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 who have been diagnosed with melanoma (skin, acral, mucosal, or from an unknown primary site) at a specific stage of disease, as classified by a standard cancer staging system.
• People who have not previously received any systemic (whole-body) treatment for melanoma (required for Parts 1 and 2 Cohort A).
• People whose melanoma has spread to nearby lymph nodes or other nearby areas and has stopped responding to adjuvant (post-surgery) treatment with anti-PD1 therapy or BRAF-MEK inhibitor drugs (required for Part 2 Cohort B only) — excluding those who previously received certain combination immunotherapy regimens (anti-PD1 plus anti-LAG3, or anti-PD1 plus anti-CTLA4).
• People whose cancer is considered suitable for surgery by the treating surgical specialist.
• People whose melanoma falls into one of several specific patterns: primary melanoma with lymph node spread, returned melanoma in lymph node areas, melanoma involving multiple lymph node groups, single lymph node spread from an unknown primary, melanoma with in-transit or satellite spread that can be surgically removed, or distant spread to skin, soft tissue, or lymph nodes that may be surgically removable.
• People with a general health status rated as fully active or able to carry out light activity (ECOG score of 0 or 1).
• People with adequate organ function based on blood tests taken within 28 days of starting the trial.
• People who can provide a tumour tissue sample (from a biopsy taken within the past 90 days), or who are able to have a fresh biopsy if needed.
• People who have had standard full-body imaging scans as part of their care.
• Women who could become pregnant must have a negative pregnancy test within 72 hours before the first dose.
• Women who could become pregnant must agree to use highly effective contraception from the screening visit until 5 months after the last dose of study treatment.
• Male participants with a female partner who could become pregnant must agree to use highly effective contraception from screening until 5 months after the last dose; if their partner is already pregnant, a condom must be used.
• People who are willing and able to follow all the requirements of the study.

Who may not be able to join:

• People who are currently pregnant or breastfeeding.
• People who have received another experimental drug or other systemic melanoma treatment within the past 4 weeks, or radiotherapy within the past 2 weeks, or who have not yet recovered from side effects of previous treatments.
• People who have had major surgery within the past 4 weeks or who have not fully recovered from surgery.
• People whose melanoma is of the ocular (eye) or uveal type.
• People who have had a bowel obstruction or near-obstruction in the past 3 months.
• People with significant active heart or blood vessel disease, including stroke or heart attack within the past 6 months, unstable chest pain, heart failure, or serious uncontrolled heart rhythm problems requiring medication.
• People with current or past cancer spread to the brain or the lining around the brain.
• People currently being treated for another cancer, or who had another active cancer within the past 2 years (some exceptions may apply for certain early-stage or low-risk cancers — confirm with trial site).
• People who have received certain types of treatments (such as chemotherapy, targeted therapy, or antibody-based treatments) within specific timeframes before starting the trial (confirm exact timeframes with trial site).
• People who received a COVID-19 vaccine or booster fewer than 7 days before their first dose.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People with current or past lung inflammation (interstitial lung disease or pneumonitis) that required high-dose steroid treatment.
• People who have had an organ transplant from another person.
• People with psychiatric conditions or substance use issues that would make it difficult to participate in the study.
• People who need ongoing treatment with corticosteroids above a certain dose (more than 10 mg of prednisone daily) within 14 days, or other immune-suppressing medications within 30 days, before starting the trial.
• People with an active autoimmune disease, or a history of autoimmune disease that required systemic treatment within the past 2 years.
• People with any other condition, infection, or health issue that the investigator believes would make participation unsafe or unsuitable.
• Women who could become pregnant and are not willing to use effective contraception from screening until 5 months after the last dose.
• People who had a COVID-19 infection within 10 days (for mild or no symptoms) or 20 days (for severe illness) before starting the trial.
• People with uncontrolled HIV infection (those on stable effective HIV treatment with undetectable virus and normal immune cell counts for at least 6 months may still be considered — confirm with trial site).
• People with active or uncontrolled hepatitis B virus infection (those on treatment with undetectable virus levels for at least 6 months may still be considered — confirm with trial site).
• People with known active hepatitis C virus infection confirmed by testing (those who have completed treatment and had no detectable virus for at least 6 months may still be considered — confirm with trial site).
• People with known co-infection with hepatitis B and hepatitis C, or hepatitis B and hepatitis D.
• People who rely on intravenous (drip) nutrition as their only source of nutrition.
• People with certain elevated heart enzyme (troponin) levels in blood tests, depending on how high the levels are and whether they return to normal on repeat testing (confirm with trial site).
• People whose heart pumping function (left ventricular ejection fraction) has been measured below 50% within the past 6 months.
• People with a current or past diagnosis of heart muscle inflammation (myocarditis), regardless of the cause.
• People with a known allergy or hypersensitivity to any components of the study treatment.

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