Clinical Trial

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

Recruiting Phase 3

Summary

Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC). A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone. The goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.

Protocol Amendment History 12 changes

notable Trial sites expanded: 69 -> 78 locations 2026-08-15

notable Trial sites expanded: 66 -> 69 locations 2026-08-11

notable Trial sites expanded: 59 -> 66 locations 2026-07-28

notable Trial sites expanded: 52 -> 59 locations 2026-07-21

notable Trial sites expanded: 47 -> 52 locations 2026-07-11

notable Trial sites expanded: 41 -> 47 locations 2026-07-07

notable Trial sites expanded: 34 -> 39 locations 2026-06-24

notable Trial sites expanded: 25 -> 34 locations 2026-06-12

notable Trial sites expanded: 20 -> 25 locations 2026-06-09

notable Trial sites expanded: 13 -> 20 locations 2026-05-30

notable Trial sites expanded: 8 -> 13 locations 2026-05-27

critical Recruitment opened 2026-04-24

Trial Details

NCT Number	NCT07489495
Lead Sponsor	Merck Sharp & Dohme LLC Collaborators: Exelixis
Conditions	Carcinoma, Renal Cell
Enrollment	758 participants
Start Date	2026-04-09
Primary Completion	2030-11-27 (estimated)
Study Completion	2030-11-27 (estimated)
Updated on ClinicalTrials.gov	2026-08-14