Trials / Completed
CompletedNCT03361865
Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | Pembrolizumab administered intravenously every 3 weeks. |
| DRUG | Epacadostat | Epacadostat administered orally twice daily. |
| DRUG | Placebo | Matching placebo administered orally twice daily. |
Timeline
- Start date
- 2017-12-04
- Primary completion
- 2018-08-09
- Completion
- 2020-08-04
- First posted
- 2017-12-05
- Last updated
- 2025-08-22
- Results posted
- 2019-08-29
Locations
143 sites across 18 countries: United States, Australia, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03361865. Inclusion in this directory is not an endorsement.