Clinical trial: NCT04823624
Section: Alternatives
Subsections: 6. Will Being In This Study Benefit Me In Any Way?

We do not know if taking part in this study will benefit you. This study may help researchers learn information that could help people in the future.
Clinical trial: NCT04823624
Section: Confidentiality
Subsections: L. Future Use Of Data And Specimens|M. Confidentiality|P. Privacy Of Protected Health Information (Hipaa Authorization)|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?

Your personal information and/or biospecimens collected during this study may be stored and used for future research. Any personal identifiers will be removed, Page 14 of 21 before they are shared, so that the information or samples cannot be linked back to you. Investigators, including investigators from collaborating institutions, can request this data and samples for new research. Samples and data may also be shared with outside non-profit academic investigators as well as with for-profit pharmaceutical investigators or commercial entities, with whom we collaborate. You will not be asked to provide additional informed consent for the use of your identifiable information or samples in future research. Future research studies may include genetic research. Your genes are unique to you. At this time, you cannot be identified through this research, if the samples and specimens are de-identified. There is a risk that you might be reidentified in the future as genetic research progresses

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. Information that does not become part of your medical record will be stored in your study file. It may also become part of a research database. Participation in this study involves providing a specimen of your tissue; please know that if the research doctor leaves the institution, the research and the tissue might remain at the research doctor's current institute or might be transferred to another institution. The study team plans to publish the results of this research study and when we do, we may be asked to make the data we collect available to other researchers. We will not include information that identifies you in any publications or to the researchers who request the data to do additional research. Your de-identified specimens or genetic data may also be placed into one or more publicly-accessible scientific databases. Through such databases, researchers from around the world will have access to de-identified samples or data for future research.  
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BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS Version: 1.31.2020 There is a risk that deidentified research data that is shared with outside collaborators may be reidentified. When deidentified data and specimens are shared with outside collaborators agreements limit what the outside collaborators can do with the information to help prevent reidentification.

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its affiliated research doctors, health care providers, and physician network to protect the Page 16 of 21 BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS Version: 1.31.2020 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:
To conduct and oversee the research described earlier in this form; To ensure the research meets legal, institutional, and accreditation requirements; To conduct public health activities (including reporting of adverse events or situations where you or others may be at risk of harm); and To provide the study sponsor with information arising from an adverse 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 design of future studies; and, Other reasons may include for treatment, payment, or health care 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.)

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 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(s) of the study, its subcontractors, representatives, business partners, and its agent(s): DF/HCC
Other research doctors and medical centers participating in this research, if applicable Federal and state agencies (for example, the Department of Health and 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 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 Other, the funder(s) of the study, its subcontractors, representatives, business partners, and its agent(s): Novartis 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.

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: NCT04823624
Section: Duration of Study Involvement
Subsections: 4. What Does This Research Study Involve And How Long Will It Last?|Planned Follow-Up:

The name of the study drug involved in this study is MBG453.  
Page 1 of 21 The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits. You will receive study treatment for as long as you and your doctor believe you are benefiting from the study drug. You will then be followed for 12 months after your last dose of the study drug or until you withdraw your consent to be contacted. It is expected that about 20 people will take part in this research study. Information about you and your health is personal and private. Generally, it cannot be obtained without your written permission. By signing this form, you are providing that permission and your information may be obtained and used in accordance with this informed consent and as required or allowed by law. This means that researchers may obtain information regarding your past medical history, as well as specimens and samples from previous health care providers such as hospitals and labs.

We would like to keep track of your medical condition. Follow-up will be for 12 months from the last dose of the study drug. This will occur at approximately 30, 150, and 250 days after the last dose, and roughly 12 months from the last dose, and will be done in person or via phone/electronically. Keeping in touch with you and checking your condition helps us look at the long-term effects of the research study. 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.  
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Clinical trial: NCT04823624
Section: Participant's Rights
Subsections: 6. Statement Of Privacy Rights:

You have the right to withdraw your permission for the research doctors and participating DF/HCC entities to use or share your protected health information. We will not be able to withdraw all the information that Page 18 of 21 BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS Version: 1.31.2020 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 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 I contact if I have questions about the research study?"
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 BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS Version: 1.31.2020
Clinical trial: NCT04823624
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 5. What Are The Risks To Participating In This Study?|C. What Are The Risks Or Discomforts Of The Research Study?|Risks Associated With Mbg453: Occasional (More Than A 5% Chance That This Will Happen): Constipation Abnormal Physical Weakness Or Lack Of Energy Fatigue Vomiting|Risks Associated With Bone Marrow Biopsies/Aspirations:|Reproductive Risks:|Non-Physical Risks:|E. What Are The Benefits Of This Research Study?|H. 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. We want to make sure you know about a few key risks right now. There may also be rare, serious and potentially life-threatening side effects. More detailed information is provided in the "What are the risks or discomforts of the research study?" section. There is a risk that you could have side effects from the MBG453. These side effects may be worse and may be different than you would get with other approaches for your cancer. Some of the most common side effects (happening in 10-30% of patients) that the study doctors know about are:
Fatigue Headache Nausea Constipation Decreased appetite Shortness of breath Abdominal Pain Vomiting Diarrhea Joint aches Page 2 of 21  
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS Version: 1.31.2020 Low number of red blood cells, which may cause fatigue or shortness of breath Low number of platelets, which may increase the risk of bleeding Low number of white blood cells, which may be a risk for infections such as pneumonia (infection of the lungs) or urinary tract infections.  
Fever, which may occur at the same time that the white blood cell count is low and require administration of antibiotics or admission to the hospital Swelling of the legs and ankles Dizziness

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 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.

Rare (Less than a 5% chance that this will happen):
Page 9 of 21 Joint pain Cough Skin irritation (Dermatitis) - possible symptoms include rash, itching, dry, cracked, or scaly skin, and swelling, burning or tenderness. This may require treatment with a topical medication or cream. Rarely it could require systemic treatment with a steroid.  
Dry skin Difficulty breathing Hypomagnesaemia or low levels of magnesium in the blood which could cause weakness and muscle cramping. Rarely heart rhythm abnormalities may occur. To treat this, you may need to get either oral or intravenous magnesium to replace these levels.  
Lethargy (fatigue/sleepiness)
Chest pain Fluid in the lungs. Possible symptoms include wheezing or gasping for breath, difficulty breathing, and extreme shortness of breath that worsens with activity or when lying down. This can be dangerous if not evaluated and treated.  
Stomatitis or inflammation of the mucous membrane of the mouth which may be painful and cause difficulty swallowing.  
Abnormally rapid heart rate

For this procedure, a numbing drug is injected into the skin over one of your hipbones. A needle is then inserted into the hipbones and a small piece of bone is removed (biopsy) or a sample of the bone marrow is removed (aspiration). The risks may include:
Moderate pain and discomfort Bleeding at the biopsy/aspiration site Scarring at the biopsy/aspiration site Rarely, an infection at the biopsy/aspiration site Rarely, nerve injury at the biopsy/aspiration site

The drugs used in this research study may affect a fetus. While participating in this research study, and for at least 5 months after the last dose of the study drug, you should not:
become pregnant nurse a baby father a baby Page 10 of 21  
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS Version: 1.31.2020 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. If your partner becomes pregnant while you are on the study, it may be critical to share information regarding your participation in this research study with that person. Your research doctor should also be told if this happens.

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.

Taking part in this research study may or may not benefit you. We hope the information learned from this research study will provide more information about MBG453 and its effects on your disease.

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 may be billed to you or your insurance company. You will be responsible for deductibles, copayments and co-insurance. 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. If you go to the Emergency Room or to another hospital or doctor it is important that you tell them that you are in this research. If possible, you should give them a copy of this consent form.  
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Clinical trial: NCT04823624
Section: Procedures
Subsections: B. What Is Involved In The Research Study? Before The Research Starts (Screening):|Additional Research Procedures To Be Performed At The Time Of Screening But Not Required To Determine Eligibility: Bone Marrow Biopsy And/Or Aspirate, To Evaluate The Extent Of Your|Study Treatment Overview:|Study Visit (Cycle 1 Days 8, 15, And 22): This Visit Will Involve The Following:|Study Visit (End Of Treatment):|Research Study Plan:

After signing this consent form, you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated.  
**A medical history,** which includes questions about your demographics, health, current medications, and any allergies.  
**Physical Examination,** including the following:
Height/Weight/Body Surface Area Measurements. Height will only be measured at screening.  
Blood Pressure
**Laboratory Tests,** approximately 10 teaspoons/tablespoons of blood will be collected for the following purposes:
Routine clinical purposes, including a pregnancy test if you are a woman of childbearing potential.  
Research testing.  
**Electrocardiogram (ECG),** which measures your heart's electrical activity.  
**Measurement of vital signs,** which includes body temperature, pulse rate, and breathing rate.  
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**Performance Status**, which evaluates how you are able to carry on with your usual activities.  
If these tests show that you are eligible to participate in the research study, you may begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.

disease. For this test, a sample of bone marrow cells is taken by a needle inserted into a bone in your body. If a bone marrow biopsy is needed, a small piece of bone and the attached bone marrow is removed. These tests may be done under local anesthesia.

**Infused Study Drug:** Each study treatment cycle last for 28 days (4 weeks) during this time you will be given MBG453 On Day 1 of each cycle into your vein (by intravenous infusion) over about 30 minutes. This will continue for as long as you are on the study.

**Medical History.**
**Laboratory Test,** blood samples will be collected for routine clinical purposes.  
**Vital Signs Measurement.**  
Page 5 of 21 BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS Version: 1.31.2020 This visit will involve the following:
**MBG453 infusion.**
**Medical History.** **Physical Exam.** **Laboratory Test,** blood samples will be collected for routine clinical purposes.  
**Vital Signs Measurement.** **Performance Status.** ECG
Study Visit (Cycle 2 Days 8, 15, and 22): This visit will involve the following:
**Medical History.**
**Laboratory Test,** blood samples will be collected for routine clinical purposes.  
Vital Signs Measurement  
This visit will involve the following:
**MBG453 infusion.** **Medical History.**
**Physical Exam.** **Laboratory Test,** blood samples will be collected for routine clinical purposes.  
ECG **Vital Signs Measurement.**
**Performance Status.**
**Bone Marrow Biopsy/Aspirate** which will be used for analysis.  
This visit will involve the following:
**Medical History.** **Laboratory Test,** blood samples will be collected for routine clinical purposes.  
**Vital Signs Measurement.**
Study Visit (Cycle 4 Day 1): This visit will involve the following:
**MBG453 infusion.** **Medical History.**
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**Physical Exam.**  
 **Laboratory Test,** blood samples will be collected for routine clinical purposes.  
ECG **Vital Signs Measurement.** **Performance Status.**  
This visit will involve the following:
**Medical History.**
**Laboratory Test,** blood samples will be collected for routine clinical purposes.  
Vital Signs Measurement  
These visits will involve the following:
**MBG453 infusion.**
**Medical History.** **Physical Exam.**
**Laboratory Test,** blood samples will be collected for routine clinical purposes.  
**Vital Signs Measurement.** **Performance Status.**
ECG
**Bone Marrow Biopsy,** which will be used for analysis.

This visit will occur 30 days after your last dose of the study drug and will involve the following:
**Medical History.** **Physical Exam.**
**Laboratory Test,** blood samples will be collected for routine clinical purposes.  
**Vital Signs Measurement**
ECG
**Bone Marrow Biopsy,** which will be used for analysis.  
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| Cycle 1                   | Cycle 2   | Cycles 3                | Cycle 4   | Cycle   | End of   |     |     |     |     |    |                           |    |    |    |    |
|---------------------------|-----------|-------------------------|-----------|---------|----------|-----|-----|-----|-----|----|---------------------------|----|----|----|----|
| 5+                        | Treatment |                         |           |         |          |     |     |     |     |    |                           |    |    |    |    |
| Screening                 | Day       | Day  Day  Day  Day  Day | Day       | Day  22 | Day 1    | Day | Day | Day | Day |    |                           |    |    |    |    |
| 1                         | 8         | 15                      | 22        | 1       | 8        | 15  | 15  | 1   | 15  | 1  | 30 days  after last  dose |    |    |    |    |
| MBG453                    | X         | X                       | X         | X       | X        |     |     |     |     |    |                           |    |    |    |    |
| Medical  History          | X         | X                       | X         | X       | X        | X   | X   | X   | X   | X  | X                         | X  | X  | X  | X  |
| Physical  Exam            | X         | X                       | X         | X       | X        | X   | X   |     |     |    |                           |    |    |    |    |
| Laboratory  Test          | X         | X                       | X         | X       | X        | X   | X   | X   | X   | X  | X                         | X  | X  | X  | X  |
| Vital Signs               | X         | X                       | X         | X       | X        | X   | X   | X   | X   | X  | X                         | X  | X  | X  | X  |
| Performance  Status       | X         | X                       | X         | X       | X        |     |     |     |     |    |                           |    |    |    |    |
| ECG                       | X         | X                       | X         | X       | X        | X   | X   |     |     |    |                           |    |    |    |    |
| Bone Marrow  Biopsy/Aspir | X         | X                       | X         | X       |          |     |     |     |     |    |                           |    |    |    |    |
| ate                       |           |                         |           |         |          |     |     |     |     |    |                           |    |    |    |    |
Clinical trial: NCT04823624
Section: Purpose of Research
Subsections: A. 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 U.S. Food and Drug Administration (FDA) has not approved MBG453 for your specific disease but it has been approved for other uses. The study drug (MBG453) may interact with TIM-3 (an antibody which is a protein that attaches to foreign infectious/invading cells and signals the immune system) which might aid the immune system's (system in your body that fights against diseases) response by helping immune cells recognize, find, and destroy cancer cells in the body.
Clinical trial: NCT04823624
Section: Voluntary Participation
Subsections: Main Consent|Q. Documentation Of Consent

I**NTRODUCTION AND KEY INFORMATION**
All research is voluntary. It is your choice whether you take part in this research or not. If you decide to participate, please sign and date at the end of this form. We will give you a copy and you can refer to this consent form at any time. The following is a short summary of this research study to help you decide whether you would like to be a part of this study. More detailed information is provided later in this form. For purposes of this research, you will be referred to as a "participant."

My signature below indicates:
I have had enough time to read the consent and think about participating in this study; I have had all of my questions answered to my satisfaction; I am willing to participate in this study; I have been told that my participation is voluntary and I can withdraw at any time Signature of Participant Date or Legally Authorized Representative Relationship of Legally Authorized Representative to Participant Page 20 of 21  
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS Version: 1.31.2020 To be completed by person obtaining consent:
Clinical trial: NCT04823624
Section: Withdrawal from Study
Subsections: D. What Will Happen If I Am Removed From The Study Or Decide To End My Participation In The Research?

You can also choose to stop participating 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. 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 study drug. It is important to note that although you may withdraw from study participation, the FDA requires that any information collected up to the point of your withdrawal cannot be removed from study records. Additionally, the research doctor may consult public records after you have withdrawn from the study.  
You may be taken off the research study for any reason including:
It is considered to be in your best interest The study treatment or procedures are found to be unsafe or ineffective There is any problem with following study treatments and procedures You are a female and become pregnant or plan to become pregnant Your condition worsens A decision is made to end the study Or for other unforeseen reasons that make it necessary to stop your participation in the research study