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NCT03291054 · ClinicalTrials.gov registry record · Phase 2
Epacadostat and Pembrolizumab in Patients With GIST
A Phase 2 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT03291054: Clinical Trial Phase 2 study, sponsored by Columbia University.
NCT03291054 is a Phase 2 study that was terminated before completion, run by Columbia University. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03291054, a Phase 2 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Primary objective is to assess the efficacy of combined Indoleamine 2,3-dioxygenase (IDO) and PD-1 inhibition in a single arm phase II trial of epacadostat and pembrolizumab in patients with advanced imatinib-refractory GIST, using a primary endpoint of overall response rate. Secondary objectives are to evaluate the progression free survival (PFS), the overall survival (OS), the response rate and to evaluate the safety and tolerability of combined epacadostat and pembrolizumab treatment. The investigator hypothesizes that treatment with epacadostat and pembrolizumab will increase the response rate compared to what has been historically achieved with salvage tyrosine kinase inhibitors.
Primary Outcome
The primary endpoint is the overall response rate as defined as the best response using RECIST v1.1 criteria. A standard way to measure how well a cancer patient responds to treatment. It is based on whether tumors shrink, stay the same, or get bigger. To use RECIST, there must be at least one tumor that can be measured on x-rays, CT scans, or MRI scans. The types of response a patient can have are a complete response (CR), a partial response (PR), progressive disease (PD), and stable disease (S
Interventions
- DRUG Pembrolizumab
- DRUG Epacadostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-02-28 |
| Est. Completion | 2020-08-19 |
| Phase | Phase 2 |
Why NCT03291054 stopped before completion
NCT03291054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03291054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03291054 about?
NCT03291054 is a clinical study titled "Epacadostat and Pembrolizumab in Patients With GIST". Primary objective is to assess the efficacy of combined Indoleamine 2,3-dioxygenase (IDO) and PD-1 inhibition in a single arm phase II trial of epacadostat and pembrolizumab in patients with advanced imatinib-refractory GIST, using a primary endpoint of overall response rate. Secondary objectives a...
What is the current status of trial NCT03291054?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2018-02-28. Estimated completion is 2020-08-19.
What interventions are being tested in trial NCT03291054?
The interventions under investigation include: Pembrolizumab (DRUG), Epacadostat (DRUG).
Who is sponsoring clinical trial NCT03291054?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03291054's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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