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Clinical Trials List

Protocol NumberMK-6482-033
NCT Number(ClinicalTrials.gov Identfier)NCT07227402
Active

2025-11-01 - 2034-12-31

Phase III

Not yet recruiting1

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)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    MERCK SHARP & DOHME (I.A.) LLC. TAIWAN BRANCH (U.S.A.)

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/11

Investigators and Locations

Principal Investigator Yi-Hsiu Huang Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

Principal Investigator Chi-Ping Huang Division of Urology
China Medical University Hospital

Co-Principal Investigator

Principal Investigator Jian-Ri Li Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

Principal Investigator Kai-Jie Yu
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Renal Cell Carcinoma

Objectives

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.

Test Drug

Belzutifan (MK-6482)
Zanzalintinib (XL092)

Active Ingredient

Belzutifan
Zanzalintinib

Dosage Form

Tablet
Tablet

Dosage

40 mg
20 mg、40 mg、60 mg

Endpoints

Progression Free Survival (PFS) PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD will be assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Overall Survival (OS) OS is defined as the time from randomization to death due to any cause.

Inclution 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
Has pharmacologically uncompensated, symptomatic hypothyroidism
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    904 participants

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