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Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)

NCT03260894 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2026-05-22

Study results available
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Summary

The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC.

Conditions

  • Renal Cell Carcinoma (RCC)

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg administered intravenously every 3 weeks.

DRUG

Epacadostat

Epacadostat 100 mg administered orally twice daily.

DRUG

Sunitinib

Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.

DRUG

Pazopanib

Pazopanib 800 mg administered orally once 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
2017-12-07
Primary Completion
2018-08-22
Completion
2025-06-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Chile
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Japan
  • New Zealand
  • Norway
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • 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 NCT03260894 on ClinicalTrials.gov