Clinical trial: NCT03279692
Section: Alternatives
Subsections: C.  What Other Options Are There?

Taking part in this research study is voluntary. Instead of being in this research study, you have other options which may include the following:  
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Receive no therapy specific to your cancer.  
Comfort care, also called palliative care.  This type of care may help to reduce pain, tiredness, appetite problems and other problems caused by the cancer.  It does not treat the cancer directly, but instead tries to treat the symptoms.
Please talk to the research doctor about your options before you decide whether you will take part in this research study.  
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Receive standard treatment including radiation or surgery Take part in another research study.
Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017
Clinical trial: NCT03279692
Section: Confidentiality
Subsections: L.  What About Confidentiality?|O.  Privacy Of Protected Health Information|2. Why Will Protected Information About Me Be Used Or Shared With Others?|3. Who Will Use Or Share Protected Health Information About Me?|4. With Whom Outside Of Df/Hcc May My Protected Health Information Be Shared?|5. For How Long Will Protected Health Information About Me Be Used Or Shared With Others?

We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of study data.  
Medical information created by this research study may become part of your hospital medical record and may be forwarded to your primary doctor.  
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Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017 Information that does not become part of your medical record will be stored in your study file.  It may also become part of a DF/HCC research database.  
The results of this research study may be published. You will not be identified in publications without your permission.  
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.

Federal law requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its affiliated research doctors, health care providers, and physician network to protect the privacy of information that identifies you and relates to your past.  
present, and future physical and mental health conditions ("protected health information").  If you enroll in this research study, your "protected health information" will be used and shared with others as explained below.

The main reasons include the following:
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To conduct and oversee the research described earlier in this form; To ensure the research meets legal, institutional, and accreditation requirements;
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To conduct public health activities (including reporting of adverse events or situations where you or others may be at risk of harm); and
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Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017 To provide the study sponsor with information arising from an adverse
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event or other event that relates to the safety or toxicity of the drug(s)
used in the study and for the purpose of this or other research relating the study drug(s) and their use in cancer; To better understand the diseases being studied and to improve the
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design of future studies; and, Other reasons may include for treatment, payment, or health care
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operations.  For example, some medical information produced by this research study may become part of your hospital medical record because the information may be necessary for your medical care. (You will also be given a notice for use and sharing of protected health information.)

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DF/HCC and its affiliated research doctors and entities participating in the research will use and share your protected health information.  In addition, other DF/HCC offices that deal with research oversight, billing or quality assurance will be able to use and share your protected health information.

While all reasonable efforts will be made to protect the confidentiality of your protected health information, it may also be shared with the following entities:
Outside individuals or entities that have a need to access this information
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to perform functions relating to the conduct of this research such as analysis by outside laboratories on behalf of DF/HCC and its affiliates (for example, data storage companies, insurers, or legal advisors).  
The sponsor of the study, its subcontractors, representatives, business,
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partners, and its agent(s): DF/HCC
The funder of the study, its subcontractors, representatives, business
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partners, and its agent(s): Merck Other research doctors and medical centers participating in this research,
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if applicable Federal and state agencies (for example, the Department of Health and
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Human Services, the Food and Drug Administration, the National Institutes of Health, and/or the Office for Human Research Protections), or other domestic or foreign government bodies if required by law and/or Page 14 of 18  
Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017
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necessary for oversight purposes. A qualified representative of the FDA
and the National Cancer Institute may review your medical records.  
Hospital accrediting agencies A data safety monitoring board organized to oversee this research, if applicable Some who may receive your protected health information may not have to satisfy the privacy rules and requirements.  They, in fact, may share your information with others without your permission.

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There is no scheduled date at which your protected health information that is being used or shared for this research will be destroyed, because research is an ongoing process.
Clinical trial: NCT03279692
Section: Duration of Study Involvement
Subsections: E.  How Long Will I Be In This Research Study?

You will be in this research study for as long as you are responding to and tolerating treatment.  
You may be taken off the research study drug for many reasons including if:
It is considered to be in your best interest
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The study treatment or procedures are found to be unsafe or ineffective.  
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There is any problem with following study treatments and procedures
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You are a female and become pregnant or plan to become pregnant Page 4 of 18  
| Treatment Cycles               | End of    |           |    |    |    |    |    |
|--------------------------------|-----------|-----------|----|----|----|----|----|
| To be repeated beyond 8 cycles | Follow-Up |           |    |    |    |    |    |
| 3                              | 4         | Treatment |    |    |    |    |    |
| 5                              | 6         | 8         |    |    |    |    |    |
| x                              | x         | x         | x  | x  | x  | x  | x  |
| x                              | x         | x         | x  | x  | x  | x  | x  |
| x                              | x         | x         | x  |    |    |    |    |
| x                              | x         | x         | x  | x  | x  | x  |    |
| x                              | x         | x         | x  | x  | x  |    |    |  
Approved Date (DFCI IRB Approval): 01/24/2023  
Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates  
Your condition worsens
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A decision is made to close the study
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Or for other unforeseen reasons that make it necessary to stop your
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participation in the research study
If you are removed from the research study, the research doctor will explain to you why you were removed.  
In addition, you can stop participating in the research study at any time, however, the FDA requires that any information collected up to the point of your withdrawal cannot be removed from the study.  If you decide to stop participating in this research study, we encourage you to talk to the research doctor and your primary doctor first.
Clinical trial: NCT03279692
Section: Participant's Rights
Subsections: 6. Statement Of Privacy Rights:

You have the right to withdraw your permission for the research doctors
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and participating DF/HCC entities to use or share your protected health information.  We will not be able to withdraw all the information that already has been used or shared with others to carry out related activities such as oversight, or that is needed to ensure quality of the study. To withdraw your permission, you must do so in writing by contacting the researcher listed above in the section: "Whom do I contact if I have questions about the research study?'
You have the right to request access to your protected health information
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that is used or shared during this research and that is related to your treatment or payment for your treatment, but you may access this information only after the study is completed.  To request this information, please contact the researcher listed above in the section: "Whom do l contact if I have questions about the research study?"
Research Consent Form for Biomedical Research Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017
Clinical trial: NCT03279692
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: F.  What Are The Risks Or Discomforts Of The Research Study?|Risks Associated With Pembrolizumab: Very Common (At Least 20% Chance That This Will Happen): Itching Of The Skin .|Common (Between A 10-20% Chance That This Will Happen):|Rare But Serious Immune-Mediated Side Effects (1% Or Less Chance That This Will Happen):|Risks Associated With Mri Scans:|Risks Associated With Contrast Agents Used During Scans:|Reproductive Risks:|Non-Physical Risks:|K.  What Happens If I Am Injured Or Become Sick Because I Took Part In This Research Study?

There are risks to taking part in any research study. One risk is that you may get a study drug that does not help treat your disease or that makes your condition or disease worse.  Another risk is that there may be side effects.  
All cancer treatments can have side effects, which can range from mild and reversible to severe, long lasting and possibly life-threatening.  There is a great deal of variability among side effects of different cancer treatments and between individuals.  In a research study, all of the risks or side effects may not be known before you start the study. You need to tell your doctor or a member of the study team immediately if you experience any side effects.  
Everyone in the research study will be watched carefully for side effects.  You will be monitored during the administration of study drugs to keep track of your blood counts and organ function, particularly your kidney and liver function.  If you experience side effects, they may go away after you stop taking the study drug.  
Some side effects can be mild; but others can be long lasting and may never go away.  Some may be life-threatening or fatal.  
Since the effect of the study drug(s) taken with other medications may not be known, it is important that you tell the research doctor about all prescription and non-prescription drugs, herbal preparations and nutritional supplements that you are taking or planning to take. There may also be some foods that you should Page 5 of 18  
Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017 avoid while on this research study and your research doctor will review this information with you.  
During the research study, you will be notified of newly discovered side effects or significant findings, which may affect your health or willingness to participate.  
You may be asked to sign a new consent form that shows that you have been informed of new information relating to this research study.

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Diarrhea (this may be associated with a more serious inflammatory condition)
Cough (this may be associated with a more serious inflammatory condition)
Rash Fatigue
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Joint pain Fever. This may be serious or life threatening.  
Back pain Occasional (between a 1% to a 10% chance that this will happen):
Too little thyroid hormone that controls how the body uses energy
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which may cause you to feel tired, gain weight, feel cold, and have infrequent or hard bowel movements.  This may manifest as a serious immune-mediated side effect in 1% or fewer patients. (hypothyroidism) Too much thyroid hormone that controls how the body uses energy
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which may cause you to feel anxious, angry, weak, and tired, and may cause trembling, weight loss, hair loss, increased sweating, diarrhea, and difficulty sleeping.  This may manifest as a serious immunemediated side effect in 1% or fewer patients. (hyperthyroidism)
Inflammation of the lungs which may cause shortness of breath and
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cough.  This may manifest as serious in 1% to 4% of patients and there is a rare chance that this may become life threatening. (pneumonitis)
Inflammation of the large intestine (bowels/gut) which may cause
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stomach pain with loose or watery stools. This might manifest as serious in 1% to 4% of patients. (colitis)
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Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017
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Inflammation of the skin so you may have peeling of the skin, itching, and skin redness. In 1% or fewer patients this may cause widespread.  
peeling of the skin. Rarely, this might become severe and life threatening, and involve the inside of the mouth, surface of the eye and genital area and/or may cause the top layer of your skin to peel from all over your body which can cause severe infection. (Stevens Johnsons Syndrome)
Stomach cramps, pain in the abdomen due to cramping Loss of skin color and hair color (vitiligo)
Low levels of salt in the blood, which can cause confusion, headaches, fatigue, muscle cramps, and make you feel sick to your stomach.  
Dizziness or fainting (low blood pressure), flushing, rash, fever, shortness of breath or sick to your stomach at the time of receiving your infusion (IV) or just after, or pain at the site of infusion. This may manifest as serious in less than 1% of patients and there is a rare chance that this may become life threatening.  
Arthritis, which is swelling of the joints.

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Inflammation of the liver which may cause you to feel not hungry, tired, have a mild fever, muscle or joint aches, nausea and vomiting, stomach pain, yellow eyes and skin, and dark urine. This may become serious or life threatening (hepatitis)
Inflammation of the pituitary gland which may cause headaches, stomach discomfort, change in eyesight (double vision), change in behavior, few to no menstrual cycles (for women), weakness, vomiting, and dizziness or fainting (hypophysitis)
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Inflammation of the glands on top of the kidneys (adrenal glands) leading to insufficient hormone production causing tiredness, weight loss, muscle weakness, feeling faint, joint, muscle and abdominal aches, nausea, vomiting, loose or watery stools, fever, salt craving, and sometimes darkening of the skin like a suntan Inflammation of the kidney which may cause you to pass less urine, have cloudy urine, have blood in your urine, have swelling and lower back pain Inflammation of the muscles which may cause weakness or pain in the muscles
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Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017
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Inflammation of the pancreas causing pain in the upper abdomen. This could cause nausea and vomiting that gets worse when you eat. (pancreatitis)
Inflammation of the eye causing redness of the eye, blurred vision, sensitive to light, eye pain, see floaters or have headaches (uveitis)
A condition when you may have too much sugar in your blood, may feel thirsty, and are likely to need regular insulin shots for treatment
(diabetes).  
Inflammation of the nerves that may cause pain, weakness or tingling in the hands and feet, and may spread to the legs, arms, upper body leading to severe muscle weakness and possible temporary paralysis.  
This may become serious or life threatening.  
Inflammation of the heart muscle (myocarditis) that may cause your heart to have difficulty pumping blood throughout your body. This may cause chest pain, shortness of breath, and swelling of the legs. You may experience a fast or irregular heart rate causing dizziness or fainting.  This might become severe, require hospitalization, and sometimes this condition can lead to death.  
A condition where you will feel weakness and fatigue of your hip and thigh muscles and an aching back caused by your body's immune system attacking your healthy cells and tissues. (polymyositis)
Inflammation of the stomach and/or intestines which may result in bleeding, diarrhea, and perforations. This may be serious or life threatening. (gastroenteritis)
Some drug reactions can rarely be fatal and may occur even after discontinuation of pembrolizumab therapy.  
Cancer research often includes biopsies, scans, x-rays that are also provided as routine care.  The following describes the side effects of procedures done only for the purposes of research.

When having an MRI (Magnetic Resonance Imaging) scan, you will lie still on a table that slides into a tunnel slightly wider than your body. People who feel uncomfortable in confined spaces (claustrophobia) may feel uncomfortable in the narrow cylinder. If you feel uncomfortable in confined spaces, please tell your research doctor. Your doctor may give you a medication to make you feel more comfortable. As images are taken, a loud banging noise will be produced.  
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Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017 Earplugs or headphones will be available if needed. The MRI can be stopped at any time at your request, but the scan may not be complete.

There is a small risk with using a contrast agent that is injected into a vein during the MRI.  The contrast agent is a special dye that highlights organs, blood vessels or tissue to make them more visible.  Depending on the type of contrast agent that is used, it may cause decreased kidney function or worsen kidney function in people who already have decreased kidney function.  Therefore, we will monitor your kidney function closely while you participate in this study.  If there is any change in your kidney function, we may have to remove you from the study.  
Uncommonly, some people have allergic reactions (such as hives and itching) to the contrast agent.  Serious reactions (for example, drop in blood pressure, difficulty breathing or severe allergic reaction and death) are rare.

The drug used in this research study may affect a fetus.  While participating in this research study and for 4 months after, you should not become pregnant or father a baby, and should not nurse a baby.  We can provide counseling about preventing pregnancy for either male or female study participants. Let your doctor know immediately if you become pregnant or find out that you are going to be the father of a child.

Because of side effects or the time required for tests and clinic visits while you are on this research study, you may be unable to keep up with your normal daily activities.

If you think you have been injured as a result of taking part in this research study, tell the person in charge of this research study as soon as possible.  The research doctor's name and phone number are listed in this consent form.  
The treating hospital will offer you the care needed to treat injuries directly resulting from taking part in this research.  These treatments will be billed to your insurance company. You will be responsible for deductibles and co-payments.  
There are no plans to pay you or give you other compensation for the injury. You do not give up your legal rights by signing this form.  
We will need to collect certain personal information about you for insurance or payment reporting purposes, such as your name, date of birth, gender, social security number or Medicare identification number and information related to this research study. We may be required to report this information to the Centers for Medicare & Medicaid Services. We will not use this information for any other purpose.
Clinical trial: NCT03279692
Section: Procedures
Subsections: D.  What Is Involved In The Research Study?

Sometimes it is hard to keep track of all of the details and procedures that are part of a research study.  We will describe them in this consent form and you can refer to this at any time during the research study.
Clinical trial: NCT03279692
Section: Purpose of Research
Subsections: B.  Why Is This Research Study Being Done?

This research study is a Phase II clinical trial.  Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease.  "Investigational" means that the drug is being studied.  
The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for your specific disease but it has been approved for other uses.  
In this research study, we are studying pembrolizumab in participants with meningioma. Research studies have shown that meningioma tumor cells express a gene called PD-L1. We will be looking to determine whether the study drug may stop this gene from being activated on your tumor and whether the study drug may stop the tumor cells from growing.
Clinical trial: NCT03279692
Section: Voluntary Participation
Subsections: P. D Ocumentation Of C Onsent

My signature below indicates:
I have had enough time to read the consent and think about
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participating in this study; I have had all of my questions answered to my satisfaction;
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l am willing to participate in this study; I have been told that my participation is voluntary and I can withdraw at
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any time Signature of Participant or Legally Authorized Representative Date Relationship of Legally Authorized Representative to Participant Page 16 of 18  
Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017
Clinical trial: NCT03279692
Section: Withdrawal from Study
Subsections: H.  Can I Stop Being In The Research Study And What Are My Rights?

You have the right to choose not to sign this form.  If you decide not to sign this form, you cannot participate in this research study.  
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Dana-Farber/ Harvard Cancer Center BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 02.03.2017 You can stop being in the research study at any time.  Tell the research doctor if you are thinking about stopping or decide to stop.  He or she will tell you how to stop.  Leaving the research study will not affect your medical care outside of the research study.  
If you choose not to participate, are not eligible to participate, or withdraw from this research study, this will not affect your present or future care and will not cause any penalty or loss of benefits to which you are otherwise entitled.  
It is important to tell the research doctor if you are thinking about stopping so your research doctor can evaluate the risks from stopping the drug. Another reason to tell your research doctor that you are thinking about stopping is to discuss what follow-up care and testing could be most helpful for you.