Merck, MK-6482-033, Ph 3, Rand/open-label, RCC, Belzutifan+Zanzalintinib vz Cabozantinib

What is the Purpose of this Study?

Primary Objective: To compare belzutifan + zanzalintinib to cabozantinib with respect to PFS per RECIST 1.1 as assessed by BICR To compare belzutifan + zanzalintinib to cabozantinib with respect to OS Secondary Objectives: To compare belzutifan + zanzalintinib to cabozantinib with respect to ORR per RECIST 1.1 as assessed by BICR To evaluate the DOR of both treatment arms per RECIST 1.1 as assessed by BICR To evaluate the safety and tolerability of belzutifan + zanzalintinib To evaluate belzutifan + zanzalintinib and cabozantinib with respect to mean change from baseline in HRQoL and disease-related symptoms using the EORTC-QLQ-C30 and the FKSI-DRS To evaluate belzutifan + zanzalintinib and cabozantinib with respect to TTD in HRQoL and disease-related symptoms using the EORTC-QLQ-C30 and FKSI-DRS

Eligibility

* 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)

Inclusion Criteria:

* 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:

* 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

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Where can I participate?

CS Cancer at Beverly Hills : Maria Tarallo
CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo

More about this Clinical Trial

What is the full name of this clinical trial?

MK-6482-033: 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

Study Details

Disease Type/Condition

Kidney

Principal Investigator

Posadas, Edwin

Co-Investigators

David Hoffman, Emily Kaymen, James Hu, Jeremy Lorber, Jun Gong, Kevin Scher

Age Group

Adult

Phase

III

IRB Number

STUDY00004701

ClinicalTrials.gov ID

NCT07227402

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Maria Tarallo

Email

Maria.Tarallo@cshs.org