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

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.