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nivolumab alone (n=-9) vs. nivolumab plus ipilimumab (n=-9)
randomized controlled trial
Nivolumab plus ipilimumab
Placebo
metastatic/advanced RCC (mRCC) - (neo)adjuvant(NA)
double-blind
Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab), as adjuvant treatment of localized renal cell carcinoma or RCC, did not meet the primary endpoint.
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.
nivolumab alone (n=410) vs. everolimus (n=411)
randomized controlled trial
nivolumab
3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks
everolimus
10-mg everolimus tablet orally once daily
Dose modifications were not permitted for nivolumab but were permitted for everolimus
metastatic/advanced RCC (mRCC) - 2nd line (L2)
Key exclusion criteria were metastasis to the central nervous system, previous treatment with an mTOR inhibitor. All patients had a Karnofsky performance status of at least 70 at the time of study entry
open-label
146 sites in 24 countries in North America, Europe, Australia, South America, and Asia;
P3 / two-sided test procedure with one interim analysis. Hierarchical statistical testing procedure (OS then PFS)
Among patients with previously treated advanced renal-cell carcinoma, overall survival was significantly longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus.
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