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:

• People who are 18 years of age or older at the time of giving consent
• People who are able to give informed consent themselves, or who have a legally authorised representative who can do so on their behalf
• People who have been diagnosed with advanced or metastatic melanoma (skin or mucosal type, stage III or IV) that has been confirmed by tissue testing, and whose cancer has continued to grow or spread after receiving a type of immunotherapy called PD-1 or PD-L1 treatment — with different requirements depending on which group (Cohort A or B) a person is being considered for (confirm with trial site)
• People whose cancer can be measured on scans according to standard criteria (RECIST v1.1)
• People who are willing to provide stored tissue samples if available; if no stored sample exists, people may still be considered, and a new biopsy will be attempted if it is safe to do so
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health scale (ECOG score of 0 or 1)
• People whose blood test results meet minimum levels for red blood cells, platelets, and liver and kidney function at the time of screening
• People who show no signs of active heart problems such as reduced blood flow to the heart
• People whose kidney function meets a minimum level based on a standard calculation
• People whose side effects from prior immunotherapy have mostly resolved (settled to a mild level or gone away), with an exception for people with stable adrenal gland insufficiency who are on a low-dose steroid replacement and are not experiencing symptoms
• People who are able and willing to use highly effective contraception before, during, and for at least 6 months after treatment — this applies to women who could become pregnant and to sexually active men (specific methods are outlined in the trial criteria; confirm with trial site)

Who may not be able to join:

• People whose melanoma originated in the eye (uveal melanoma)
• People who have melanoma that has spread to the brain or spinal fluid lining and has not yet been treated; people whose brain metastases have already been treated with surgery or a targeted form of radiation may still be considered
• People who have previously received certain immunotherapy drugs, depending on which cohort is being considered — for example, prior anti-LAG-3 or anti-CTLA-4 therapies may be disqualifying in some cases unless given in a specific early-treatment setting and more than three months before the cancer returned (confirm with trial site)
• People who experienced a severe (Grade 3 or higher) nervous system side effect from a previous immunotherapy treatment
• People who have previously had inflammation of the heart muscle (myocarditis) as a result of immunotherapy
• People who previously experienced severe inflammation of the bowel (Grade 3 or higher colitis or enteritis) that required hospitalisation
• People who are currently taking steroid medications at doses higher than a low physiologic replacement level, or other immune-suppressing medications, within 14 days of starting treatment (inhaled or topical steroids are generally permitted if there is no active autoimmune condition)
• People who have received a live vaccine within 30 days before the planned start of treatment
• People who have had a significant infection requiring antibiotic treatment within 2 weeks before the planned start of treatment
• People with an uncontrolled or unstable medical condition or organ problem that, in the treating doctor's opinion, could put the person at risk or affect their ability to follow the study procedures
• People who have another active cancer that requires ongoing systemic treatment or that would make it difficult to assess how the melanoma is responding to treatment
• People with a history of severe allergic reactions to any unknown allergens or to components of the study drugs
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection, or a diagnosed condition affecting the immune system — note that people with well-controlled HIV, hepatitis B, or hepatitis C (meeting specific criteria) may still be considered (confirm with trial site)
• People who are pregnant or breastfeeding
• People who are currently imprisoned or involuntarily detained (with limited exceptions where local laws permit)
• People who are being held involuntarily for treatment of a psychiatric or physical illness

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