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 giving consent
• People who are willing and able to give written consent to take part
• People who have been confirmed by lab testing (from a tissue or cell sample) to have melanoma of the skin or from an unknown starting point, at a stage classified as IIIB, IIIC, or IIID, where surgery to remove the cancer is planned
• People who have at least one affected lymph node that has been confirmed by pathology — either one that can be felt, one that appears enlarged on imaging, or one detected by ultrasound or PET/CT scan
• People who have up to three small nearby skin or under-skin tumour deposits (called satellite or in-transit metastases) that can be fully removed with surgery
• People whose affected lymph nodes are in the groin, armpit, or neck only — on one or both sides — with certain other nearby node locations also permitted if they can be fully removed
• People whose tumour is suitable for a fresh tissue biopsy from an area that has not previously been treated with radiation
• People who are scheduled to receive a pre-surgery (neoadjuvant) immunotherapy treatment that includes at least one type of drug known as a PD-(L)-1 checkpoint inhibitor (for example, nivolumab, pembrolizumab, or cemiplimab), and whose treating doctor has determined they are fit for that treatment based on the relevant approved prescribing information
• People whose planned pre-surgery immunotherapy course will last no longer than 6 weeks (up to three treatment cycles)
• People who are generally active and able to care for themselves, with only mild or no limitations on daily activity (known as ECOG performance status 0 or 1)
• People with an expected life expectancy of more than 5 years

Who may not be able to join:

• People whose melanoma started in the eye (uveal melanoma) or in a mucous membrane (mucosal melanoma)
• People who only have satellite or in-transit skin deposits, with no confirmed lymph node involvement
• People who have affected lymph nodes in areas of the body other than the groin, armpit, or neck — unless they are in certain specific additional locations and can be fully removed
• People who have signs, based on examination or imaging, that the cancer has spread to distant parts of the body
• People who have previously had surgery on the same group of lymph nodes that went further than a sentinel lymph node biopsy
• People who have previously had radiation treatment to the same group of lymph nodes
• People for whom any of the relevant immunotherapy medicines (such as nivolumab, ipilimumab, pembrolizumab, or relatlimab) are medically unsuitable, based on approved prescribing information or the treating doctor's assessment
• People who have previously received any immunotherapy drugs targeting PD-1, CTLA-4, PD-L1, or LAG-3, or any other similar immune-targeting treatments, or any chemotherapy or experimental treatments
• People whose treatment plan includes targeted therapy, non-checkpoint immunotherapy, or direct injection of treatment into a tumour before surgery
• People whose treatment plan includes any experimental immunotherapy as part of another clinical trial before surgery
• People who have had another cancer that has been active within the past 3 years — though certain cancers may be permitted if they were successfully treated (confirm with trial site), including basal cell skin cancer, squamous cell skin cancer, certain in-situ (very early, non-spreading) cancers that received curative treatment, early-stage prostate tissue changes, in-situ melanoma, atypical melanocytic hyperplasia, Stage I melanoma, or other cancers where the person has been cancer-free for 3 years without ongoing treatment
• People with an active autoimmune disease, or who require ongoing high-dose steroid tablets or other immune-suppressing medicines (with some exceptions for replacement hormone therapies, inhaled or nasal steroids at a stable dose, or steroid injections directly into a joint)
• People who have received an organ or tissue transplant from another person
• People with an active hepatitis B or hepatitis C infection (testing is only required if local health authorities require it)
• People with a known history of HIV infection (testing is only required if local health authorities require it)
• People who are pregnant or breastfeeding
• People whose personal or medical circumstances would prevent them from attending all required appointments and procedures as scheduled

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