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The results from the recent phase III CheckMate-214 clinical trial comparing a combination of nivolumab (Opdivo) and ipilimumab (Yervoy) with sunitinib (Sutent) was not successful in meeting one of its primary objectives; the nivolumab/ipilimumab combination failed to significantly improve progression-free survival (PFS) compared to sunitinib in intermediate and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).
However, there was some improvement in PFS with the combination treatment compared to sunitinib, although this improvement was not statistically significant. The median PFS 11.56 months for the nivolumab/ipilimumab combination versus 8.38 months for sunitinib.
The CheckMate-214 trial did, however, meet the second of its primary objectives and improved objective response rate (ORR), which was 41.6 % for the nivolumab/ipilimumab combination versus 26.5 % for sunitinib.