A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)

Prior treatment

• Has deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
• Has had major surgery within 8 weeks before randomization
• Has not adequately recovered from major surgery or has ongoing surgical complications

Other illness

• Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
• Has current pneumonitis/interstitial lung disease
• Has a history of human immunodeficiency virus infection
• Has Hepatitis B or Hepatitis C virus infection
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has a history of solid organ transplant

Lab values

• Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram

Other

• For exclusion criteria: The main exclusion criteria include but are not limited to the following:
• Has any of the following: a pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen

• The main inclusion criteria include but are not limited to the following:
• Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)
• Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
• Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy