Phase II Trial of New Immunotherapy Combinations Before Surgery for Advanced Resectable Cutaneous and Mucosal Melanoma

What this Trial Is About

Researchers are evaluating new combinations of immunotherapy for patients with resectable stage 3 cutaneous melanoma and any stage of mucosal melanoma. The study focuses on patients who can have surgery to remove all tumor deposits. The goal is to improve outcomes for patients who typically respond poorly to standard immunotherapy by testing neoadjuvant immunotherapy given before surgery to reduce recurrence. The trial tests six different immunotherapy combinations using the drugs nivolumab, relatlimab, ipilimumab, and pembrolizumab. These are given as two doses before surgery to stimulate the immune system to better attack melanoma cells. After surgery, patients may receive standard immunotherapy if the neoadjuvant treatment does not sufficiently reduce cancer cells. The study includes four phases neoadjuvant treatment, surgery, possible adjuvant therapy, and long-term follow-up for up to 10 years. Participants will undergo assessments including biomarker testing, imaging, and pathology to evaluate tumor response at six weeks. Researchers will monitor survival, recurrence, side effects, and quality of life over 10 years. The study will also explore biomarkers in blood, tumor tissue, and stool to understand treatment response. A total of 493 patients will participate in this phase II trial conducted in Australia.

Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation)