CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 84 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.

Search/NCT03374488
NCT03374488Phase 3Completed
CompareCT.gov

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)

Incyte Corporation·interventional·Posted Dec 15, 2017·Updated Aug 22, 2025

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Epacadostat, and 1 other intervention for UC (Urothelial Cancer). Completed, enrolled 84 participants across 135 sites in 18 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUC (Urothelial Cancer)
CountriesAustralia, Canada, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 15, 2017
Enrollment StartDec 22, 2017
Primary CompletionJul 27, 2018
Study CompletionJul 23, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.5 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks.

Epacadostatdrug

Epacadostat administered orally twice daily.

Placebodrug

Matching placebo administered orally twice daily.