A Multicenter Phase 1b Randomized, Placebo-controlled, Blinded Study to Evaluate the Safety, Tolerability and Efficacy of Microbiome Study Intervention Administration in Combination with Anti-PD-1 Therapy in Adult Patients with Unresectable or Metastatic Melanoma
MD Anderson Study Status
Placebo for antibiotic, Vancomycin pretreatment, Nivolumab, Matching Placebo for SER-401, SER-401
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.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Isabella Glitza Oliva
Melanoma Medical Oncology
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