Trials / Completed
CompletedNCT03374488
Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
A Phase 3 Randomized, Double-Blind Clinical Study 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 (KEYNOTE-698/ECHO-303)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. |
| DRUG | Epacadostat | Epacadostat administered orally twice daily. |
| DRUG | Placebo | Matching placebo administered orally twice daily. |
Timeline
- Start date
- 2017-12-22
- Primary completion
- 2018-07-27
- Completion
- 2020-07-23
- First posted
- 2017-12-15
- Last updated
- 2025-08-22
- Results posted
- 2019-08-28
Locations
135 sites across 18 countries: United States, Australia, Canada, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03374488. Inclusion in this directory is not an endorsement.