Back to search results

A Study of Belzutifan and Zanzalintinib for Advanced Kidney Cancer

Researchers are studying new ways to treat advanced renal cell carcinoma (RCC), which is a type of kidney cancer. This study is testing if adding zanzalintinib to belzutifan, both targeted therapies, can better treat advanced RCC than belzutifan alone. Targeted therapies work by focusing on specific ways cancer cells grow and spread. You may be able to join if you have advanced RCC that has been confirmed by a biopsy and is measurable. The study aims to see if people who receive both belzutifan and zanzalintinib live longer overall and without their cancer getting worse. The current status of this study is unclear.

Study design
This interventional study plans to enroll 758 participants. It compares belzutifan plus zanzalintinib to belzutifan plus a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival for up to approximately 30 months and for overall survival for up to approximately 50 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07489495

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~758 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:BelzutifanZanzalintinibPlacebo

At a glance

Recruiting sites
65 of 66 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS)
Measured over Up to approximately 30 months
+1 more outcome measured

Conditions

Carcinoma, Renal Cell

Explore related trials

Renal Cell Carcinoma

Where it's being run

66 sites across 42 states
Israel4
Italy4
Spain4
Turkey (Türkiye)4
Buenos Aires3
Argentina3
Attica3
South Korea3

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)
Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy

Exclusion

Has any of the following: a pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
Has deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
Has had major surgery within 8 weeks before randomization
Has current pneumonitis/interstitial lung disease
Has a history of human immunodeficiency virus infection
Has Hepatitis B or Hepatitis C virus infection
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has a history of solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications

What this trial measures

  • Progression-free Survival (PFS)Up to approximately 30 months

    PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first.

  • Overall Survival (OS)Up to approximately 50 months

    OS is defined as the time from randomization to death due to any cause.