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

NCT07489495 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 758

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Belzutifan

Tablet for oral administration.

DRUG

Zanzalintinib

Tablet for oral administration.

DRUG

Placebo

Zanzalintinib-matching placebo tablet for oral administration.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-09
Primary Completion
2030-11-27
Completion
2030-11-27
FDA Drug
Yes

Countries

  • Argentina
  • Australia
  • Israel
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07489495 on ClinicalTrials.gov