Patient Eligibility
pneumonitis, RPLS, toxicities, clear-cell RCC, non-clear, RCC, autoimmune disease
ADVERSE EVENT, PNEUMONITIS, IMMUNODEFICIENCY, REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME, WOUND DEHISCENCE, ONCOLOGY, OSTEONECROSIS OF THE JAW, AUTOIMMUNE DISEASE, RCC
Eligible patients had histologically confirmed, locally advanced, recurrent, or mRCC. Patients with clear-cell RCC (ccRCC) or non-clear cell RCC (nccRCC) were included. Key inclusion criteria were Eastern Cooperative Oncology Group 0–1 performance status, adequate organ function, and resolution of prior treatment-related toxicities to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 1 or less. Key exclusion criteria were prior treatment with pembrolizumab or cabozantinib; prior anticancer mAb therapy within 4 weeks and prior anticancer targeted small-molecule therapy within 2 weeks of day 1 of study treatment; active autoimmune disease requiring systemic treatment in the past 2 years, diagnosis of immunodeficiency, current systemic steroid therapy equivalent to ≥10 mg/day of prednisone; history of osteonecrosis of the jaw, reversible posterior leukoencephalopathy syndrome (RPLS), pneumonitis, or wound dehiscence within 6 months of study; or uncontrolled or significant intercurrent cardiovascular, gastrointestinal, or pulmonary disorders. There was no requirement or limit on the number of prior anticancer therapies.