Clear Me Phase II Study Testing Combination and Single Anti-PD-1LAG3 Therapy to Clear Residual Disease in High-Risk Melanoma After Surgery

What this Trial Is About

Researchers are evaluating whether combining anti-LAG3 and anti-PD-1 drugs is more effective than anti-PD-1 alone in patients with high-risk melanoma who have detectable circulating tumor DNA ctDNA after surgery. This phase II study focuses on patients with stage 2B to 4 melanoma following definitive surgery. The study aims to understand if the combination treatment can better clear molecular residual disease, potentially lowering the risk of cancer recurrence. Participants will be randomly assigned to one of two groups one receiving Opdualag a combination of anti-LAG3 and anti-PD-1 and the other receiving Nivolumab anti-PD-1 alone. Both treatments are given through intravenous infusion every four weeks. The randomization accounts for different melanoma stages to balance groups. About 270 patients will be screened to find at least 54 with detectable ctDNA who will proceed with treatment and follow-up. Throughout the study, participants will have their ctDNA levels monitored to assess clearance at 12 months after starting treatment. Researchers will also track recurrence-free survival at 12 and 36 months and monitor any treatment-related side effects for up to six years. Patients will undergo imaging scans and laboratory tests to ensure no detectable disease at the start and to evaluate their health during treatment. The study lasts several years, allowing thorough observation of long-term outcomes and safety.

Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma