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Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention
NCT03817125 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Nivolumab
- DRUG Placebo for antibiotic
- DRUG Vancomycin pretreatment
- DRUG Matching Placebo for SER-401
- DRUG SER-401
Study Locations (7)
Massachusetts
- Massachusetts General Hospital — Boston
- Dana-Farber Cancer Institute — Boston
California
- The Angeles Clinic and Research Institute — Los Angeles
New Jersey
- Rutgers Cancer Institute of New Jersey — New Brunswick
New York
- Memorial Sloan Kettering Cancer Center — New York
Texas
- MD Anderson Cancer Center — Houston
Utah
- Huntsman Cancer Institute — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-01-28 |
| Est. Completion | 2022-03-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03817125
The ClinicalTrials.gov registry entry for NCT03817125 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Parker Institute for Cancer Immunotherapy, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03817125 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Massachusetts, California, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03817125 about?
NCT03817125 is a clinical study titled "Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention". 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 ...
What is the current status of trial NCT03817125?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2019-01-28. Estimated completion is 2022-03-04.
What conditions does trial NCT03817125 study?
This clinical trial studies the following conditions: Metastatic Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03817125?
The interventions under investigation include: Nivolumab (DRUG), Placebo for antibiotic (DRUG), Vancomycin pretreatment (DRUG), Matching Placebo for SER-401 (DRUG), SER-401 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03817125?
This trial is sponsored by Parker Institute for Cancer Immunotherapy, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03817125 being conducted?
This trial has 7 study locations across California, Massachusetts, New Jersey, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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