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 signed and dated a written consent form approved by an ethics committee, before any study-related procedures begin.
• People who are willing and able to attend scheduled visits, follow the treatment plan, have laboratory tests, tumor biopsies, and meet other study requirements.
• People diagnosed with Stage IIIb, IIIc, IIId, or Stage IV melanoma (confirmed by tissue testing) that cannot be surgically removed — including mucosal melanoma and all melanoma types except eye/uveal melanoma.
• People who have not previously received any anticancer treatment for metastatic melanoma (with some exceptions, such as prior surgery, brain radiation after surgery, local radiation to a specific area, or certain past adjuvant treatments including nivolumab, pembrolizumab, dabrafenib, trametinib, interferon, or ipilimumab — confirm details with the trial site).
• People who have had a full physical examination and imaging scans (CT scan of chest, abdomen, and pelvis, plus a brain MRI or CT) completed within 4 weeks before the first study treatment.
• People whose disease can be measured using standard imaging criteria (known as RECIST 1.1).
• People for whom a complete set of baseline scan images is available before treatment begins.

Who may not be able to join:

• People who have brain metastases that have not yet been treated, cancer that has spread to the lining of the brain (carcinomatous meningitis), or current eye/uveal melanoma.
• People who have had a different (non-melanoma) cancer in the past, unless that cancer was completely removed or went into full remission at least 2 years before joining the study and no further treatment for it is needed or expected during the study (exceptions include certain low-risk cancers such as non-melanoma skin cancer, early-stage in situ cancers of the bladder, stomach, colon, or cervix, or breast carcinoma in situ — confirm with the trial site).
• People with an active, known, or suspected autoimmune disease. However, people with type 1 diabetes, an underactive thyroid due to autoimmune thyroiditis that is managed only with hormone replacement, or skin conditions such as vitiligo, psoriasis, or hair loss that do not require systemic (whole-body) treatment may still be considered eligible.
• People who are currently taking corticosteroids at a dose greater than 10 mg of prednisone per day (or an equivalent dose of another steroid), or other medications that suppress the immune system, within 14 days of starting the study drug. Inhaled or topical (applied to the skin) steroids are generally permitted, provided there is no active autoimmune disease.

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