At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 93 enrolled
Drug / intervention
Pembrolizumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Epacadostat, and 1 other intervention for UC (Urothelial Cancer). Completed, enrolled 93 participants across 143 sites in 18 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUC (Urothelial Cancer)
CountriesAustralia, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartDec 2017
First PostedDec 2017
Primary CompletionAug 2018
Study CompletionAug 2020
TodayJul 2026
First PostedDec 5, 2017
Enrollment StartDec 4, 2017
Primary CompletionAug 9, 2018
Study CompletionAug 4, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.6 years ago
Interventions
Pembrolizumabdrug
Pembrolizumab administered intravenously every 3 weeks.
Epacadostatdrug
Epacadostat administered orally twice daily.
Placebodrug
Matching placebo administered orally twice daily.