Last updated 2 days ago
A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
904 patients around the world
Available in Argentina
Merck Sharp & Dohme LLC
6Research sites
904Patients 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
- Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee on Cancer (AJCC) (8th Edition).Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1/L1 therapy.Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1/L1 therapy.
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.Had 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 or has not adequately recovered from major surgery or has ongoing surgical complications.Has current pneumonitis/interstitial lung disease.Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization.Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation.Has a serious active nonhealing wound/ulcer/bone fracture.Has a requirement for hemodialysis or peritoneal dialysis.Has history of human immunodeficiency virus infection.Has hepatitis B or hepatitis C virus.Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Sites
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Recruiting
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Sanatorio Parque - Rosario
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
StudyLITESPARK-033
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Renal cell carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07227402
