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NCT03361865 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
A Phase 3 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 93
- Enrollment target
NCT03361865: Completed Phase 3 study, sponsored by Incyte Corporation.
NCT03361865 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 93 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03361865, a Phase 3 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 93 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.
Primary Outcome
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination. Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date.
Interventions
- DRUG Pembrolizumab
- DRUG Placebo
- DRUG Epacadostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2020-08-04 |
| Phase | Phase 3 |
What the finished NCT03361865 record still lists
NCT03361865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03361865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03361865 about?
NCT03361865 is a clinical study titled "Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)". The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.
What is the current status of trial NCT03361865?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 93 participants. The study started on 2017-12-04. Estimated completion is 2020-08-04.
What interventions are being tested in trial NCT03361865?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Epacadostat (DRUG).
Who is sponsoring clinical trial NCT03361865?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03361865's enrollment target sits among peer trials
93 1722nd of 2000 higher than 278 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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