Phase 2 Melanoma Trial, Recruiting

Written by an AI model from the 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 have one or more tumour lesions from which a tissue sample (biopsy) can be safely taken using standard medical procedures.
• People whose cancer can be measured on scans, following standard measurement guidelines (RECIST v1.1). Lesions that have already been treated with radiation cannot be used as the main lesions being measured.
• People who are also able to participate in a related imaging study called GE-269-001, if places are available in that study.
• People who have given written agreement (informed consent) to take part.
• People aged 18 or older at the time of signing consent.
• People with a life expectancy of at least 12 weeks.
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health scale (ECOG performance status of 0 or 1).
• People whose blood counts and kidney function meet the required levels: haemoglobin of at least 9.0 g/dL, platelet count of at least 100 x 10⁹/L, and kidney function within acceptable ranges (confirm with trial site for exact values).
• People whose liver function test results fall within acceptable ranges, including bilirubin, AST, ALT, and ALP levels — with slightly higher limits allowed if the liver or bones are affected by the cancer. People with a documented condition called Gilbert's syndrome have a different bilirubin requirement (confirm with trial site).
• People who are able to follow the study schedule and requirements.
• Women who could become pregnant, and men whose partners could become pregnant, where the patient and/or partner agrees to use a highly effective form of contraception (less than 1% failure rate per year when used correctly and consistently).
• For the head and neck cancer group specifically: people with certain types of resectable (surgically removable) head and neck squamous cell carcinoma that is not related to HPV (p16-negative), including cancers of the oral cavity, larynx, hypopharynx, oropharynx, or unknown primary — with no spread to distant parts of the body and no previous radiation to the head and neck area (confirm specific tumour stage requirements with trial site).

Who may not be able to join:

• People who have had signs or symptoms of an infection within the 2 weeks before starting the trial treatments.
• People who have previously been treated with immune checkpoint inhibitor drugs (such as anti-PD-1 or anti-PD-L1 medicines) — this applies to certain groups within the trial (cohorts 1, 2, and 4; confirm with trial site).
• People who have had a severe allergic or hypersensitivity reaction to similar types of antibody-based medicines in the past.
• People with any other significant medical condition, abnormal test result, or health finding that would make the trial treatments unsafe or make it difficult to interpret the trial results.
• Women who are pregnant or breastfeeding.
• People who test positive for HIV, active hepatitis B, or hepatitis C. People with a past (not active) hepatitis B infection may still be considered. People who test positive for hepatitis C antibodies may be considered if a follow-up RNA test is negative (confirm with trial site).
• People with an active or ongoing Epstein-Barr virus (EBV) infection at the time of screening. People who have had EBV in the past may still be considered if a specific blood test (EBV PCR) comes back negative (confirm with trial site).
• People with active tuberculosis.
• People who have been treated with certain immune-stimulating medications (such as interferons or interleukin-2) within 6 weeks or five half-lives of the drug (whichever is shorter) before starting the trial.
• People who have been taking immune-suppressing medications (such as prednisone, methotrexate, or similar drugs) within 2 weeks before the trial starts. Some exceptions apply, such as low-dose inhaled steroids or topical steroids — the trial site would assess these on a case-by-case basis.
• People who have cancer that has spread to the brain or the lining of the brain and spinal cord.

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