Phase II Study of LND101 Fecal Microbiota Transplant with Immune Checkpoint Blockade in Treating Advanced Melanoma

What this Trial Is About

Researchers are evaluating whether adding a treatment called LND101 for Fecal Microbiota Transplant FMT to the usual immunotherapy called Immune Checkpoint Blockade ICB can reduce the chance of advanced melanoma growing or spreading. This Phase II study compares this combination approach with the standard ICB treatment alone for patients with advanced or unresectable melanoma. Immunotherapy activates the immune system to target cancer cells and may slow tumor growth. Participants will receive either standard ICB, which can be a single drug or combination approved for advanced melanoma, or LND101 capsules taken orally after bowel preparation combined with standard ICB. About 40 capsules containing processed fecal material are given 7 days before starting ICB treatment. The choice of ICB regimen is made before enrollment and remains the same during the study. During the study, participants will be monitored for progression-free survival over 4 years, along with overall survival, response to treatment, and any side effects. Researchers will collect blood and stool samples and may analyze tumor tissue if available. Participants will have regular assessments to track disease and safety, and treatment must begin within 14 days after enrollment. The study is randomized without masking, and participants will be followed closely for treatment effects and side effects.

LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma