Status:
COMPLETED
Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
Lead Sponsor:
Incyte Corporation
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Renal Cell Carcinoma (RCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 carci...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2025
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03260894
Start Date
December 7 2017
End Date
June 4 2025
Last Update
July 29 2025
Active Locations (140)
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1
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
2
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
3
Arizona Oncology Associates PC- HOPE
Tucson, Arizona, United States, 85711
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048