NCT07227402

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 904 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib. The goal of this study is to learn if: People who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Belzutifan	Administered orally QD
DRUG	Zanzalintinib	Administered orally QD
DRUG	Cabozantinib	Administered orally QD

Timeline

• Start date: 2025-11-26
• Primary completion: 2032-02-27
• Completion: 2032-02-27
• First posted: 2025-11-12
• Last updated: 2026-04-17

Locations

102 sites across 19 countries: Argentina, Australia, Austria, Belgium, Brazil, Czechia, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Mexico, Poland, Singapore, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study