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Completed Phase 3 Interventional Results available

Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

ClinicalTrials.gov ID: NCT03374488

Public ClinicalTrials.gov record NCT03374488. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 11:22 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03374488
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Incyte Corporation
Industry
Enrollment
84 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 22, 2017 (Actual)
Primary completion
Jul 27, 2018 (Actual)
Completion
Jul 23, 2020 (Actual)
Last update posted
Aug 22, 2025

2017 – 2020

United States locations

U.S. sites
24
U.S. states
16
U.S. cities
22
Facility City State ZIP Site status
Ironwood Cancer & Research Centers Chandler Arizona 85224 —
University of California Irvine Medical Center Orange California 92868 —
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California 94158 —
UCLA Hematology Oncology Santa Monica Santa Monica California 90404 —
Smilow Cancer Center at Yale-New Haven New Haven Connecticut 06510 —
Northside Hospital, Inc. - GCS/Annex Atlanta Georgia 30341 —
University of Chicago Chicago Illinois 60637 —
Quincy Medical Group Quincy Illinois 62301 —
Johns Hopkins University Baltimore Maryland 21287 —
Massachusetts General Hospital Boston Massachusetts 02114 —
University of Michigan Health System Ann Arbor Michigan 48109 —
NYU Clinical Cancer Center New York New York 10016 —
Oklahoma Cancer Specialists & Research Institute Tulsa Oklahoma 74146 —
Oregon Health & Science University Portland Oregon 97210 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —
Medical University of South Carolina-Hollings Cancer Center Charleston South Carolina 29425 —
University of Tennessee Medical Center Knoxville Knoxville Tennessee 37920 —
Vanderbilt University Medical Center Nashville Tennessee 37203 —
US Oncology and Research Fort Worth Texas 76177 —
Virginia Cancer Specialists, PC Fairfax Virginia 22031 —
Virginia Oncology Associates Norfolk Virginia 23502 —
VCU Massey Cancer Center Richmond Virginia 23298 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 111 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03374488, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 22, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03374488 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →