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NCT03260894 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Renal Cell Carcinoma (RCC), sponsored by Incyte Corporation.

Completed
Registry status
Phase 3
Development phase
129
Enrollment target
20
Study locations

NCT03260894: Completed Phase 3 study of Renal Cell Carcinoma (RCC), sponsored by Incyte Corporation.

NCT03260894 is a Phase 3 study of Renal Cell Carcinoma (RCC) that has completed, run by Incyte Corporation. The registered enrollment target is 129 participants, below the 401-participant average among 12 other Renal Cell Carcinoma (RCC) trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03260894, a Phase 3 study of Renal Cell Carcinoma (RCC), has completed, sponsored by Incyte Corporation.

COMPLETED
Registry status
Phase 3
Development phase
129 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.

Conditions Studied

Interventions

  • DRUG Pembrolizumab
  • DRUG Epacadostat
  • DRUG Sunitinib
  • DRUG Pazopanib

Study Locations (20)

Arizona

  • Pinnacle Oncology Hematology - Scottsdale
  • Scottsdale Healthcare - Scottsdale
  • Arizona Oncology Associates PC- HOPE - Tucson

California

  • Cedars-Sinai Medical Center - Los Angeles
  • UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center - Orange
  • UC Davis Comprehensive Cancer Center - Sacramento

Georgia

  • Northside Hospital - Atlanta
  • Atlanta Cancer Care - Conyers - Conyers
  • Northwest Georgia Oncology Centers Pc - Marietta

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston

New York

  • New York Oncology Hematology P.C - Albany
  • Memorial Sloan Kettering Cancer Center - New York

Tennessee

  • University of Tennessee Erlanger Oncology & Hematology - Chattanooga
  • The West Clinic, P.C. - Germantown

Florida

  • Woodlands Medical Specialists, PA - Pensacola

Illinois

  • Rush University Medical Center - Chicago

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2017-12-07
Est. Completion 2025-06-04
Phase Phase 3
Incyte Corporation

239 total trials

What the finished NCT03260894 record still lists

NCT03260894 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 401-participant average among 12 other Renal Cell Carcinoma (RCC) trials with a reported enrollment target (68% lower).

The record links to 1 condition, with Renal Cell Carcinoma (RCC) appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT03260894 names 20 study sites across 11 states, led by Arizona, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT03260894 about?

NCT03260894 is a clinical study titled "Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)". 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.

What is the current status of trial NCT03260894?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2017-12-07. Estimated completion is 2025-06-04.

What conditions does trial NCT03260894 study?

This clinical trial studies the following conditions: Renal Cell Carcinoma (RCC).

What interventions are being tested in trial NCT03260894?

The interventions under investigation include: Pembrolizumab (DRUG), Epacadostat (DRUG), Sunitinib (DRUG), Pazopanib (DRUG).

Who is sponsoring clinical trial NCT03260894?

This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03260894 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Renal Cell Carcinoma (RCC)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03260894's enrollment target sits among peer trials

129 6th of 12 higher than 7 of 12 other Renal Cell Carcinoma (RCC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Renal Cell Carcinoma (RCC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03260894, the US trial registry maintained by the National Library of Medicine. NCT03260894 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.