Phase 1 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 who have been confirmed by biopsy to have melanoma that cannot be surgically removed or has spread to other parts of the body (stage IIIc or IV).
• People whose melanoma has continued to grow or spread after receiving standard immunotherapy treatments (anti-PD-1 therapy, either alone or combined with anti-CTLA-4 therapy).
• People aged 18 to 75 years at the time of signing the consent form.
• People who are in good general health and able to carry out normal daily activities with little or no limitation (as measured by a standard medical scoring system).
• People who are well enough to undergo a surgical procedure to remove a tumour sample, and who have at least one tumour larger than 1 cm³ available for removal to produce the treatment cells — unless suitable cells were already collected during an earlier procedure before joining the trial.
• People who have at least one tumour that can be measured using standard imaging methods (not counting the tumour removed to make the treatment cells).
• People whose heart is pumping with at least 50% efficiency, confirmed by a heart scan.
• People whose blood counts, kidney function, liver function, and blood clotting results fall within the ranges required by the trial.
• People who have read and signed the consent form after receiving information about the study.
• People who are willing and able to attend required check-up visits and to manage potential side effects.
• People for whom the trial treatment would be the next therapy after tumour removal (a short bridging therapy may be allowed in some cases if considered necessary by the treating doctor, with a required washout period before the trial treatment begins).
• Women who could become pregnant must have a negative pregnancy test and agree to use an approved method of contraception starting from the first dose of chemotherapy for at least 12 months, and must agree not to donate, store, or bank eggs during that period.
• Men must either be surgically sterile or agree to use a double-barrier contraception method or abstain from sexual activity with someone who could become pregnant, starting from the first dose of chemotherapy for at least 6 months, and must agree not to donate, store, or bank sperm during that period.

Who may not be able to join:

• People who have received certain recent treatments — including chemotherapy, targeted therapies, immune therapies, investigational treatments, corticosteroids above a low dose, prior T-cell or gene therapy, or certain types of radiotherapy — within specific timeframes before tumour removal or the chemotherapy phase of the trial (the exact timeframes vary by treatment type — confirm with trial site).
• People with a history of another cancer, unless they have been free of that cancer for at least 2 years after treatment (some exceptions apply for certain low-risk skin cancers and certain breast conditions being managed with hormone therapy).
• People with melanoma that originated in the eye, mucous membranes, or other non-skin sites (melanoma of unknown primary origin may still be eligible — confirm with trial site).
• People who still have significant side effects from previous cancer treatments that have not recovered to a mild or baseline level (some stable or permanent mild side effects may be acceptable — confirm with trial site).
• People with more than 2 brain tumours, or any brain tumour that is causing symptoms, is larger than 1 cm, or shows significant swelling around it — unless successfully treated with no sign of progression for at least 2 months.
• People with certain heart or lung conditions that would make receiving high-dose interleukin-2 unsafe, including a history of heart bypass procedures, documented low heart pumping efficiency with serious heart rhythm problems, or significantly reduced lung function (particularly in people with a long history of heavy smoking, large lung tumours, or breathing difficulties).
• People with a known allergy to any of the active substances or ingredients used in the trial treatments.
• People with serious ongoing medical conditions such as severe asthma or chronic lung disease, significant heart disease, or poorly controlled insulin-dependent diabetes.
• People with kidney function below the level required by the trial (though in some cases a reduced chemotherapy dose may be considered — confirm with trial site).
• People with active or ongoing infections such as HIV, hepatitis, or syphilis.
• People with severe allergies or a history of a severe allergic reaction (anaphylaxis).
• People with active autoimmune or immune-related diseases that have not resolved (some stable, well-controlled immune conditions may be acceptable — confirm with trial site).
• People who are pregnant or breastfeeding.
• People the trial investigator considers unlikely to be able to follow the trial requirements fully.

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