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 have been diagnosed with Stage III or IV skin melanoma (confirmed by tissue testing) that cannot be surgically removed.
• People who have not previously received treatment for melanoma, or who received earlier preventive treatment (before or after surgery) with certain immunotherapy or targeted therapy drugs — but only if the cancer did not return within 12 months of finishing that treatment.
• People who have had their melanoma tested for a specific gene change called BRAF V600, or are willing to have this test during screening — both those with and without this gene change are included.
• People who have at least one measurable area of cancer that can be seen on a CT or MRI scan.
• People who are able to provide a tissue sample from their cancer (preferably from a spread site) suitable for detailed genetic and biomarker analysis.
• People living with HIV, provided the HIV is well controlled on anti-HIV medication.
• People who have hepatitis B, provided they have been on hepatitis B antiviral treatment for at least 4 weeks and the virus is undetectable before joining.
• People with a history of hepatitis C, provided the virus is undetectable at screening.

Who may not be able to join:

• People who have had significant heart failure (classified as a severe or very severe level) in the past 6 months, unless the condition is considered well controlled by the treating doctor.
• People living with HIV who also have a history of Kaposi's sarcoma or a condition called Multicentric Castleman's Disease.
• People whose melanoma started in the eye or in the mucous membranes (such as inside the mouth or nose).
• People who received a blood transfusion or certain blood-stimulating injections within 2 weeks before their screening blood test.
• People who have previously received certain immunotherapy drugs that target immune system checkpoints (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar treatments), except in certain situations (confirm with trial site).
• People who have previously received systemic (whole-body) drug treatment for melanoma, except in certain situations (confirm with trial site).
• People who received radiotherapy within 2 weeks before starting the study treatment, or who are still experiencing side effects from radiation.
• People who received a live vaccine within 30 days before their first dose of the study treatment.
• People who have previously received any personalised or general cancer vaccine treatment.

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