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

Completed · Phase 3

Conditions studied: Renal Cell Carcinoma (RCC)

In brief

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.

Key facts

Study ID

NCT03260894

Run by

Incyte Corporation

People needed

129

Starts

2017-12-07

Expected to finish

2025-06-04

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic confirmation of locally advanced or metastatic RCC with a clear-cell component with or without sarcomatoid features.
• Must not have received any prior systemic therapy for their mRCC.
• Measurable disease based on RECIST v1.1.
• Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion as required.
• Karnofsky performance status ≥ 70%.
• Adequate organ function per protocol-defined criteria.

You may not qualify if…

• Use of protocol-defined prior/concomitant therapy.
• Currently receiving or has received an investigational treatment as part of a study of an investigational agent or has used an investigational device within 4 weeks before randomization.
• History of severe hypersensitivity reaction to study treatments or their excipients.
• Active autoimmune disease that has required systemic treatment in past 2 years.
• Known additional malignancy that has progressed or has required active treatment in the last 3 years.
• Known active central nervous system metastases and/or carcinomatous meningitis.
• History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
• History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
• Significant cardiac event within 12 months before Cycle 1 Day 1.

Where it is running

• Scottsdale Healthcare — Scottsdale, Arizona, United States
• Arizona Oncology Associates PC- HOPE — Tucson, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UC Irvine Comprehensive Cancer Center/Chao Family Comprehensive Cancer Center — Orange, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• Woodlands Medical Specialists, PA — Pensacola, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Atlanta Cancer Care - Conyers — Conyers, Georgia, United States
• Northwest Georgia Oncology Centers Pc — Marietta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Southeast Nebraska Hematology & Oncology Consultants, P.C. — Lincoln, Nebraska, United States
• New York Oncology Hematology P.C — Albany, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Willamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States
• University of Tennessee Erlanger Oncology & Hematology — Chattanooga, Tennessee, United States
• The West Clinic, P.C. — Germantown, Tennessee, United States
• US Oncology and Research — The Woodlands, Texas, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care — Roanoke, Virginia, United States
• Shenandoah Oncology, P.C. — Winchester, Virginia, United States
• Pinnacle Oncology Hematology — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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