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

RecruitingPhase 3Ages 18 Years - anyAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 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 Exclusion Criteria: 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 * 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 โ‰ค50% 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
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What it tests

  • Belzutifan
  • Zanzalintinib
  • Placebo
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Where

106 sites
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)
Marietta, United States
University of Louisville, James Graham Brown Cancer Center ( Site 0133)
Louisville, United States
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0104)
Louisville, United States
Beth Israel Deaconess Medical Center ( Site 0139)
Boston, United States
Dana Farber Cancer Institute ( Site 0135)
Boston, United States
The Cancer and Hematology Centers ( Site 0123)
Grand Rapids, United States
Washington University School of Medicine ( Site 0114)
St Louis, United States
Atlantic Health System Morristown Medical Center ( Site 0109)
Morristown, United States

โ€ฆand 98 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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