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-cellcomponent 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 tumorlesion 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 studyof an investigational agent or has used an investigational device within 4 weeksbefore 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 inthe last 3 years.

• Known active central nervous system metastases and/or carcinomatous meningitis.

• History of (noninfectious) pneumonitis that required steroids or currentpneumonitis.

• History or presence of an abnormal electrocardiogram that, in the investigator'sopinion, is clinically meaningful.

• Significant cardiac event within 12 months before Cycle 1 Day 1.