nivolumab plus cabozantinib (n=323) vs. sunitinib (n=328)
randomized controlled trial
Nivolumab and Cabozantinib
nivolumab 240 mg every 2 weeks plus oral cabozantinib 40 mg daily
Sunitinib
oral sunitinib 50 mg daily in cycles of 4 weeks on therapy/2 weeks off therapy
metastatic/advanced RCC (mRCC) - 1st line (L1)
Patients had any InternationalMetastatic Renal-Cell Carcinoma DatabaseConsortium (IMDC) prognostic risk score18,19 anda Karnofsky performance-status score of at least70 (on a scale from 0 to 100
open label
125 sites in 18 countries
P3/ two sided and two interim analyses (OS). If the between-group difference inprogression-free survival was significant, analysisof overall survival would be performed at an overall alpha level of 0.05 (0.011 at the first interim, 0.025at the second interim, and 0.041 at the finalanalysis with an O’Brien and Fleming alphaspending function). and then ORR with the use of a hierarchicaltesting procedure.
Nivolumab plus cabozantinib had significant benefits over sunitinib with respect to progression-free survival, overall survival, and likelihood of response in patients with previously untreated advanced renal-cell carcinoma.