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 aged 18 or older at the time of screening (or the legal age of consent in their country).
• People who are willing and able to provide written consent before any study procedures begin.
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (this is measured using a standard medical scale called ECOG, scored 0 or 1 — confirm with trial site).
• People with a life expectancy of at least 12 weeks.
• People who have been diagnosed with skin (cutaneous) or mucosal melanoma, confirmed through laboratory tissue testing.
• People with high-risk melanoma at a stage where adjuvant (post-surgery) immunotherapy has been shown to reduce the chance of the cancer returning — this includes stages 2B, 2C, 3A, 3B, 3C, 3D, or stage 4 where the cancer has been fully removed by surgery.
• People who can provide stored tumour tissue samples (a specific type of preserved tissue sample) for research testing.
• People who are planned to have surgery followed by immunotherapy after surgery, with or without radiation, as their main treatment approach.
• People who have no detectable cancer visible on imaging scans (such as CT, MRI, or PET scans).
• Women who could become pregnant and are sexually active with a male partner who has not had a vasectomy must use at least one highly effective form of contraception from the start of the study until 180 days after the last dose of study treatment (periodic abstinence, the rhythm method, and withdrawal are not accepted).
• Men who have not had a vasectomy and are sexually active with a female partner who could become pregnant must use a condom with spermicide from the start of the study until 180 days after the last dose, and must not donate sperm during this period.

Who may not be able to join:

• People diagnosed with uveal melanoma (a type of melanoma that starts in the eye).
• People who have previously received any systemic (whole-body) cancer treatment for melanoma, or who are currently receiving any cancer treatment (hormone therapy for non-cancer reasons, such as menopause, is allowed).
• People whose cancer has spread to other parts of the body, as found through surgery or imaging scans.
• People who have had an organ transplant from another person.
• People with a history of serious allergic reactions to medications that are chemically or biologically similar to the study drugs (anti-PD-1 or anti-LAG-3 therapies).
• People with a history of a primary immune system deficiency disorder.
• People with active autoimmune or inflammatory conditions such as inflammatory bowel disease, lupus, sarcoidosis, Wegener's disease, rheumatoid arthritis, or similar conditions — though some exceptions may apply, including people with vitiligo, hair loss (alopecia), stable underactive thyroid on hormone replacement, certain mild chronic skin conditions not needing systemic treatment, or coeliac disease managed by diet alone (confirm with trial site).
• People with active infections including tuberculosis, active hepatitis B, or active hepatitis C — though people with certain past or resolved hepatitis B or C infections may still be eligible (confirm with trial site). People with well-controlled HIV are allowed.
• People with serious uncontrolled illnesses, including active infections, heart failure, uncontrolled high blood pressure, recent heart attack (within the last 4 months), serious lung or gut conditions, or mental health or social situations that would make it difficult to follow the study requirements.
• People with a history of another cancer, with some exceptions — including cancers treated with curative intent with no known active disease for 3 or more years, certain treated skin cancers, treated non-invasive cancers (carcinoma in situ), or certain low-stage prostate cancers not requiring active treatment (confirm with trial site).
• People with a certain type of heart rhythm abnormality detected on a heart tracing (ECG), specifically a QTcF interval of 500 milliseconds or more (confirm with trial site).
• People who have previously received nivolumab or relatlimab (the study drugs).
• People who have taken immunosuppressive medications within 14 days before the first dose — though some exceptions apply, such as low-dose inhaled, topical, or local steroid treatments, or low-dose systemic steroids (confirm with trial site).
• People who have received a live vaccine within 30 days before starting the study treatment.
• People who have participated in another clinical trial involving an experimental treatment within the past 28 days, or who are currently enrolled in another treatment-based clinical trial.
• People who, in the investigator's judgement, are unlikely to follow the study procedures or requirements.
• Women who are currently pregnant or breastfeeding.
• People who are unable or unwilling to give consent or follow the study procedures.

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