Study #2018-1033
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
MD Anderson Study Status
Not Accepting
Treatment Agent
Placebo for antibiotic, Nivolumab, Matching Placebo for SER-401, Vancomycin pretreatment, SER-401
Description
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
Disease:
Metastatic Melanoma
Study phase:
Phase I
Physician name:
Isabella Glitza Oliva
Department:
Melanoma Medical Oncology
For general questions about clinical trials:
1-855-401-1031
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