Real-World Study of Tunlametinib to Treat Advanced Melanoma with NRAS Mutation After Anti-PD-1PD-L1 Therapy Failure

What this Trial Is About

Researchers are evaluating the safety and effectiveness of tunlametinib in patients with NRAS-mutant advanced melanoma who have not responded to previous anti-PD-1 or PD-L1 treatments. This prospective, open-label, multicenter real-world study focuses on understanding how this drug works in a real clinical setting for this specific patient group. Participants will receive tunlametinib orally at a dose of 12 mg twice daily in continuous 4-week cycles. Dose adjustments are allowed for managing side effects, with stepwise reductions from 12 mg to 9 mg and then 6 mg twice daily if needed. Imaging assessments will be done every 8 weeks to monitor the disease, and treatment will continue until disease progression, intolerable side effects, consent withdrawal, or other reasons decided by the investigator. After treatment ends, participants will enter a follow-up period including safety checks and survival monitoring. During the study, participants will be monitored regularly through imaging scans, vital signs, lab tests, and assessments of any side effects or additional treatments. Safety follow-up visits will occur 30 days after the last dose, and survival follow-up will continue every 3 months by phone or other means until death or study termination. The main outcome measured will be the objective response rate over 3 years, with participation lasting until treatment discontinuation and through the follow-up periods.

RWS of Tunlametinib in NRAS-Mutant Advanced Melanoma