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A Multi-center, Double-Blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) plus Pembrolizumab (MK-3475) Versus Placebo plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (6482-022)

Primary To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab Hypothesis (1): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS Secondary To compare overall survival (OS) for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab Hypothesis (2): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to OS To compare the safety and tolerability profiles for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab To compare measures of disease recurrence-specific survival (DRSS) as assessed by the investigator, in participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab To evaluate change from baseline in health-related quality of life (HRQoL) and symptoms using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life 30 Questionnaire (QLQ-C30) and the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-related Symptoms (FKSI-DRS) Tertiary/Exploratory To evaluate pharmacokinetic (PK) parameters To evaluate PROs with the EORTC QLQ-C30, FKSI-DRS, and EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) To identify molecular (genomic, metabolic, and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of belzutifan and pembrolizumab To investigate the relationship between the genetic polymorphisms of UGT2B17 and cytochrome P450 2C19 (CYP2C19) and the PK of belzutifan. Variation in UDP-glucuronosyltransferase 2B17 (UGT2B17) and CYP2C19 alleles may be analyzed for association with any laboratory or clinical data collected in this study

Primary To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab Hypothesis (1): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS Secondary To compare overall survival (OS) for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab Hypothesis (2): Belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to OS To compare the safety and tolerability profiles for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab To compare measures of disease recurrence-specific survival (DRSS) as assessed by the investigator, in participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab To evaluate change from baseline in health-related quality of life (HRQoL) and symptoms using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life 30 Questionnaire (QLQ-C30) and the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-related Symptoms (FKSI-DRS) Tertiary/Exploratory To evaluate pharmacokinetic (PK) parameters To evaluate PROs with the EORTC QLQ-C30, FKSI-DRS, and EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) To identify molecular (genomic, metabolic, and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of belzutifan and pembrolizumab To investigate the relationship between the genetic polymorphisms of UGT2B17 and cytochrome P450 2C19 (CYP2C19) and the PK of belzutifan. Variation in UDP-glucuronosyltransferase 2B17 (UGT2B17) and CYP2C19 alleles may be analyzed for association with any laboratory or clinical data collected in this study