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 mucosal melanoma (a type of skin cancer affecting inner body surfaces) that cannot be surgically removed, located in areas such as the head/neck (like the nose, sinuses, or mouth), digestive tract (like the rectum or esophagus), or urinary/reproductive areas (like the vulva or urethra).
• Your cancer can be measured or detected on imaging scans.
• You have not previously received any systemic (whole-body) cancer treatment, such as chemotherapy or immunotherapy, before joining the main part of the trial; or, for certain parts of the trial, your only prior treatment was nivolumab and axitinib through this same trial.
• Your general health and ability to carry out daily activities meets the study's requirements (rated 0–2 on a standard medical scale, meaning you are fully active to capable of basic self-care).
• You have brain tumours that are either causing no symptoms, or were treated with radiation or surgery and have been stable for at least 2 weeks without needing increased steroid medication.
• Your blood test results meet minimum levels for blood cells, liver function, and kidney function (confirm specific numbers with the trial site).
• You are 18 years of age or older.
• If you are a woman who could become pregnant and are sexually active with a non-sterile male partner, you must agree to use 2 effective forms of contraception during the trial and for 23 weeks after your last dose of the study drug.
• If you are a non-sterile male and sexually active with a partner who could become pregnant, you must agree to use 2 effective forms of contraception from the start of the trial and for 31 weeks after your last dose of the study drug.
• Acceptable contraception methods include barrier methods (e.g., condom plus spermicide), intrauterine devices, or hormonal methods (e.g., pill, implant, patch, or injection).

Who may not be able to join:

• You have an active autoimmune disease (where the immune system attacks the body) or are taking steroid medications above a low daily dose, or other immune-suppressing drugs, within 14 days of starting the study drug.
• You have a history of certain nerve or muscle conditions caused by the immune system, such as Guillain-Barré Syndrome or Myasthenia Gravis.
• You have a history of inflammation of the heart muscle (myocarditis).
• You have a history of, or currently have, non-infectious lung inflammation (pneumonitis).
• You have another active cancer that requires ongoing treatment or makes it harder to track your melanoma's response to treatment.
• You have certain heart conditions, including: a heart attack, unstable chest pain, or heart surgery/procedures within the past 6 months; moderate-to-severe heart failure; or high blood pressure that cannot be controlled with medication.
• You have certain blood-related conditions, including: an inherited bleeding disorder; bleeding from the digestive tract requiring treatment in the past 6 months; coughing up blood within the past 42 days; or blood clots in the lungs or legs that are not stable on blood-thinning medication.
• You have had a severe allergic reaction to an unknown substance or to any of the drugs used in this trial.
• You have a serious active infection, such as active COVID-19, an immune condition following a recent infection, or a serious bacterial infection currently requiring antibiotics.
• You are currently pregnant or breastfeeding.
• You have a genetic or immune condition that makes you unusually sensitive to radiation (confirm with trial site).

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