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NCT03595683 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and EDP1503 in Advanced Melanoma
A Phase 2 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT03595683: Clinical Trial Phase 2 study, sponsored by University of Chicago.
NCT03595683 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03595683, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study is being done to determine if orally administered EDP1503 will enhance the response to standard immunotherapy treatment (pembrolizumab) in participants with advanced melanoma. The study will involve initial administration of EDP1503 for a run-in period (2 weeks) followed by administration of both EDP1503 (twice daily) and pembrolizumab (every 3 weeks). Mandatory biopsies are required before starting study treatment and after 2 weeks of EDP1503 dosing.
Primary Outcome
For Cohort 1, based on deep response (\>80% tumor reduction). Assessed by standard RECIST criteria for Cohort 2 (complete + partial response).
Interventions
- DRUG Pembrolizumab
- BIOLOGICAL EDP1503
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-10-02 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 2 |
Why NCT03595683 stopped before completion
NCT03595683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03595683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03595683 about?
NCT03595683 is a clinical study titled "Pembrolizumab and EDP1503 in Advanced Melanoma". This study is being done to determine if orally administered EDP1503 will enhance the response to standard immunotherapy treatment (pembrolizumab) in participants with advanced melanoma. The study will involve initial administration of EDP1503 for a run-in period (2 weeks) followed by administratio...
What is the current status of trial NCT03595683?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2018-10-02. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT03595683?
The interventions under investigation include: Pembrolizumab (DRUG), EDP1503 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03595683?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03595683's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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