A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
CABA, Buenos Aires C1120AAT, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires 1181, Argentina
CABA, 1426, Argentina
Osakasayamashi, Osaka 5898511, Japan
Suita-shi, Osaka 565-0871, Japan
Hidaka-shi, Saitama 3501298, Japan
Adachi-ku, Tokyo 123-8558, Japan
Bunkyo-ku, Tokyo 1138519, Japan
Bunkyo-ku, Tokyo 1138603, Japan
Minato-ku, Tokyo 105-8470, Japan