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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-line Treatment in Participants with Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
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.
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.
Recruitment Status
Past Studies