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Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention

NCT03817125 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-06-06

Study results available
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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.

Conditions

Interventions

DRUG

Placebo for antibiotic

Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout.

DRUG

Vancomycin pretreatment

Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout.

DRUG

Nivolumab

Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks.

DRUG

Matching Placebo for SER-401

Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.

DRUG

SER-401

Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.

Sponsors & Collaborators

  • Seres Therapeutics, Inc.

    collaborator INDUSTRY

  • Parker Institute for Cancer Immunotherapy

    lead OTHER

Principal Investigators

  • Parker Institute for Cancer Immunotherapy · Parker Institute for Cancer Immunotherapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2022-03-04
Completion
2022-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03817125 on ClinicalTrials.gov