NCT03783078

Who might be able to join this trial:

• You are male or female and at least 12 years old at the time of signing the consent form.
• You have been diagnosed with Merkel cell carcinoma (a type of skin cancer) that has come back in the same area after surgery and/or radiation treatment, or has spread to other parts of the body (Stage IV), confirmed by a tissue biopsy.
• You have not previously received treatment for advanced or spread disease, with some exceptions: treatment injected directly into a tumor is allowed; chemotherapy given before or after surgery is allowed if it finished at least 3 months before starting the trial; however, certain immune therapy drugs (anti-PD-1/L1 or anti-CTLA-4) given before or after surgery are not allowed.
• You have at least one tumor that can be measured by a CT or MRI scan.
• Any side effects from your most recent cancer treatment have mostly gone away (down to a mild level or better), except for hair loss.
• You are not pregnant and not breastfeeding, and if you could become pregnant, you are using a highly effective form of contraception or are not sexually active.
• If you could become pregnant, you have had a negative pregnancy test within 72 hours before starting the trial treatment.
• You are generally well enough to carry out normal daily activities, with only minor limitations (confirm with trial site for exact fitness level required).
• Your liver, kidneys, and other organs are working well enough as shown by blood tests.
• You are using contraception consistent with local guidelines if required (for both men and women).

Who may not be able to join:

• You have another cancer that is currently growing or has needed active treatment within the last 2 years (some exceptions may apply — confirm with trial site).
• You have cancer that has spread to your brain or the lining around your brain and it is currently active (some exceptions may apply — confirm with trial site).
• You have a condition that weakens your immune system, or you are taking steroid medication at a certain dose or other immune-suppressing drugs within 7 days before starting the trial.
• You have had a severe allergic reaction to pembrolizumab (the study drug) or any of its ingredients.
• You have an autoimmune disease (where your immune system attacks your own body) that has needed treatment in the last 2 years.
• You have a history of, or currently have, serious lung inflammation that required steroid treatment.
• You currently have an active infection that requires treatment through a drip or tablets.
• You have a known history of HIV infection.
• You have a known history of active Hepatitis B or Hepatitis C infection.
• You have a known history of active tuberculosis (TB).
• You have had a significant heart problem within the last 6 months, such as heart failure, a heart attack, a stroke, or a serious irregular heartbeat.
• You have a medical condition, ongoing treatment, or abnormal test result that the doctor feels could interfere with the study or would not be in your best interest.
• You have a known mental health condition or substance use problem that might make it difficult to take part fully in the study.
• You have not yet had standard surgery or radiation treatment for your cancer in the local area — unless your cancer is already at a stage where it cannot be operated on or has spread.
• You have previously been treated with immunotherapy drugs that target PD-1, PD-L1, PD-L2, or similar immune checkpoint pathways.
• You have received any systemic (whole-body) cancer treatment, including experimental treatments, within the last 12 weeks.
• You have received radiation therapy within the last 2 weeks.
• You have received a live vaccine within the last 30 days before starting the trial.
• You are currently taking part in, or have recently taken part in, another clinical trial involving an experimental drug or device within the last 4 weeks.
• You have previously received an organ or tissue transplant from another person.

Important: Always verify eligibility with the trial site directly before applying.