NCT04261855

Who might be able to join this trial:

• You are 18 years of age or older and have agreed in writing to take part in the study.
• You have been diagnosed with Merkel cell carcinoma (MCC) that has spread to other parts of the body, confirmed by a tissue biopsy.
• You are reasonably well and able to carry out daily activities, with only mild limitations at most (confirm with trial site).
• You are willing and able to follow all study requirements for the full length of the trial.
• Your cancer can be measured on a CT or MRI scan using standard measurement guidelines.
• You have not yet had any systemic (whole-body) treatment for your advanced or spreading MCC — note that previous chemotherapy given earlier to treat localised disease, or previous radiotherapy to the original tumour site, is allowed.
• At least 2 weeks have passed since you finished any previous treatment, including surgery or radiotherapy.
• Your recent blood test results (taken within 14 days before joining) meet the levels required by the study (confirm with trial site for specific values).
• If you are a woman who could become pregnant, you must use an appropriate form of contraception during the study.
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment, and repeat pregnancy tests every 4 weeks during the study.
• If you are a man who is sexually active with a woman who could become pregnant, you must use contraception with a very high reliability rate (less than 1% chance of failure per year).
• You must agree to provide a stored tumour tissue sample for the study.

Who may not be able to join:

• You have ever had cancer spread to your brain or the lining around your brain or spinal cord.
• You have previously been treated with certain immune system drugs called checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies), or similar drugs that work on the immune system in related ways.
• You have previously been treated with a specific radioactive therapy called 177Lu-DOTATATE.
• You have been diagnosed with another cancer within the past 2 years, unless it was a type that is considered easily cured and appears to have been fully treated (such as certain skin cancers or very early-stage cancers in limited areas).
• Your doctors estimate you have 6 months or less to live.
• You have an active autoimmune disease (where your immune system attacks your own body) that could become seriously worse with immune-stimulating treatment — though some milder or stable autoimmune conditions may still be allowed (confirm with trial site).
• You are currently taking medication that suppresses your immune system, with some exceptions (confirm with trial site for details).
• You have previously had an organ transplant or a bone marrow/stem cell transplant from a donor.
• You have a known history of HIV infection or AIDS.
• You have tested positive for active Hepatitis B or Hepatitis C infection.
• You are currently pregnant or breastfeeding.
• You have a serious uncontrolled illness, such as an active infection, unstable heart condition, or a mental health or personal situation that would make it difficult to follow the study requirements.
• You are currently taking high-dose steroid tablets (above the equivalent of 10mg of prednisone per day) or other immune-suppressing medications, and have been within the 14 days before starting the study drug.
• You still have significant side effects from a previous cancer treatment that have not resolved, with some minor exceptions (confirm with trial site).
• You have had a severe allergic reaction in the past to the study drug or similar types of drugs (called monoclonal antibodies).
• You have symptoms caused by pressure on your spinal cord that has not been properly treated and stabilised.
• You have received a live vaccine (for example, for flu or chickenpox) within the 30 days before joining the trial.

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