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 willing and able to provide written consent to take part.
• People who are 18 years of age or older.
• People who are in good general health and able to carry out normal daily activities with little or no limitation (assessed using a standard health performance scale called ECOG/WHO 0-1).
• People whose liver, kidneys, and other organs are functioning well enough to safely receive immunotherapy.
• People who have had surgery to fully remove cutaneous malignant melanoma (a type of skin cancer, including a form called acral melanoma) at an advanced stage (stage IIb, IIc, III, or IV), including cases where the melanoma has spread to nearby skin or lymph nodes.
• People with stage III melanoma where the original tumour site is unknown, or stage IIb-c melanoma where a sentinel node procedure was not performed, may still be considered.
• People who have had a full physical examination within the 28 days before being enrolled in the trial.
• People who have previously received targeted therapy (BRAF + MEK inhibitors) as an adjuvant treatment (treatment after surgery to reduce recurrence risk).
• People who have received a short course of pre-surgery immunotherapy (neoadjuvant treatment), provided they did not have a complete or near-complete response to it, and their cancer did not clearly progress during that treatment.
• People who have not had pre-surgery immunotherapy must have a scan confirming no detectable disease within 28 days before enrolment; for those who did have pre-surgery immunotherapy, a scan within 6 weeks is sufficient.
• People who have been off high-dose steroid medications (more than 10mg per day of prednisone or equivalent) for at least 14 days before starting the trial treatment.
• People with adequate kidney function to safely receive contrast dye used in scans.
• People who have received radiation therapy around the time of their surgery.
• People who experienced a return of melanoma to nearby lymph nodes (a locoregional relapse, classified as stage III or operable stage IV) after their original diagnosis.

Who may not be able to join:

• People assessed by the trial doctor as not well enough to receive systemic (whole-body) treatment after surgery.
• People with a serious or uncontrolled medical condition that the trial doctor considers unsafe for participation.
• People with an active autoimmune disease (a condition where the immune system attacks the body), although people with type 1 diabetes, thyroid conditions managed with hormone replacement only, or certain skin conditions like vitiligo, psoriasis, or alopecia that do not require systemic treatment may still be eligible (confirm with trial site).
• People whose life expectancy is less than 2 years due to another serious illness, such as a significant heart condition or severe liver disease.
• People who are unable or unwilling to provide informed consent to participate.
• People who would not be able to follow the requirements of the trial schedule and procedures.
• People currently taking part in another clinical trial that would interfere with this one.
• People who have had another cancer diagnosis within the past 5 years, with the exception of certain low-risk cancers including in situ breast or cervical cancer, melanoma in situ, non-melanoma skin cancer, and low-risk prostate cancer.
• People who are pregnant or planning to become pregnant.
• People whose melanoma originated in the eye (ocular) or on mucous membranes (mucosal), such as inside the mouth or nasal passages.

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