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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: Completed Phase 1 study of Metastatic Melanoma, sponsored by Parker Institute for Cancer Immunotherapy.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Investigators recorded AEs during each participant interaction. Symptoms were evaluated by the Investigator using the CTCAE version 5.0. This system grades AEs on a 1 to 5 scale: Grades 1 and 2 indicate mild to moderate events; Grade 3 denotes severe events; Grades 4 and 5 signify life-threatening or fatal outcomes. A treatment-emergent adverse event (TEAE) is defined as any event that either occurs after the initiation of study intervention, having been absent at baseline, or, if present at ba
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 |
What the finished NCT03817125 record still lists
NCT03817125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (83% lower).
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 lists 7 locations in 6 states (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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Where NCT03817125's enrollment target sits among peer trials
14 83rd of 91 higher than 8 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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