Clinical trial: NCT03391232
Section: Alternatives
Subsections: 10. What Alternative Do You Have If You Choose Not To Participate In This Research Study?

Vaccination with PolyPEPI1018 is not alternative to any standard treatment, but in addition to standard treatment. If you decide not to participate in this study, you may still receive the standard treatment(s) for your metastatic colorectal cancer. Your study doctor will discuss these options with you.
Clinical trial: NCT03391232
Section: Confidentiality
Subsections: Research Participant Consent And Privacy Authorization Form|14. How Will Your Privacy And The Confidentiality Of Your Records Be Protected?|Why Will This Information Be Used And/Or Given To Others?|With Whom May Your Health Information Be Shared?|Is Your Health Information Protected After It Has Been Shared With Others?

Study Title: OBERTO-101, A Phase 1, Multiple dose, Multicenter, Open-label Study to Evaluate Safety, Tolerability and Immunogenicity of Subcutaneous Injection of PolyPEPI1018 Vaccine as an Add-on Immunotherapy to the Standard-of-Care Maintenance Therapy in Subjects with Metastatic Colorectal Cancer (OBERTO) IRB\#: 18-000848 Principal Investigator: Joleen Hubbard, M.D., and Colleagues Please read this information carefully. It tells you important things about this research study. A member of our research team will talk to you about taking part in this research study. If you have questions at any time, please ask us. Take your time to decide. Feel free to discuss the study with your family, friends, and healthcare provider before you make your decision.  
To help you decide if you want to take part in this study, you should know:
Taking part in this study is completely voluntary.  
You can choose not to participate.  
You are free to change your mind at any time if you choose to participate.  
Your decision won't cause any penalties or loss of benefits to which you're otherwise entitled.  
Your decision won't change the access to medical care you get at Mayo Clinic now or in the future if you choose not to participate or discontinue your participation.
For purposes of this form, Mayo Clinic refers to Mayo Clinic in Arizona, Florida and Rochester, Minnesota; Mayo Clinic Health System; and all owned and affiliated clinics, hospitals, and entities. If you decide to take part in this research study, you will sign this consent form to show that you want to take part. We will give you a copy of this signed and dated form to keep. A copy of this form will be put in your medical record.

Mayo Clinic is committed to protecting the confidentiality of information obtained about you in connection with this research study. To protect the data and confidentiality of your data, a code will be used as an identifier. The code will be a registration number assigned specifically to you by the Mayo Clinic Cancer Center Registration Office or Study Sponsor, if applicable. The correlating Mayo Clinic number and your name for reference will be maintained in a secure database accessible by Mayo Clinic assigned research staff.

To do the research.  
To report the results.  
To see if the research was done correctly.  
If the results of this study are made public, information that identifies you will not be used.

The Mayo Clinic Institutional Review Board that oversees the research.  
Other Mayo Clinic physicians involved in your clinical care.  
Researchers involved in this study at other institutions. Federal and State agencies (such as the Food and Drug Administration, the Department of Health and Human Services, the National Institutes of Health and other United States agencies) or government agencies in other countries that oversee or review research.  
The sponsor(s) of this study and the people or groups it hires to help perform this research.  
A group that oversees the data (study information) and safety of this research.

Mayo Clinic asks anyone who receives your health information from us to protect your privacy; however, once your information is shared outside Mayo Clinic, we cannot promise that it will remain private and it may no longer be protected by the Privacy Rule. The study data may be transferred to other countries for processing, including countries not covered by data protection legislation. The laws of your state may provide further protection.
Clinical trial: NCT03391232
Section: Duration of Study Involvement
Subsections: 4. How Long Will You Be In This Research Study?

If you decide to participate in this study, you will be asked to make a total of 16 visits to the study site over the next approximately 41 weeks. If you have participated in the first part of the OBERTO study and have already signed the informed consent for a single-dose vaccination, by signing the present informed consent form you accept to roll over into the present, multiple doses study and complete a total of 16 visits. You do not need to start over again, you will just continue from your last visit (for example, if you have already completed Visit 6 you will start from Visit 7).
Clinical trial: NCT03391232
Section: Participant Responsibilities
Subsections: What Is Expected From You?|11. What Tests Or Procedures Will You Need To Pay For If You Take Part In This Research Study?|12. Will You Be Paid For Taking Part In This Research Study?

When deciding whether to participate, consider whether you are able and willing:
To follow the study rules To commit the time required to keep appointments To tell the study doctor truthfully about your complete medical history To report any new problems, illnesses, or changes in medication during the study To complete the study diary and return it at your scheduled visits

You won't need to pay for tests and procedures which are done just for this research study. These tests and procedures are:
Study Vaccine PolyPEPI1018 and its administration Physical exams Blood and urine tests performed for this study Tumor Biopsy CT Imaging Buccal swab Pregnancy Testing (if applicable)
However, you and/or your insurance will need to pay for all other tests and procedures that you would have as part of your clinical care. You will also be responsible for any co-payments and deductibles. If you have billing or insurance questions call Research Billing at the telephone number provided in the Contact Information section of this form.

You may be reimbursed, up to $39 per visit, for any reasonable travel expenses (bus/train/taxi fares) incurred as a result of taking part in this study on production of a receipt.
Clinical trial: NCT03391232
Section: Participant's Rights
Subsections: Your Privacy Rights

You do not have to sign this form, but if you do not, you cannot take part in this research study. While the study is in progress, your access to your study records will be temporarily suspended. You will be able to access your information when the research study is completed. You have the right to see and copy the medical information collected from you in the course of the study for as long as that information is maintained by the study personnel and other entities subject to federal privacy regulation.  
If you cancel your permission to use or share your health information, your participation in this study will end and no more information about you will be collected; however, information already collected about you in the study may continue to be used. If you choose not to take part or if you withdraw from this study, it will not harm your relationship with your own doctors or with Mayo Clinic. You can cancel your permission to use or share your health information at any time by sending a letter to the address below: Mayo Clinic Office for Human Research Protection ATTN: Notice of Revocation of Authorization 201 Building 4-60 200 1st Street SW Rochester, MN 55905 Alternatively, you may cancel your permission by emailing the Mayo Clinic Research Subject Advocate at: researchsubjectadvocate@mayo.edu. Please be sure to include in your letter or email:
The name of the Principal Investigator, The study IRB number and /or study name, and Your contact information.  
Your permission lasts until 2 years beyond the end of this study, unless you cancel it. Because research is an ongoing process, we cannot give you an exact date when the study will end.
Clinical trial: NCT03391232
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 6. What Are The Possible Risks Or Discomforts From Being In This Research Study?|Blood Collection:|Tumor Biopsy Risks:|Bleeding|Infection|Are There Any Reproductive Risks?|8. What If You Are Injured From Your Participation In This Research Study? Where To Get Help:|Who Will Pay For The Treatment Of Research Related Injuries:|9. What Are The Possible Benefits From Being In This Research Study?

All drugs may cause certain side effects and discomforts. The most common and expected side effects and discomforts expected for the PolyPEPE1018 are skin reactions, including redness, pain, swelling, warming of the skin, itchiness, and rash, at the injection sites and flu-like symptoms, including fever, chills, weakness, dizziness, nausea or vomiting, muscle ache, fatigue, headache, and occasional breathing difficulties. There may also be side effects and discomforts that are not yet known.

When a sample of your blood is drawn for laboratory tests, you may experience some temporary discomfort, bruising, swelling and/or, in rare circumstances, infection at the needle site.

You will sign a separate consent form before the biopsy is done. This will be a standard surgical consent form from the institution where the biopsy procedure takes place. A biopsy is a safe procedure when performed by an experienced doctor. Serious problems are rare. Possible risks can include:

A small amount of bleeding from the biopsy site can be expected. Excessive bleeding may require you to be hospitalized for a blood transfusion or surgery to stop the bleeding.

Rarely, bacteria may enter the abdominal cavity or bloodstream and cause an infection which could require antibiotics. Accidental injury to a nearby organ In rare instances, the needle may stick another internal organ, such as the gallbladder, intestines, kidney, or a lung.

Women: It is not known if the study treatment may affect an unborn child or nursing infant. For this reason, if you are breastfeeding, pregnant, or plan to become pregnant, you may not participate in this study. If you are capable of becoming pregnant, you must use an acceptable method of birth control throughout the entire study (see below). Pregnancy: If you become pregnant during your participation in the study, your participation in the study may be stopped. However, data information about your pregnancy may be collected. You/your partner may be requested to sign a separate informed consent form prior to collection of data about the outcome of the pregnancy and associated outcome for scientific or security reasons. Men: It is not known if the study treatment may affect your sperm or an unborn child. For this reason, you must use an acceptable method of birth control throughout the entire study (see below) and not donate sperm for 3 months from the day of the treatment. If your partner becomes pregnant, she may be requested to sign a separate informed consent form for the collection of data about the pregnancy and the outcome of the pregnancy. Birth Control: Birth control methods considered acceptable for this study include hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, cervical cap, or condom. It is important that you tell the study doctor immediately if you or your partner becomes pregnant during the study. The doctor will talk with you about what you should do.

If you think you have suffered a research-related injury, you should promptly notify the Principal Investigator listed in the Contact Information at the beginning of this form. Mayo Clinic will offer care for research-related injuries, including first aid, emergency treatment and follow-up care as needed.

The Sponsor, Treos Bio ZRT will offer to pay for medical treatment of research-related injuries directly resulting from the proper application of the study drug. The Sponsor may decide not to pay for several reasons. The Sponsor may not pay if the Sponsor concludes the injury happened because you did not follow the study directions or the injury resulted from your actions. The Sponsor may not consider the worsening of an existing health condition to be a research-related injury. In the case of injury resulting from your participation in this study, you do not lose any of your legal rights to seek payment by signing this form. Contact the Principal Investigator, who can help you obtain this reimbursement.

If the study drug is effective, it may control, reduce, or eliminate your cancer. It is possible that you may not personally benefit from your participation in this study. However, by taking part, you will provide new information that may benefit other patients in the future.
Clinical trial: NCT03391232
Section: Procedures
Subsections: 5. What Will Happen To You While You Are In This Research Study?

At your first visit (Visit 1), the following procedures will be performed to determine if you are suitable to participate in the study:
If you agree to participate in the study, you will be required to sign this informed consent form before any study activities take place.  
Your doctor/staff will discuss all of the requirements for the study and any conditions that will prevent you from being eligible to participate in the trial Your medical history will be reviewed Your prior cancer treatments will be reviewed Your medication history will be reviewed Your doctor will perform a complete physical examination and vital signs (heart rate, oral temperature, breathing rate, sitting blood pressure, height and weight) will be taken Your doctor will assess your ability to perform daily activities A biopsy (a small sample of your tumor tissue) of your tumor will be taken to look for the presence of specific cells called tumor infiltrating lymphocytes or TILs. A biopsy is obtained by taking a small piece of your tumor tissue using a large needle (core biopsy).Alternatively, a small section of your tumor may be removed by cutting it out surgically (excisional biopsy) or with a special round shaped knife (punch biopsy). Your study doctor will explain the details of the procedure depending on how the biopsy will be obtained. This research may help scientists better understand how these TILs affect the treatment of this type of cancer in the future.  
A computed tomography (CT) scan will be performed to assess the extent of your disease and to see if you can participate in this study  
Your doctor/staff will collect about 1-2 tablespoons of blood for laboratory tests to check your overall health and organ functions (such as liver, heart, kidneys, pancreas)
Your doctor/staff will collect about 1 tablespoon of blood for laboratory tests to check tumor biomarkers that are found in the blood and may be related to your reaction to the study drug Your doctor/staff will collect at least 2 tablespoons of your blood to study how your body's immune system responds to certain ingredients of the vaccine. Treos Bio ZRT may store any of this remaining blood sample for up to 2 years after the study completion for additional scientific exploration of how your body's immune system responds to certain ingredients of the vaccine.  
Your doctor/staff will collect at least 2 tablespoons of your urine for laboratory tests to check the health of your urinary tract and kidneys If you are a female and able to get pregnant, you will have a urine pregnancy test. Your doctor/staff will tell you the result of this test The Principal Investigator will review the results of these tests and procedures. If you aren't eligible, the Principal Investigator will tell you why. If you enter the study, additional procedures will also be performed according to the following schedule:
Clinical trial: NCT03391232
Section: Purpose of Research
Subsections: 1. Why Are You Being Asked To Take Part In This Research Study?|2. Why Is This Research Study Being Done?

You are being asked to participate in this research study because you have metastatic colorectal cancer.  
It is expected that approximately 15 subjects will be enrolled in this study, with10 participants being enrolled at Mayo Clinic.

The purpose of this study is to determine if an experimental drug, PolyPEPI1018 vaccine, is safe in the treatment of this disease, in addition to the standard treatment. PolyPEPI1018 has not been previously used in humans. PolyPEPI1018 is a peptide vaccine. The 6 peptides in PolyPEPI1018 contain 12 novel and distinct selected epitopes which are derived from 7 conserved cancer testis antigens (CTAs) that act in combination to activate T cells against CRC antigens in a high proportion of patients. A peptide vaccine is any peptide which serves to immunize an organism against a pathogen. Peptide vaccine is often synthetic and mimics naturally occurring proteins from pathogens.
Clinical trial: NCT03391232
Section: Voluntary Participation
Subsections: Enrollment And Permission Signatures

Your signature documents your permission to take part in this research.  
| /            | /    | :    | AM/PM   |
|--------------|------|------|---------|
| Printed Name | Date | Time |         |  
_______________________________ Signature  
Person Obtaining Consent I have explained the research study to the participant.  
I have answered all questions about this research study to the best of my ability.  
| /            | /    | :    | AM/PM   |
|--------------|------|------|---------|
| Printed Name | Date | Time |         |  
| _______________________________ Signature   |
|---------------------------------------------|
Clinical trial: NCT03391232
Section: Withdrawal from Study
Subsections: 7. Are There Reasons You Might Leave This Research Study Early?

Your participation in this study is voluntary. You do not have to take part, and you may discontinue your involvement at any time without penalty or loss of benefits to which you are otherwise entitled. If you decide to leave the study before the last study visit, tell the study doctor and follow instructions. It may be helpful if you could explain your reasons. You may receive standard treatment and no prejudice will be shown towards you for medical care or participation in future research.  
In addition, your study doctor or the sponsor may withdraw you from the study for your own safety, even if you wish to continue to participate, for example:
If you need additional medication If you experience a study-related injury or unacceptable vaccine site reaction If you do not follow the study rules If you become pregnant If you develop a condition that the study does not allow If at the request of your primary care provider, she/he thinks the study is no longer in your best interest If the study has ended If at the request of the health authority, institutional review board/independent ethics committee, investigator, or pharmaceutical supporter
If your participation in the study is stopped early, you may be asked to complete end-of-study procedures (such as a final physical examination and laboratory tests) for your own safety. Your study doctor will inform you in a timely manner of any new information learned during the study that may affect your willingness to continue your participation.