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

NCT03374488 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-08-22

Study results available
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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

  • UC (Urothelial Cancer)

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Mark Jones, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-22
Primary Completion
2018-07-27
Completion
2020-07-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03374488 on ClinicalTrials.gov