A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib or Nivolumab and Ipilimumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

Full Name

MSK 17-520 (CA209-9ER): A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib or Nivolumab and Ipilimumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

Description

Experimental: Arm A (Doublet)

Interventions:
Biological: Nivolumab
Drug: Cabozantinib

Experimental: Arm B (Triplet)

Interventions:
Biological: Nivolumab
Biological: Ipilimumab
Drug: Cabozantinib

Experimental: Arm C

Intervention:
Drug: Sunitinib

Eligibility

Inclusion Criteria

Includes but may not be limited to:

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:

i) 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

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

Exclusion Criteria

Any active CNS metastases

Any active, known or suspected autoimmune disease

Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization

Other protocol defined inclusion/exclusion criteria could apply