A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
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 vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Exclusion Criteria:
Capital Federal, Buenos Aires 1431, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires 1181, Argentina
CABA, 1426, Argentina
Wilton, CORK 0, Ireland
Osakasayamashi, Osaka 5898511, Japan
Suita-shi, Osaka 565-0871, Japan
Bunkyo-ku, Tokyo 113-8603, Japan
Bunkyo-ku, Tokyo 1138431, Japan
Bunkyo-ku, Tokyo 1138655, Japan
Koto-ku, Tokyo 1358550, Japan
Shinjuku-Ku, Tokyo 1608582, Japan
Shinjuku-ku, Tokyo 1628666, Japan