A Multicenter, 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 (MK-6482-022)

Inclusion Criteria:

• Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features

• Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:

  1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
  2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
  3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
• Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
• Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
• ECOG PS 0-1
• Must not have a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
• No clinically significant cardiovascular disease within 6 months from first dose of study intervention
• No preexisting brain or bone metastatic lesions
• No prior systemic therapy for RCC
• No prior radiotherapy for RCC
• No diagnosis of immunodeficiency or receiving chronic systemic steroid therapy
• No known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
• No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy is allowed
• No history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• No known HIV/HBV/HCV

• Primary
  • DFS
• Secondary
  • OS
  • Toxicity
  • Disease Recurrence Free Survival 1
  • Disease Recurrence Free Survival 2
  • QOL