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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 is a Phase 2 study that was terminated before completion, run by Columbia University. The registered enrollment target is 1 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03291054
The ClinicalTrials.gov registry entry for NCT03291054 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03291054 reports 0 study locations.
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.
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