Phase 2 Melanoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with melanoma that has spread to other parts of your body, confirmed by a tissue sample (biopsy).
• You have at least two measurable tumors that can be tracked using standard imaging measurements.
• One of your tumors (the main one being treated) measures between 1 cm and 7 cm and is suitable for a specific type of focused radiation treatment, as decided by your radiation doctor.
• You are able to lie flat and stay still during radiation treatment sessions.
• You are over 18 years old and able to sign a consent form agreeing to take part.
• You are generally in good physical health and able to carry out daily activities with little or no limitation (confirm with trial site for exact fitness level required).
• Any side effects from previous cancer treatments have mostly cleared up before joining the trial.
• Your blood, kidney, and liver test results are within acceptable ranges (specific lab values will be checked within 21 days of signing consent).
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 72 hours before starting treatment.
• If you are a woman who could become pregnant, you must agree to use two reliable forms of contraception, or abstain from heterosexual sex, starting two weeks before treatment and for 120 days after the last dose.
• If you are a man who has not been surgically sterilised, you must agree to use a reliable form of contraception from the first dose until 120 days after the last dose.

Who may not be able to join:

• You have cancer that has spread to your brain or the lining of your brain and needs urgent treatment there.
• You are currently taking part in another interventional clinical trial (a study testing a treatment).
• You have previously been treated with certain immune checkpoint drugs, including nivolumab, ipilimumab, or similar therapies that target specific immune pathways — though some exceptions may apply (confirm with trial site).
• You are currently receiving any other cancer treatment, such as chemotherapy, immunotherapy, or biological therapy.
• You have received another experimental treatment within the past 4 weeks.
• You have had chemotherapy or other anti-cancer therapy within the past 2 weeks, or have not recovered from its side effects.
• You have a known allergy to nivolumab, ipilimumab, or similar types of drugs (monoclonal antibodies).
• You have had a major surgical procedure within the past 28 days, or are still recovering from surgery.
• You have used immune-suppressing medications in the 14 days before starting the trial, with some exceptions such as low-dose steroids or inhaled/topical steroids (confirm with trial site).
• You have or have had an active autoimmune disease (such as inflammatory bowel disease or certain thyroid conditions) within the past year — though some milder conditions may be exceptions (confirm with trial site).
• You have a history of a condition that severely weakens the immune system, or tuberculosis.
• You have a confirmed positive test for HIV, active Hepatitis B, or active Hepatitis C.
• You have received a live vaccine within the past 28 days.
• Your doctor determines that the planned radiation treatment is not safe for you (for example, due to certain pre-existing conditions).
• You have had radiation treatment to the same area before that would prevent the planned radiation, or any radiotherapy within the past 28 days.
• You are pregnant, breastfeeding, or planning to become pregnant during the study.
• You have another serious uncontrolled illness, such as an active infection, heart problems, uncontrolled high blood pressure, lung disease, or a mental health condition that could affect your ability to take part safely.
• You currently have another active invasive cancer (some past cancers that are in remission may be acceptable — confirm with trial site).
• Your doctor feels there is any other reason that taking part would not be safe or appropriate for you.

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