Study on Belzutifan and Pembrolizumab Versus Placebo and Pembrolizumab for Clear Cell Kidney Cancer After Surgery

Inclusion Criteria

• Diagnosed with clear cell kidney cancer, possibly with sarcomatoid features.
• Classified as intermediate-high risk, high risk, or M1 no evidence of disease (NED) based on specific medical criteria.
• Have had complete removal of the primary kidney tumor and any isolated metastases.
• Surgery (nephrectomy and/or metastasectomy) must have been done within 12 weeks before joining the study.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Male participants must agree to use contraception for at least 7 days after the last dose of belzutifan/placebo.
• Female participants of childbearing potential must use effective contraception during the study and for a specified period after the last dose of pembrolizumab or belzutifan/placebo.
• Must have adequate organ function.

Exclusion Criteria

• Have had major surgery, other than kidney surgery, within 4 weeks before joining the study.
• Have low oxygen levels at rest or need supplemental oxygen.
• Have significant heart disease within 6 months before starting the study.
• Have serious non-healing wounds, ulcers, or bone fractures.
• Require dialysis.
• Have existing brain or bone metastases.
• Have received prior systemic therapy or radiotherapy for kidney cancer.
• Have received a live vaccine within 30 days before starting the study.
• Have an immune deficiency or are on chronic steroid therapy.
• Have another active cancer that required treatment in the past 3 years.
• Have an active autoimmune disease needing treatment in the past 2 years.
• Have a history of lung disease requiring steroids.
• Have an active infection needing treatment.
• Have a history of HIV, Hepatitis B, or active Hepatitis C.
• Have had an organ transplant.