Study of LNS8801 Alone or With Pembrolizumab Compared to Physicians Choice in Adults With Treatment-Resistant Unresectable Melanoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new drug called LNS8801 for treating patients with melanoma that cannot be removed by surgery and has not responded to previous immune checkpoint inhibitor therapy. The study focuses on patients who have a specific genetic makeup two copies of the functional GPER protein-coding sequence and have melanoma that has progressed despite prior treatments. The main goal is to measure the average time during which melanoma does not grow or spread after starting treatment with LNS8801, either alone or combined with pembrolizumab, compared to other treatments chosen by the doctor. Participants will be randomly assigned to one of three groups. The first group will take 125 mg of LNS8801 by mouth daily for up to two years. The second group will take the same dose of LNS8801 daily plus 200 mg of pembrolizumab through an IV infusion every three weeks, also for up to two years. The third group will receive chemotherapy or immunotherapy as decided by their physician. The pembrolizumab dose may be adjusted after six months if appropriate. Patients in the combination group may stop one medication if needed due to side effects but continue the other. Treatment may continue beyond disease progression if clinically beneficial. During the study, participants will have clinic visits at intervals depending on their treatment group, including safety checks and imaging scans to monitor tumor response every eight weeks during the first year, every twelve weeks in the second year, and every six months afterward. Researchers will also track overall survival, hospitalization days, response duration, disease control, and any side effects. Safety assessments will continue up to 90 days after the last dose for those receiving immune checkpoint inhibitors and 30 days for others. Long-term follow-up for survival and anti-cancer treatments will continue for up to five years after treatment ends.

A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma