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Carcinoma, Renal CellCancerDrugPhase 3

What this study is

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.

What's being tested

  • Belzutifan

    Intervention · DRUG

  • Zanzalintinib

    Intervention · DRUG

  • Placebo

    Intervention · DRUG

    Zanzalintinib-matching placebo tablet for oral administration.

Both Belzutifan and Zanzalintinib

Tablet for oral administration.

Study details

Official title
A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)
Sponsor
Merck Sharp & Dohme LLC
Conditions
Carcinoma, Renal Cell
Enrolling
758 people
Starts
2026-04-09
Est. completion
2030-11-27
Design
Triple-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗