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An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination with Lenvatinib, versus Pembrolizumab and Lenvatinib, as First

Primary Objectives - Objective: To compare the HIF triplet to the doublet with respect to PFS per RECIST 1.1 as assessed by BICR. - Hypothesis (H1): The HIF triplet is superior to the doublet with respect to PFS per RECIST 1.1 by BICR in advanced ccRCC patients with IMDC intermediate/poor risk. - Hypothesis (H2): The HIF triplet is superior to the doublet with respect to PFS per RECIST 1.1 by BICR in all advanced ccRCC patients. - Objective: To compare the HIF triplet to the doublet with respect to OS. - Hypothesis (H3): The HIF triplet is superior to the doublet with respect to OS in advanced ccRCC patients with IMDC intermediate/poor risk. - Hypothesis (H4): The HIF triplet is superior to the doublet with respect to OS in all advanced ccRCC patients. - Objective: To compare the CTLA4 triplet to the doublet with respect to PFS per RECIST 1.1 as assessed by BICR. - Hypothesis (H5): The CTLA4 triplet is superior to the doublet with respect to PFS per RECIST 1.1 by BICR in advanced ccRCC patients with IMDC intermediate/poor risk. - Hypothesis (H6): The CTLA4 triplet is superior to the doublet with respect to PFS per RECIST 1.1 by BICR in all advanced ccRCC patients. Objective: To compare the CTLA4 triplet to the doublet with respect to OS. - Hypothesis (H7): The CTLA4 triplet is superior to the doublet with respect to OS in advanced ccRCC patients with IMDC intermediate/poor risk. - Hypothesis (H8): The CTLA4 triplet is superior to the doublet with respect to OS in all advanced ccRCC patients.

Phase

III

Recruitment Status

Current Studies