Clinical trial: NCT03644550
Section: Alternatives
Subsections: What Other Choices Do I Have If I Do Not Continue Pembrolizumab?

Instead of continuing pembrolizumab on this study, you have these options:
- Getting treatment or care for your cancer without being in a study  
- Taking part in another study - Getting 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. Instead, it tries to improve how you feel. Comfort care tries to keep you as active and comfortable as possible.
Please talk to your doctor about these and other options.
Clinical trial: NCT03644550
Section: Confidentiality
Subsections: Confidentiality Protections Provided In This Study Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality|Privacy Act

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
- The National Cancer Institute and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people.  
- National Institutes of Health Intramural Institutional Review Board - Qualified representatives from Merck, the pharmaceutical company who produces pembrolizumab.
When results of an NIH research study are reported in medical journals or at scientific meetings, the people who take part are not named and identified. In most cases, the NIH will not release any information about your research involvement without your written permission. However, if you sign a release of information form, for example, for an insurance company, the NIH will give the insurance company information from your medical record. This information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance. If we share your specimens or data with other researchers, in most circumstances we will remove your identifiers before sharing your specimens or data. You should be aware that there is a slight possibility that someone could figure out the information is about you. Further, the information collected for this study is protected by NIH under a Certificate of Confidentiality and the Privacy Act.

To help us protect your privacy, the NIH Intramural Program has received a Certificate of Confidentiality (Certificate). With this certificate, researchers may not release or use data or information about you except in certain circumstances. NIH researchers must not share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if requested by a court. The Certificate does not protect your information when it:  
1. is disclosed to people connected with the research, for example, information may be used for auditing or program evaluation internally by the NIH; or 2. is required to be disclosed by Federal, State, or local laws, for example, when information must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA);
3. is for other research; 4. is disclosed with your consent.  
The Certificate does not prevent you from voluntarily releasing information about yourself or your involvement in this research. The Certificate will not be used to prevent disclosure to state or local authorities of harm to self or others including, for example, child abuse and neglect, and by signing below you consent to those disclosures. Other permissions for release may be made by signing NIH forms, such as the Notice and Acknowledgement of Information Practices consent.

The Federal Privacy Act generally protects the confidentiality of your NIH medical records we collect under the authority of the Public Health Service Act. In some cases, the Privacy Act protections differ from the Certificate of Confidentiality. For example, sometimes the Privacy Act allows release of information from your medical record without your permission, for example, if it is requested by Congress. Information may also be released for certain research purposes with due consideration and protection, to those engaged by the agency for research purposes, to certain federal and state agencies, for HIV partner notification, for infectious disease or abuse or neglect reporting, to tumor registries, for quality assessment and medical audits, or when the NIH is involved in a lawsuit. However, NIH will only release information from your medical record if it is permitted by both the Certificate of Confidentiality and the Privacy Act.
Clinical trial: NCT03644550
Section: Participant's Rights
Subsections: Who Do You Contact About This Study?

Raffit Hassan, M.D. by phone at 240-760-6232 or email raffit.hassan@nih.gov This consent form describes a research study and is designed to help you decide if you would like to be a part of the research study. You are being asked to take part in a research study at the National Institutes of Health (NIH). Members of the study team will talk with you about the information described in this document. Some people have personal, religious, or ethical beliefs that may limit the kinds of medical or research treatments they would want to receive (such as blood transfusions). Take the time needed to ask any questions and discuss this study with NIH staff, and with your family, friends, and personal health care providers. Taking part in research at the NIH is your choice. If the individual being asked to participate in this research study is not able to give consent to be in this study, you are being asked to give permission for this person as their decision-maker. The term "you" refers to you as the decision-maker and/or the individual being asked to participate in this research, throughout the remainder of this document.
Clinical trial: NCT03644550
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Or Discomforts Of Participation|Potential Benefits Of Participation|Will Taking Part In This Research Study Cost You Anything?|Policy Regarding Research-Related Injuries

In addition to the risks described in the standard consent, continuing treatment as this point might lead you to miss out on alternative approaches as described below.

The potential benefits are similar to what is described in the standard consent; however, as your tumor has grown, it is more likely at this point than it was before that pembrolizumab may not have worked against your tumors.

NIH does not bill health insurance companies or participants for any research or related clinical care that you receive at the NIH Clinical Center.  
- If some tests and procedures performed outside the NIH Clinical Center, you may have to pay for these costs if they are not covered by your insurance company.  
- Medicines that are not part of the study treatment will not be provided or paid for by the NIH Clinical Center.  
- Once you have completed taking part in the study, medical care will no longer be provided by the NIH Clinical Center.

The NIH Clinical Center will provide short-term medical care for any injury resulting from your participation in research here. In general, no long-term medical care or financial compensation for research-related injuries will be provided by the NIH, the NIH Clinical Center, or the Federal Government. However, you have the right to pursue legal remedy if you believe that your injury justifies such action.
Clinical trial: NCT03644550
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Description Of Research Study

After you began treatment with pembrolizumab on this study, it appears as if your tumors might have grown according to our scans. However, studies have shown that therapies such as pembrolizumab that target the immune system sometimes initially cause tumors to grow and then to later shrink. The initial growth is referred to as a tumor flare. Because of this feature of pembrolizumab, we cannot be certain after the first assessment that the study therapy is not working. Furthermore, your clinical condition has not gotten worse.

If you choose to remain on study therapy, you will continue to receive pembrolizumab as described in the standard study consent and continue to have the same assessments (clinical and research). You will be required to continue on birth control as described in the standard consent
Clinical trial: NCT03644550
Section: Voluntary Participation
Subsections: It Is Your Choice To Take Part In The Study|Consent Document

You may choose not to take part in this study for any reason. If you join this study, you may change your mind and stop participating in the study at any time and for any reason. In either case, you will not lose any benefits to which you are otherwise entitled. However, to be seen at the NIH, you must be taking part in a study or are being considered for a study. If you do choose to leave the study, please inform your study team to ensure a safe withdrawal from the research.

Please keep a copy of this document in case you want to read it again.  
Adult Research Participant: I have read the explanation about this study and have been given the opportunity to discuss it and to ask questions. I consent to participate in this study. Signature of Research Participant Print Name of Research Participant Date Legally Authorized Representative (LAR) for an Adult Unable to Consent: I have read the explanation about this study and have been given the opportunity to discuss it and to ask questions. I am legally authorized to make research decisions on behalf of the adult participant unable to consent and have the authority to provide consent to this study. As applicable, the information in the above consent was described to the adult participant unable to consent who agrees to participate in the study.  
Signature of LAR Print Name of LAR Date  
Investigator: Signature of Investigator Print Name of Investigator Date Witness to the oral short-form consent process only: Witness: Signature of Witness* Print Name of Witness Date