Phase 3 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 18 years of age or older (or the legal age of adulthood in their country) at the time of signing the consent form.
• People who weigh at least 50 kg at the start of the trial.
• People who have signed a consent form before any trial-related procedures begin.
• People whose general health and ability to carry out daily activities is rated at a good to fully active level (ECOG score of 0 or 1) (confirm with trial site).
• People who are expected to live for at least 3 months.
• People who have been diagnosed with advanced melanoma that cannot be surgically removed, classified as Stage III or Stage IV, and who have not yet received treatment for this stage of the disease. People who received treatment for an earlier stage of melanoma may still be considered if they were free of the disease for at least 1 year after finishing that treatment, provided that treatment did not include medications that are not permitted in this trial.
• People who have at least one area of melanoma that can be measured on a CT or MRI scan.
• People who are able to provide a tumour tissue sample from an unresectable or spread site of disease, collected within 90 days before joining the trial, that tests positive for a protein marker called PD-L1 at certain levels (confirm with trial site).
• People who have had palliative radiotherapy on spread sites of disease, provided it was completed at least 2 weeks before the trial treatment begins.
• People with any BRAF mutation status — mutated, not mutated, or unknown — are considered.
• People whose blood, kidney, liver, thyroid, and clotting function meet the required levels during the screening period (confirm with trial site).
• People who are able and willing to use a highly effective form of contraception during the trial and for at least 5 months after the last dose of the study drug, where applicable.
• People who are not able to have children are also able to be considered.

Who may not be able to join:

• People who have previously received any systemic treatment for advanced, unresectable, or metastatic Stage III or Stage IV melanoma (other than palliative radiotherapy as noted above).
• People who have previously received any form of immunotherapy at any stage of melanoma, or any BRAF-targeted therapy.
• People who have taken part in another clinical trial or received an experimental treatment within 4 weeks, or within 5 half-lives of that treatment, before joining — whichever is the longer period.
• People who have melanoma that has spread to the brain or to the membranes surrounding the brain or spinal cord. A brain scan taken within the past 90 days showing no spread is required.
• People who have melanoma spread throughout the lining of the abdominal cavity.
• People whose melanoma originated in the eye, in mucous membranes, or in certain areas of the hands or feet (acral lentiginous melanoma).
• People who have had another cancer, or currently have another cancer, unless they have been free of that cancer for at least 3 years, or unless it was a fully removed non-melanoma skin cancer or a successfully treated early-stage cancer confined to one area (such as cervical cancer in situ).
• People who have an active autoimmune disease that has required systemic medical treatment within the last 2 years. Hormone replacement therapies and low-dose steroid replacement therapies for certain gland conditions are not considered systemic treatment for this purpose.
• People with an overactive or underactive thyroid, unless their condition is stable and well managed with hormone replacement therapy.
• People who have been diagnosed with an immune system deficiency, or who are taking steroid tablets or any other medication that suppresses the immune system, within 7 days before the first dose of the trial drug. Certain local steroid treatments (inhaled, nasal spray, eye drops, or skin-applied) are permitted.
• People who have had major surgery within 28 days before the first dose of the trial drug.
• People who have received a solid organ, tissue, or bone marrow transplant from another person.
• People who have a history of, or currently have, a lung condition called interstitial lung disease or non-infectious pneumonitis that has required steroid or immunosuppressive treatment.
• People who have had an active infection requiring treatment within 30 days before the first dose of the trial drug.
• People who have received, or are due to receive, a live virus vaccine within 30 days before the first dose of the trial drug. Non-live seasonal flu and COVID-19 vaccines are permitted.
• People with active or untreated inactive tuberculosis (TB).
• People who test positive for HIV, hepatitis B, hepatitis C, or an untreated parasitic infection called Strongyloides, based on specific test results (confirm with trial site).
• People who are currently using illicit drugs recreationally, or who have had a history of substance misuse including alcohol within the past year.
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial or within 5 months after the last dose of the study drug.
• People who are an immediate family member of, or are directly involved staff at, the research site or the company sponsoring the trial.
• People whose overall health or circumstances, in the judgement of the trial doctor, would make participation unsafe or unsuitable, or would make it difficult to interpret the trial results.

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