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

Part of paid clinical trials in Marietta, Georgia.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07489495
Phase
PHASE3
Status
Recruiting
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Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belzutifan — DRUG
    Tablet for oral administration.
  • Zanzalintinib — DRUG
    Tablet for oral administration.
  • Placebo — DRUG
    Zanzalintinib-matching placebo tablet for oral administration.

Study Details

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.

Key Dates

First listed
Mar 24, 2026
Start date
Apr 9, 2026
Status verified
Jul 2026
Primary completion
Nov 27, 2030
Completion
Nov 27, 2030

Study Design

Enrollment
758 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Belzutifan + Zanzalintinib
    Participants will receive 120 mg belzutifan orally and 60 mg zanzalintinib once daily for approximately 24 months.
  • Active Comparator: Belzutifan + Placebo
    Participants will receive 120 mg belzutifan orally and zanzalintinib-matching placebo once daily for approximately 24 months.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to approximately 30 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)MariettaGeorgia30060
Study Coordinator
770-281-5124
The West Clinic, P.C. ( Site 0115)GermantownTennessee38138
Study Coordinator
901-683-0055

Find similar trials in Marietta, GA

By research site
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital· Marietta, GAThe West Clinic, P.C.· Germantown, TN

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