A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Prior treatment

• Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
• Participants who have received a live/attenuated vaccine within 30 days of first treatment
  • Other protocol defined inclusion/exclusion criteria could apply

Other illness

• Any active, known or suspected autoimmune disease

Other

• Any active CNS metastases

• Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
• Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
• No prior systemic therapy for RCC with the following exception:
  • One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

Criteria the registry did not label

• For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com