Last updated 5 days ago
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
758 patients around the world
Available in Argentina
Merck Sharp & Dohme LLC
2Research sites
758Patients around the world
This study is for people with
Kidney cancer
Renal cell carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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 ≤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.
Sites
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Centro Privado de RMI Río Cuarto
Recruiting
StudyLITESPARK-034
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Renal cell carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07489495
