITS?

If you choose to take part in this study, there is a risk that the treatment may not be as good as
the usual approach for your cancer or condition at shrinking or stabilizing your cancer.  
You also may have the following discomforts:  
Spend more time in the hospital or doctor's office.
Be asked sensitive or private questions about things you normally do not discuss.
May not be able to take part in future studies.  
Spend more time in the hospital or doctor's office.  
Be asked sensitive or private questions about things you normally do not discuss.  
May not be able to take part in future studies.  
The treatment used in this study may affect how different parts of your body work such as your
liver, kidneys, heart, and blood. The study doctor will test your blood and will let you know if
changes occur that may affect your health.  
There is also a risk that you could have side effects from the study drug(s)/study approach.  
Here are important things to know about side effects:  
The study doctors do not know who will or will not have side effects.
Some side effects may go away soon, some may last a long time, and some may never go
away.
Some side effects may make it hard for you to have children.
Some side effects may be mild. Other side effects may be very serious and even result in
death.  
The study doctors do not know who will or will not have side effects.  
Some side effects may go away soon, some may last a long time, and some may never go
away.  
Some side effects may make it hard for you to have children.  
Some side effects may be mild. Other side effects may be very serious and even result in
death.  
You can ask your study doctor questions about side effects at any time. Here are important ways
to make side effects less of a problem:  
If you notice or feel anything different, tell your study doctor. He or she can check to see
if it is a side effect.
Your study doctor will work with you to treat your side effects.
Your study doctor may adjust the study drugs to try to reduce side effects.  
If you notice or feel anything different, tell your study doctor. He or she can check to see
if it is a side effect.  
Your study doctor will work with you to treat your side effects.  
Your study doctor may adjust the study drugs to try to reduce side effects.  
The tables below show the most common and the most serious side effects doctors know about.
Keep in mind that there might be other side effects doctors do not yet know about. If important
new side effects are found, the study doctor will discuss these with you.

Special precautions:  
Side effects of nivolumab may happen anytime during treatment or even after your
treatment has ended. Some of these problems may happen more often when nivolumab is
used in combination with ipilimumab. Call or see your healthcare provider right away
if you develop any problems listed below or the symptoms get worse.

In 100 people receiving nivolumab, more than 20 and up to 100 may have:  
Tiredness

In 100 people receiving nivolumab, from 4 to 20 may have:  
Anemia which may require blood transfusion
Swelling and redness of the eye
Pain
Diarrhea, nausea
Dry mouth
Fever
Swelling and redness at the site of the medication injection
Bruising, bleeding
Pain or swelling of the joints
Loss of appetite
Reaction during or following a drug infusion which may cause fever, chills, rash  
Anemia which may require blood transfusion  
Swelling and redness of the eye  
Pain  
Diarrhea, nausea  
Dry mouth  
Fever  
Swelling and redness at the site of the medication injection  
Bruising, bleeding  
Pain or swelling of the joints  
Loss of appetite  
Reaction during or following a drug infusion which may cause fever, chills, rash  
Nivolumab may cause your immune system to attack normal organs and cause side effects
in many parts of the body. These problems may include but are not limited to:  
Lung problems (pneumonitis and pleural effusion). Symptoms may include: new or
worsening cough, chest pain, shortness of breath.
Intestinal problems (colitis) that can rarely lead to tears or holes in your intestine.
Signs and symptoms of colitis may include: diarrhea or increase in bowel
movements, blood in your stools or dark, tarry, sticky stools, severe belly pain or
tenderness.
Skin: itching; rash, blisters including inside the mouth; loss of skin pigment
Liver problems (hepatitis) which can cause liver failure. Signs and symptoms of
hepatitis may include: yellowing of your skin or the whites of your eyes, severe
nausea or vomiting; drowsiness; pain in the right upper belly
Hormone gland problems (especially the thyroid, pituitary and adrenal glands, and
pancreas). Signs and symptoms may include: headaches that will not go away or
unusual headaches, extreme tiredness or changes in mood or behavior; decreased
sex drive; weight loss or weight gain; excessive thirst or urination; dizziness or
fainting.  
Lung problems (pneumonitis and pleural effusion). Symptoms may include: new or
worsening cough, chest pain, shortness of breath.  
Intestinal problems (colitis) that can rarely lead to tears or holes in your intestine.
Signs and symptoms of colitis may include: diarrhea or increase in bowel
movements, blood in your stools or dark, tarry, sticky stools, severe belly pain or
tenderness.  
Skin: itching; rash, blisters including inside the mouth; loss of skin pigment  
Liver problems (hepatitis) which can cause liver failure. Signs and symptoms of
hepatitis may include: yellowing of your skin or the whites of your eyes, severe
nausea or vomiting; drowsiness; pain in the right upper belly  
Hormone gland problems (especially the thyroid, pituitary and adrenal glands, and
pancreas). Signs and symptoms may include: headaches that will not go away or
unusual headaches, extreme tiredness or changes in mood or behavior; decreased
sex drive; weight loss or weight gain; excessive thirst or urination; dizziness or
fainting.

In 100 people receiving nivolumab, 3 or fewer may have:  
Dry eyes
Sores in the mouth which may cause difficulty swallowing
A syndrome starting with flu-like symptoms and followed by swelling, tenderness
which may cause blurred vision, ringing in the ears, changes in hair or hair loss.
Swelling of the bowels  
Dry eyes  
Sores in the mouth which may cause difficulty swallowing  
A syndrome starting with flu-like symptoms and followed by swelling, tenderness
which may cause blurred vision, ringing in the ears, changes in hair or hair loss.  
Swelling of the bowels  
Nivolumab may cause your immune system to attack normal organs and cause side effects
in many parts of the body. These problems may include but are not limited to:  
Visual disturbances which may cause double vision, blurred vision, or loss of
vision with a chance of blindness
A condition with high blood sugar which leads to tiredness, frequent urination,
excessive thirst, headache, nausea and vomiting, and can result in coma
Kidney problems, including nephritis and kidney failure requiring dialysis. Signs
of kidney problems may include: decrease in the amount of urine, blood in your
urine, ankle swelling.
Heart problems including swelling and heart failure. Symptoms and signs of heart
problem may include: Shortness of breath, swelling of the ankle and body.
Problem of the muscle, including swelling, which can cause muscle pain and severe
muscle weakness sometimes with dark urine
Swelling of the brain (meningitis/encephalitis) which may cause: headache, stiff
neck, confusion, sleepiness, seizures or injury to the brain which may cause
headache, blindness (also known as Reversible Posterior Leukoencephalopathy
Syndrome)
Problem of the nerves that can cause paralysis. Signs and symptoms may include:
numbness, tingling of hands and feet; weakness of the arms, legs and facial muscle
movement
Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of
breath, swelling of the face or throat
Complications associated with stem cell transplant using donor stem cells
(allogeneic stem cell transplant). These complications are caused by attack of
donor cells on the host organs (inducing liver, skin and gut damage), and can lead
to death. If you are considering an allogeneic stem transplant after participating in
this study, please tell your doctor that you have received nivolumab therapy, since
the risk and severity of transplant-associated complications may be increased.  
Visual disturbances which may cause double vision, blurred vision, or loss of
vision with a chance of blindness  
A condition with high blood sugar which leads to tiredness, frequent urination,
excessive thirst, headache, nausea and vomiting, and can result in coma  
Kidney problems, including nephritis and kidney failure requiring dialysis. Signs
of kidney problems may include: decrease in the amount of urine, blood in your
urine, ankle swelling.  
Heart problems including swelling and heart failure. Symptoms and signs of heart
problem may include: Shortness of breath, swelling of the ankle and body.  
Problem of the muscle, including swelling, which can cause muscle pain and severe
muscle weakness sometimes with dark urine  
Swelling of the brain (meningitis/encephalitis) which may cause: headache, stiff
neck, confusion, sleepiness, seizures or injury to the brain which may cause
headache, blindness (also known as Reversible Posterior Leukoencephalopathy
Syndrome)  
Problem of the nerves that can cause paralysis. Signs and symptoms may include:
numbness, tingling of hands and feet; weakness of the arms, legs and facial muscle
movement  
Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of
breath, swelling of the face or throat  
Complications associated with stem cell transplant using donor stem cells
(allogeneic stem cell transplant). These complications are caused by attack of
donor cells on the host organs (inducing liver, skin and gut damage), and can lead
to death. If you are considering an allogeneic stem transplant after participating in
this study, please tell your doctor that you have received nivolumab therapy, since
the risk and severity of transplant-associated complications may be increased.

Special precautions  
after Side effects of ipilimumab (MDX-010) may happen anytime during treatment
ipilimumab your treatment has ended. Some of these problems may happen more often or even
the see your healthcare provider right away if you develop any problems listed below or or
(MDX-010) is used in combination with BMS-936558 (nivolumab). when Call
symptoms get worse.

In 100 people receiving ipilimumab (MDX-010), more than 20 and up to 100 may have:  
Diarrhea, nausea
Tiredness  
Diarrhea, nausea  
Tiredness  
cause Ipilimumab side (MDX-010) may cause your immune system to attack normal
limited to: effects in many parts of the body. These problems may include organs but are and not  
Skin: itching; rash, blisters including inside the mouth (can be severe); hives

In 100 people receiving ipilimumab (MDX-010), from 4 to 20 may have:  
Abnormal heartbeat
Hearing loss
Swelling and redness of the eye
Pain
Difficulty swallowing, eating
Constipation, vomiting
Weight loss, loss of appetite
Fever
Dehydration
Pain or swelling of the joints
Reaction during or following a drug infusion which may cause fever, chills, rash
Low blood pressure which may cause feeling faint  
Abnormal heartbeat  
Hearing loss  
Swelling and redness of the eye  
Pain  
Difficulty swallowing, eating  
Constipation, vomiting  
Weight loss, loss of appetite  
Fever  
Dehydration  
Pain or swelling of the joints  
Reaction during or following a drug infusion which may cause fever, chills, rash  
Low blood pressure which may cause feeling faint  
Ipilimumab (MDX-010) may cause your immune system to attack normal organs and
cause side effects in many parts of the body. These problems may include but are not
limited to:  
Lung problems (pneumonitis). Symptoms may include: new or worsening cough,
chest pain, shortness of breath.
Intestinal problems (colitis) that can rarely lead to tears or holes in your intestine.
Signs and symptoms of colitis may include: diarrhea or increase in bowel
movements, blood in your stools or dark, tarry, sticky stools, severe belly pain or
tenderness.
Kidney problems, including nephritis and kidney failure requiring dialysis. Signs
of kidney problems may include: decrease in the amount of urine, blood in your
urine, ankle swelling.
Problem of the muscle, including swelling, which can cause muscle pain and
severe muscle weakness sometimes with dark urine.
Problem of the nerves that can cause paralysis. Signs and symptoms may include:
numbness, tingling of hands and feet; weakness of the arms, legs and facial
muscle movement.
Liver problems (hepatitis) which can cause liver failure. Signs and symptoms of
hepatitis may include: yellowing of your skin or the whites of your eyes, severe
nausea or vomiting; drowsiness; pain in the right upper belly.
Hormone gland problems (especially the thyroid, pituitary and adrenal glands, and
pancreas). Signs and symptoms may include: headaches that will not go away or
unusual headaches, extreme tiredness or changes in mood or behavior decreased
sex drive; weight loss or weight gain; excessive thirst or urine; dizziness or
fainting.  
Lung problems (pneumonitis). Symptoms may include: new or worsening cough,
chest pain, shortness of breath.  
Intestinal problems (colitis) that can rarely lead to tears or holes in your intestine.
Signs and symptoms of colitis may include: diarrhea or increase in bowel
movements, blood in your stools or dark, tarry, sticky stools, severe belly pain or
tenderness.  
Kidney problems, including nephritis and kidney failure requiring dialysis. Signs
of kidney problems may include: decrease in the amount of urine, blood in your
urine, ankle swelling.  
Problem of the muscle, including swelling, which can cause muscle pain and
severe muscle weakness sometimes with dark urine.  
Problem of the nerves that can cause paralysis. Signs and symptoms may include:
numbness, tingling of hands and feet; weakness of the arms, legs and facial
muscle movement.  
Liver problems (hepatitis) which can cause liver failure. Signs and symptoms of
hepatitis may include: yellowing of your skin or the whites of your eyes, severe
nausea or vomiting; drowsiness; pain in the right upper belly.  
Hormone gland problems (especially the thyroid, pituitary and adrenal glands, and
pancreas). Signs and symptoms may include: headaches that will not go away or
unusual headaches, extreme tiredness or changes in mood or behavior decreased
sex drive; weight loss or weight gain; excessive thirst or urine; dizziness or
fainting.

In 100 people receiving ipilimumab (MDX-010), 3 or fewer may have:  
Bleeding
Blockage of the bowels which may cause constipation
Fluid around heart
Severe illness with multiorgan failure
Confusion  
Bleeding  
Blockage of the bowels which may cause constipation  
Fluid around heart  
Severe illness with multiorgan failure  
Confusion  
Ipilimumab (MDX-010) may cause your immune system to attack normal organs and
cause side effects in many parts of the body. These problems may include but are not
limited to:  
A condition with high blood sugar which leads to tiredness, frequent urination,
excessive thirst, headache, nausea and vomiting, and can result in coma
Heart problems including swelling and heart failure. Symptoms and signs of
heart problem may include: Shortness of breath, swelling of the ankle and
body.
Complications associated with stem cell transplant using donor stem cells
(allogeneic stem cell transplant). These complications are caused by attack of
donor cells on the host organs (inducing liver, skin and gut), and can lead to
death. If you are considering an allogeneic stem transplant after participating
in this study, please tell your doctor that you have received ipilimumab
therapy, since the risk and severity of transplant-associated complications may
be increased.
Swelling of the brain (meningitis/encephalitis), which may cause: headache,
confusion, sleepiness, seizures, and stiff neck.  
A condition with high blood sugar which leads to tiredness, frequent urination,
excessive thirst, headache, nausea and vomiting, and can result in coma  
Heart problems including swelling and heart failure. Symptoms and signs of
heart problem may include: Shortness of breath, swelling of the ankle and
body.  
Complications associated with stem cell transplant using donor stem cells
(allogeneic stem cell transplant). These complications are caused by attack of
donor cells on the host organs (inducing liver, skin and gut), and can lead to
death. If you are considering an allogeneic stem transplant after participating
in this study, please tell your doctor that you have received ipilimumab
therapy, since the risk and severity of transplant-associated complications may
be increased.  
Swelling of the brain (meningitis/encephalitis), which may cause: headache,
confusion, sleepiness, seizures, and stiff neck.  
Let your study doctor know of any questions you have about possible side effects. You can ask
the study doctor questions about side effects at any time.  
Reproductive risks: You should not get pregnant, breastfeed, or father a baby while in this study
as the drugs used in this study could be very damaging to an unborn baby. Women who receive
these drugs should use effective contraception during the period of the trial and for at least 5
months after completion of treatment. Men who receive these drugs should use effective
contraception during the period of the trial and for at least 7 months after completion of
treatment. Check with the study doctor about what types of birth control, or pregnancy
prevention, to use while in this study.

The nivolumab and ipilimumab will be supplied at no charge while you take part in this study.
The cost of getting the nivolumab and ipilimumab ready and giving it to you is not paid by the
study sponsor SO you or your insurance company may have to pay for this. It is possible that the
nivolumab and ipilimumab may not continue to be supplied while you are on the study. Although
not likely, if this occurs, your study doctor will talk to you about your options.  
You and/or your health plan/insurance company will need to pay for all of the other costs of
treating your cancer while in this study, including the cost of tests, procedures, or medicines to
manage any side effects, unless you are told that certain tests are supplied at no charge. Before

If you are injured or hurt as a result of taking part in this study and need medical treatment,
please tell your study doctor. The study sponsors will not offer to pay for medical treatment for
injury. Your insurance company may not be willing to pay for study-related injury. If you have
no insurance, you would be responsible for any costs.  
If you feel this injury was a result of medical error, you keep all your legal rights to receive
payment for this even though you are in a study.

1) There is a risk that someone could get access to the personal information in your
medical records or other information researchers have stored about you.
2) There is a risk that someone could trace the information in a central database back to
you. Even without your name or other identifiers, your genetic information is unique  
1) There is a risk that someone could get access to the personal information in your
medical records or other information researchers have stored about you.  
2) There is a risk that someone could trace the information in a central database back to
you. Even without your name or other identifiers, your genetic information is unique

Page 17  
to you. The researchers believe the chance that someone will identify you is very
small, but the risk may change in the future as people come up with new ways of
tracing information.  
3)
In some cases, this information could be used to make it harder for you to get or keep
a job or insurance. There are laws against the misuse of genetic information, but they
may not give full protection. There can also be a risk in knowing genetic information.
(Deleted 7/19/16) The Genetic Information Nondiscrimination Act of 2008, also
referred to as GINA, was passed by Congress to protect Americans from such
discrimination. The law prevents discrimination from health insurers and employers.
This law does not cover life insurance, disability insurance and long-term care
insurance. New health information about inherited traits that might affect you or your
blood relatives could be found during a study. The researchers believe the chance
these things will happen is very small, but cannot promise that they will not occur.

You will not benefit from taking part.  
The researchers, using the samples from you and others, might make discoveries that could help
people in the future.
Clinical trial: NCT02785952
Section: Procedures
Subsections: What are the study groups?|What are the study groups?|Who can answer my questions about this study?|WHAT IS INVOLVED?|SAMPLES FOR FUTURE RESEARCH STUDIES:|

You have been assigned to this sub-study because your tumor sample did not have any of the
biomarkers being tested in the other sub-studies or you were not eligible to participate on the
other sub-studies. This sub-study has two study groups (arms). A computer will by chance
assign you to a treatment arm in the study. This is called randomization. This is done by chance
because no one knows if one study arm is better or worse than the other. You have an equal
chance of receiving the study drug or the standard treatment.  
Patients assigned to Arm 1 will receive the study drug nivolumab combined with ipilimumab and
nivolumab will be given via vein over 30 minutes on Day 1 of every 14 day cycle. Ipilimumab
will be given via vein over 60 minutes on Day 1 of every third cycle. A cycle is 14 days.  
Patients assigned to Arm 2 will receive the study drug nivolumab alone, one of the standard
treatments for this cancer. Nivolumab will be given via vein over 30 minutes on Day 1 of every
14 day cycle. A cycle is 14 days.  
The treatments on this study are described in the table below:

Page 6  
Before you begin the study:  
Brain CT or MRI (to check if your cancer may have spread to your brain)
Blood tests to assess your pancreas functions and your levels of hormones coming from
your thyroid.
Questionnaires - You will complete questionnaires in English on how you are feeling
physically and how you are performing your daily activities. You will also be asked
questions about symptoms you may be having. Researchers will use this information to
learn more about how cancer and cancer treatment affects people.  
Brain CT or MRI (to check if your cancer may have spread to your brain)  
Blood tests to assess your pancreas functions and your levels of hormones coming from
your thyroid.  
Questionnaires - You will complete questionnaires in English on how you are feeling
physically and how you are performing your daily activities. You will also be asked
questions about symptoms you may be having. Researchers will use this information to
learn more about how cancer and cancer treatment affects people.  
Note: You might receive the above tests even if you were not on the study as part of your cancer
treatment.  
You will have a CT or MRI done before you begin the study and then approximately every 6
weeks for the first year, then every 3 months until your disease worsens and have completed
treatment. If your disease does not worsen then CT or MRI scans will be collected every 3
months until year 3. After year 3, scans will be taken according to your doctor. Your doctor will
review the CT scans or other radiographic scans done to check on your tumors on a regular basis.
These scans will also be sent to a central location for review. This central review is part of a
total study analysis only. Information of your scans from the central review will not be sent back
to you or your doctor.  
If the exams, tests, and procedures show that you can take part in the study, and you choose to
take part, then you will need the following extra tests. They are not part of the usual approach
for your type of cancer.  
During the study:  
2  
Blood tests to assess your pancreas functions and your levels of hormones coming from
your thyroid.
Questionnaires - You will complete questionnaires in English, on how you are feeling
physically and how you are performing your daily activities. You will also be asked
questions about symptoms you may be having. Researchers will use this information to
learn more about how cancer and cancer treatment affects people.  
Blood tests to assess your pancreas functions and your levels of hormones coming from
your thyroid.  
Questionnaires - You will complete questionnaires in English, on how you are feeling
physically and how you are performing your daily activities. You will also be asked
questions about symptoms you may be having. Researchers will use this information to
learn more about how cancer and cancer treatment affects people.  
The blood test to assess your pancreatic functions will be done before you begin the study and
approximately every 6 weeks. The blood test to assess your levels of hormones coming from
your thyroid will be done before you begin the study and approximately every 6 weeks.  
You will be asked to complete forms before you start the study treatment, at weeks 3, 5, 7, 9, 11,
13, 25, 37, and at the end of years 1, 2, and 3. The forms will take about 15 minutes to
complete. Some questions on the forms will ask about symptoms such as shortness of breath,
itching, and diarrhea; you will also be asked if the symptoms interfere with your daily life. If
you feel uncomfortable answering any of the questions, you can skip any you do not want to
answer.

You can talk to the study doctor about any questions or concerns you have about this study or to
report side effects or injuries. Contact the study doctor
(insert name of
study doctor[s]) at
(insert telephone number).

If you agree to take part, here is what will happen next:  
1) Your specimens may be stored in the Biobank, along with samples from other people
who take part. These specimens may include:
About 1 tablespoon of blood will be collected from a vein in your arm (at the
same time as other study blood tests) on Weeks 3, 7, 9, and again if your
cancer gets worse.
A sample of tissue will be collected from an optional extra biopsy if your
cancer gets worse after treatment on this study. Common side effects of a
biopsy are a small amount of bleeding at the time of the procedure, pain and
bruising at the biopsy site, which can be treated with regular pain medications.
Rarely, an infection can occur. Rarely, patients may experience partial lung
collapse that may require a chest tube or breathing machine. You will sign a
separate consent form before the biopsy is taken. This will be a standard
surgical consent form from the institution where the biopsy procedure takes
place. The samples will be kept until they are used up.
2)
Qualified researchers can submit a request to use the materials stored in the
Biobanks. A science committee at the clinical trials organization, and/or the
National Cancer Institute, will review each request. There will also be an ethics
review to ensure that the request is necessary and proper. Researchers will not be
given your name or any other information that could directly identify you.
3)
Neither you nor your study doctor will be notified when research will be
conducted or given reports or other information about any research that is done
using your samples.
4)
Some of your genetic and health information may be placed in central databases
that may be public, along with information from many other people. Information
that could directly identify you will not be included.  
1) Your specimens may be stored in the Biobank, along with samples from other people
who take part. These specimens may include:  
About 1 tablespoon of blood will be collected from a vein in your arm (at the
same time as other study blood tests) on Weeks 3, 7, 9, and again if your
cancer gets worse.  
A sample of tissue will be collected from an optional extra biopsy if your
cancer gets worse after treatment on this study. Common side effects of a
biopsy are a small amount of bleeding at the time of the procedure, pain and
bruising at the biopsy site, which can be treated with regular pain medications.
Rarely, an infection can occur. Rarely, patients may experience partial lung
collapse that may require a chest tube or breathing machine. You will sign a
separate consent form before the biopsy is taken. This will be a standard
surgical consent form from the institution where the biopsy procedure takes
place. The samples will be kept until they are used up.  
2)
Qualified researchers can submit a request to use the materials stored in the
Biobanks. A science committee at the clinical trials organization, and/or the
National Cancer Institute, will review each request. There will also be an ethics
review to ensure that the request is necessary and proper. Researchers will not be
given your name or any other information that could directly identify you.  
3)
Neither you nor your study doctor will be notified when research will be
conducted or given reports or other information about any research that is done
using your samples.  
4)
Some of your genetic and health information may be placed in central databases
that may be public, along with information from many other people. Information
that could directly identify you will not be included.

with  
1.
If my cancer responds to study treatment, I agree to have another biopsy after
completing study treatment to collect a sample of tissue.
YES
NO
2.
My tumor tissue and related information may be kept in a Biobank for use in future
health research.
YES
NO
3.
My blood samples and related information may be kept in a Biobank for use in
future health research.
YES
NO  
1.
If my cancer responds to study treatment, I agree to have another biopsy after
completing study treatment to collect a sample of tissue.  
YES
NO  
2.
My tumor tissue and related information may be kept in a Biobank for use in future
health research.  
YES
NO  
3.
My blood samples and related information may be kept in a Biobank for use in
future health research.  
YES
NO  
This is the end of the section about optional studies.

|   Arm  | Drug       | How often is it given?    | How is it given?    | What days is it given on?    | What is the cycle duration?    |
|--------|------------|---------------------------|---------------------|------------------------------|--------------------------------|
|     1  | Nivolumab  | Once, every 14 days       | Into a vein         | Day 1                        | 14 days                        |
|     1  | Ipilimumab | Once, every 42 days       | Into a vein         | Day 1 of every third cycle   | 14 days                        |
|     2  | Nivolumab  | Once, every 14 days       | Into a vein         | Day 1                        | 14 days                        |
Clinical trial: NCT02785952
Section: Purpose of Research
Subsections: |What possible benefits can I expect from taking part in this study?|1. Optional Additional Biopsy and Optional Sample Collections for Laboratory Studies and/or Biobanking for Possible Future Studies|1. Optional Additional Biopsy and Optional Sample Collections for Laboratory Studies and/or Biobanking for Possible Future Studies

Page 4  
candidate for a biomarker-matched treatment study. You have been assigned to a
treatment study testing a drug that works with your immune system to fight your
cancer. For this sub-study, you will be assigned to treatment with either nivolumab (the
current standard of care) or to nivolumab combined with ipilimumab (the investigational
therapy). The purpose of this sub-study is to learn if the study drug will improve the
average time to cancer worsening by more than a month. Nivolumab combined with
ipilimumab is investigational for this study. Nivolumab combined with ipilimumab may or
may not shrink your cancer but it could also cause side effects. This study will allow the
researchers to learn any good and bad effects of nivolumab combined with ipilimumab.
There will be about 350 patients taking part in this study.

It is not possible to know at this time if the study drug/study approach is better than the usual
approach, SO this study may or may not help you. This study will help researchers learn things
that will help people in the future.

Researchers are trying to learn more about cancer, diabetes, and other health problems. Much of
this research is done using samples from your tissue, blood, urine, or other fluids. Through these
studies, researchers hope to find new ways to prevent, detect, treat, or cure health problems.

Some of these studies may be about genes. Genes carry information about features that are found
in you and in people who are related to you. Researchers are interested in the way that genes
affect how your body responds to treatment.  
If you choose to take part in this part of the study, the researchers would also like to ask your
permission to store and use your samples and health information for medical research. The
research that may be done is unknown at this time. Storing samples for future studies is called
"biobanking". The Biobank is being run by SWOG and supported by the National Cancer
Institute.
Clinical trial: NCT02785952
Section: Voluntary Participation
Subsections: What are the costs of taking part in this study?|My Signature Agreeing to Take Part in the Main Study

Page 14  
you decide to be in the study, you should check with your health plan or insurance company to
find out exactly what they will pay for.  
You will not be paid for taking part in this study.

I have read this consent form or had it read to me. I have discussed it with the study doctor and
my questions have been answered. I will be given a signed copy of this form. I agree to take part
in the main study and any additional studies where I circled 'yes'.  
Participant's signature
Date of signature
Clinical trial: NCT02785952
Section: Withdrawal from Study
Subsections: Can I stop taking part in this study?|ARE THERE ANY COSTS OR PAYMENTS?

Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important, to let the
study doctor know as soon as possible SO you can stop safely. If you stop, you can decide
whether or not to let the study doctor continue to provide your medical information to the
organization running the study.  
The study doctor will tell you about new information or changes in the study that may affect
your health or your willingness to continue in the study.  
The study doctor may take you out of the study:  
If your health changes and the study is no longer in your best interest
If new information becomes available
If you do not follow the study rules
If the study is stopped by the sponsor, IRB or FDA.  
If your health changes and the study is no longer in your best interest  
If new information becomes available  
If you do not follow the study rules  
If the study is stopped by the sponsor, IRB or FDA.  
What are my rights in this study?  
Taking part in this study is your choice. No matter what decision you make, and even if
your decision changes, there will be no penalty to you. You will not lose medical care or any
legal rights.  
For questions about your rights while in this study, call the
(insert name of center) Institutional Review Board at
(insert telephone
number). (Note to Local Investigator: Contact information for patient representatives or other
individuals at a local institution who are not on the IRB or research team but take calls
regarding clinical trial questions can also be listed here.)

If you decide you no longer want your samples to be used, you can call the study doctor,
,
(insert name of study doctor for main trial) at
(insert telephone number of study doctor for main trial) who will
let the researchers know. Then, any sample that remains in the bank will no longer be used.
Samples or related information that have already been given to or used by researchers will not be
returned.