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NCT03374488 · ClinicalTrials.gov registry record · Phase 3
Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
A Phase 3 study of UC (Urothelial Cancer), sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT03374488: Completed Phase 3 study of UC (Urothelial Cancer), sponsored by Incyte Corporation.
NCT03374488 is a Phase 3 study of UC (Urothelial Cancer) that has completed, run by Incyte Corporation. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03374488, a Phase 3 study of UC (Urothelial Cancer), has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.
Primary Outcome
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Placebo
- DRUG Epacadostat
Study Locations (20)
California
- University of California Irvine Medical Center - Orange
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
- UCLA Hematology Oncology Santa Monica - Santa Monica
Pennsylvania
- University of Pennsylvania - Philadelphia
- Thomas Jefferson University Hospital - Philadelphia
- Fox Chase Cancer Center - Philadelphia
Illinois
- University of Chicago - Chicago
- Quincy Medical Group - Quincy
Tennessee
- University of Tennessee Medical Center Knoxville - Knoxville
- Vanderbilt University Medical Center - Nashville
Arizona
- Ironwood Cancer & Research Centers - Chandler
Connecticut
- Smilow Cancer Center at Yale-New Haven - New Haven
Georgia
- Northside Hospital, Inc. - GCS/Annex - Atlanta
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-12-22 |
| Est. Completion | 2020-07-23 |
| Phase | Phase 3 |
What the finished NCT03374488 record still lists
NCT03374488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 1 condition, with UC (Urothelial Cancer) appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03374488 names 20 study sites across 14 states, led by California, Pennsylvania, Illinois.
Frequently Asked Questions
What is clinical trial NCT03374488 about?
NCT03374488 is a clinical study titled "Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma". The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metas...
What is the current status of trial NCT03374488?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2017-12-22. Estimated completion is 2020-07-23.
What conditions does trial NCT03374488 study?
This clinical trial studies the following conditions: UC (Urothelial Cancer).
What interventions are being tested in trial NCT03374488?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Epacadostat (DRUG).
Who is sponsoring clinical trial NCT03374488?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03374488 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03374488's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 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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