2018
Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma
Abstract: BACKGROUND Nivolumab plus ipilimumab produced objective responses in patients with advanced renal-cell carcinoma in a pilot study. This phase 3 trial compared nivolumab plus ipilimumab with sunitinib for previously untreated clear-cell advanced renal-cell carcinoma. METHODS We randomly assigned adults in a 1:1 ratio to receive either nivolumab (3 mg per kilogram of body weight) plus ipilimumab (1 mg per kilogram) intravenously every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram) every 2 we…
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Cited by 4,458 publications
(3,796 citation statements)
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“…Our findings appear to contrast with the results of the pivotal CheckMate 214 trial ( 8 ). Several factors may help explain this difference.…”
Section: Discussioncontrasting
confidence: 99%
“…Our findings appear to contrast with the results of the pivotal CheckMate 214 trial ( 8 ). Several factors may help explain this difference.…”
Section: Discussioncontrasting
confidence: 99%
“…Consistent with previous reports, 3 8 similar overall rates of treatment-related AEs of any grade occurred in the NIVO+IPI and SUN arms with extended follow-up (514/547 (94.0%) vs 521/535 (97.4%) patients). Yet, there were fewer grade 3–4 treatment-related AEs with NIVO+IPI versus SUN (47.3% vs 64.1%; online supplementary table S3 ).…”
Section: Resultssupporting
confidence: 90%
“…The predictive relevance of PD-L1 expression on IC is further supported by the strong correlation of PD-L1 IC as determined by IHC with the T eff immune gene signature. These findings are consistent with results from other recently reported studies in mRCC 38,39 . Specifically, in a phase 3 study evaluating ipilimumab + nivolumab versus sunitinib, improved clinical benefit was observed in patients expressing PD-L1 on tumor cells (24% of enrolled patients) 39 .…”
Section: Discussionsupporting
confidence: 94%
“…These findings are consistent with results from other recently reported studies in mRCC 38,39 . Specifically, in a phase 3 study evaluating ipilimumab + nivolumab versus sunitinib, improved clinical benefit was observed in patients expressing PD-L1 on tumor cells (24% of enrolled patients) 39 . These data support development of PD-L1 IHC and/or an immune gene expression signature based diagnostic or enrichment strategy in treatment-naive patients with mRCC.…”
Section: Discussionsupporting
confidence: 94%
