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Taking people in NetherlandsPhase 3

Belzutifan with zanzalintinib or placebo in advanced kidney cancer after earlier treatments

Tests adding zanzalintinib to belzutifan in adults with advanced renal cell carcinoma.

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
's-Gravenhage, Amsterdam, Maastricht, and Schiedam, NetherlandsSee the 4 sitesAlso in 18 other countries, 110 sites
Trial code
Registry title
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Status
Recruiting
Phase
Phase 3
People taking part
758 people, planned
Started
9 Apr 2026
Expected to end
27 Nov 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Belzutifan
  • Zanzalintinib
  • Placebo
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced kidney cancer (clear cell renal cell carcinoma) that cannot be removed by surgery and has not been controlled by earlier treatments.

Age
18 years or older
Sex
All sexes can join
Disease stage
Unresectable, advanced renal cell carcinoma with a clear cell component (with or without sarcomatoid features), Stage IV, with measurable disease per RECIST 1.1
Earlier treatment
No more than 3 earlier systemic treatments for RCC, including only 1 earlier anti-PD-1/PD-L1 therapy

Main reasons for not taking part

  • Lung problems: pulse oximeter reading below 92% at rest, or needs supplemental oxygen
  • Clinically significant heart or blood vessel disease within 12 months, or left ventricular ejection fraction of 50% or lower
  • Current pneumonitis or interstitial lung disease
  • History of HIV infection, or Hepatitis B or Hepatitis C infection
  • History of solid organ transplant

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • The main inclusion criteria include but are not limited to the following:
  • 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

Who cannot take part

  • 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 had major surgery within 8 weeks before randomization
  • Has not adequately recovered from major surgery or has ongoing surgical complications
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
  • 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 a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
  • For exclusion criteria: The main exclusion criteria include but are not limited to the following:
  • Has any of the following: a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen

Where in Netherlands

Also in 18 other countries, 110 sites

  • Haga Hospital's-Gravenhage, NetherlandsTaking people
  • Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, NetherlandsTaking people
  • Academisch Ziekenhuis MaastrichtMaastricht, NetherlandsTaking people
  • Sint Franciscus Vlietland Groep StichtingSchiedam, NetherlandsTaking people

About the trial

What the trial wants to find out

Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC).

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Belzutifan + ZanzalintinibTreatment being tested

    Participants will receive 120 mg belzutifan orally and 60 mg zanzalintinib once daily for approximately 24 months.

    Treatment: Belzutifan and Zanzalintinib

  • Belzutifan + PlaceboExisting treatment, for comparison

    Participants will receive 120 mg belzutifan orally and zanzalintinib-matching placebo once daily for approximately 24 months.

    Treatment: Belzutifan and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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)
Plain-language title
Belzutifan with zanzalintinib or placebo in advanced kidney cancer after earlier treatmentsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
10 November 2026