Study

Overview

Official Title: A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants with Advanced RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib. The goal of this study is to learn if: People who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

904

Study Start Date:

December 2025

Estimated Study Completion Date:

February 2032

Estimated Primary Completion Date:

February 2032

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

Inclusion Criteria:

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

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

Exclusion Criteria:

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

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

Locations

No Contacts or Locations in US/Canada Provided

Results

No Study Results Posted

Study Detail

A clinical study of belzutifan and zanzalintinib in people with recurrent kidney cancer following adjuvant therapy (MK-6482-033)

Overview

Eligibility

CRITERIA

Locations

Results