Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention
Status:
Active, not recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
This study is designed to evaluate the safety and tolerability of treatment with oral
microbiome study intervention (SER-401) or matching placebo in combination with
anti-programmed cell death 1 (anti-PD-1) therapy (nivolumab) in participants with
unresectable or metastatic melanoma. The study also intends to assess clinical outcomes, the
impact of microbiome study intervention administration on the microbiome profile, and its
association with clinical and immunological outcomes.