Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC

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.