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Exelixis and Bristol-Myers Squibb have announced that they have initiated a phase III trial, called CheckMate 9ER, to evaluate the immunotherapy drug nivolumab (Opdivo) in combination with cabozantinib (Cabometyx) or nivolumab and ipilimumab (Yervoy) in combination with cabozantinib versus sunitinib in patients with previously untreated, advanced or metastatic renal cell carcinoma (RCC).
The primary endpoint for the trial is progression-free survival (PFS).
The open-label, randomised, multi-national phase III trial will enroll approximately 1,014 patients with previously untreated advanced or metastatic RCC. Patients will be randomised 1:1:1 to one of the three arms: cabozantinib and nivolumab, cabozantinib, nivolumab and ipilimumab, or sunitinib. The primary efficacy analysis will compare the doublet combination versus sunitinib and the triplet combination versus sunitinib in intermediate/poor risk patients with renal cell carcinoma (RCC).