CheckMate-025 Phase III trial of Opdivo (nivolumab) from BMS + Ono for renal cell carcinoma is stopped early after showing superior overall survival compared to Afinitor (everolimus)
BMS announced that an open-label, randomized Phase III study evaluating Opdivo (nivolumab) versus Afinitor (everolimus) in previously-treated patients with advanced or metastatic renal cell carcinoma (RCC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving nivolumab compared to the control arm.
CheckMate-025 is a Phase III, open-label, randomized study of nivolumab versus everolimus in previously-treated patients with advanced or metastatic clear-cell renal cell carcinoma. The trial randomized 821 patients to receive either nivolumab 3 mg/kg intravenously every two weeks or everolimus 10 mg tablets daily until documented disease progression or unacceptable toxicity. The primary endpoint was overall survival. Secondary endpoints included objective response rate and progression-free survival.
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