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

Inclusion criteria

• 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 criteria

• 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.