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 who are willing to take part voluntarily and sign a consent form
• Men or women aged between 18 and 70 years (inclusive)
• People whose doctors expect them to live for at least 12 weeks
• People who are fairly active and able to care for themselves, with little or no limitation on daily activities (measured by a standard performance scale called ECOG, scored 0 or 1)
• People with advanced solid tumours — including bile duct or gallbladder cancers, or malignant melanoma (a type of skin cancer) — that cannot be surgically removed or have spread to other parts of the body, confirmed by laboratory testing of tissue or cells
• For Part I of the trial: people whose cancer has stopped responding to standard treatments, or for whom no effective standard treatment exists (people who have previously received certain immunotherapy drugs targeting PD-1, PD-L1, or CTLA-4 may still be considered)
• For Part II of the trial: people who have not yet received any systemic (whole-body) treatment for their cancer — though previous treatments given before or after surgery are allowed, as long as they were completed at least 6 months ago

Who may not be able to join:

• People whose cancer has been identified through biopsy as a specific type called "carcinoma of the jugular abdomen" (confirm with trial site for clarification on this term)
• People with melanoma who are known to have certain specific genetic changes (BRAF V600E or NRAS mutations)
• People with bile duct cancer or gallbladder cancer who are known to have certain specific genetic changes (BRAF V600E mutation, NTRK gene fusion, RET gene fusion, FGFR2 gene fusion, IDH1 gene mutation, or KRAS mutation)
• People with brain metastases (cancer that has spread to the brain) that are causing symptoms — though people with brain metastases that are not causing symptoms, do not require steroids or anti-seizure medication, and have been stable on scans for at least 4 weeks may still be considered
• People who have had a different cancer (other than bile duct cancer or melanoma) within the past 5 years — with exceptions for certain low-risk or successfully treated cancers such as early-stage cervical, skin, prostate, or uterine cancers
• People with an active autoimmune disease (where the immune system attacks the body), a history of one that may come back, or conditions requiring immune-suppressing drugs such as after an organ transplant — though people with stable Type 1 diabetes on a fixed insulin dose, autoimmune thyroid conditions or adrenal insufficiency managed only with hormone replacement, or mild skin conditions not requiring systemic treatment may still be considered
• People with serious heart conditions, including severe heart failure, unstable chest pain, high blood pressure not controlled by medication, irregular heart rhythms, a heart attack within the past 6 months, or a blood clot in an artery or lung within the past 3 months
• People with serious lung conditions requiring treatment, such as interstitial lung disease, lung scarring, or severe inflammation of the lungs
• People with other serious uncontrolled health conditions, including severely uncontrolled diabetes (very high fasting blood sugar), active infections, or psychiatric conditions (such as epilepsy) that may make it difficult to follow the trial requirements
• People with fluid build-up around the lungs, in the abdomen, or around the heart that cannot be controlled and requires repeated draining — though people who already have a permanent drain in place may still be considered

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