Actively Recruiting
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-12
758
Participants Needed
7
Research Sites
241 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features), Stage IV RCC
- Measurable disease per RECIST 1.1 criteria
- Received no more than 3 prior systemic treatments for RCC, including only 1 prior anti-PD-1/PD-L1 therapy
You will not qualify if you...
- Pulse oximeter reading less than 92% at rest or requiring intermittent or chronic supplemental oxygen
- Clinically significant cardiovascular disease within 12 months before first dose
- Deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and adequately treated
- Left ventricular ejection fraction 50% or below institutional normal range
- Major surgery within 8 weeks before randomization
- Current pneumonitis or interstitial lung disease
- History of HIV infection
- Hepatitis B or Hepatitis C virus infection
- Known additional malignancy progressing or requiring active treatment within past 3 years
- History of solid organ transplant
- Not fully recovered from major surgery or has ongoing surgical complications
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)
Río Cuarto, Córdoba Province, Argentina, X5800ALB
Actively Recruiting
2
Centro Oncológico Riojano Integral ( Site 0256)
La Rioja, Argentina, X5004BAL
Actively Recruiting
3
Macquarie University ( Site 2700)
Macquarie University, New South Wales, Australia, 2109
Suspended
4
Rambam Health Care Campus ( Site 1600)
Haifa, Israel, 3109601
Actively Recruiting
5
Sheba Medical Center ( Site 1601)
Ramat Gan, Israel, 5265601
Actively Recruiting
6
Severance Hospital, Yonsei University Health System ( Site 2903)
Seoul, South Korea, 03722
Actively Recruiting
7
Samsung Medical Center ( Site 2902)
Seoul, South Korea, 06351
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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