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NCT03817125 · ClinicalTrials.gov registry record · Phase 1
Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention
A Phase 1 study of Metastatic Melanoma, sponsored by Parker Institute for Cancer Immunotherapy.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 7
- Study locations
NCT03817125 is a Phase 1 study of Metastatic Melanoma that has completed, run by Parker Institute for Cancer Immunotherapy. The registered enrollment target is 14 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (83% lower). The trial reports 7 study locations across 6 states.
The verdict
NCT03817125, a Phase 1 study of Metastatic Melanoma, has completed, sponsored by Parker Institute for Cancer Immunotherapy.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 7
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (83% lower). The listed sponsor is Parker Institute for Cancer Immunotherapy, which has 5 total studies on file at ClinicalTrials.gov.
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.
NCT03817125 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Massachusetts, California, New Jersey.
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.
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).
Who is sponsoring clinical trial NCT03817125?
This trial is sponsored by Parker Institute for Cancer Immunotherapy, which has 5 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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