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Clinical Trials in France / NCT03401788
Active, not recruiting Phase 2

A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004)

NCT03401788 · tracked via the Priya Life Science France tracker
Sponsor
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase
Phase 2
Started
2018-05-02
Last updated
2026-04-13

Condition(s) studied

VHL - Von Hippel-Lindau SyndromeVHL Gene MutationVHL SyndromeVHL Gene InactivationVHL-Associated Renal Cell CarcinomaVHL-Associated Clear Cell Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

Belzutifan →

Belzutifan: 120 mg once daily (three 40 mg oral tablets once daily).

Study summary

This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration * Has at least 1 measurable solid RCC tumor and no RCC tumor that requires immediate surgical intervention. The diagnosis of RCC can be radiologic (histologic diagnosis not required). Participants may have VHL disease-associated tumors in other organ systems Exclusion Criteria: * Has received prior treatment with belzutifan or another HIF-2α inhibitor * Has had any systemic anti-cancer therapy (includes anti-vascular endothelial growth factor \[VEGF\] therapy or any systemic investigational anti-cancer agent) * Has an immediate need for surgical intervention for tumor treatment * Has evidence of metastatic disease on screening imaging

Primary outcome measure(s)

  • Objective Response Rate (ORR) in VHL Disease-Associated RCC Tumors — Up to approximately 4 years
    ORR is defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be assessed by independent review committee (ICR) for the primary analysis.

Trial sites (11)

FacilityCityRegionStatus
National Institutes of Health Clinical Center Bethesda Maryland
Massachusetts General Hospital Boston Massachusetts
University of Michigan Ann Arbor Michigan
University of Pennsylvania Medical Center Philadelphia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Vanderbilt Medical Center Nashville Tennessee
MD Anderson Cancer Center Houston Texas
Huntsman Cancer Institute Salt Lake City Utah
Aarhus University Hospital Aarhus Denmark
Hospital Georges Pompidou Paris France
Cambridge University Hospital Cambridge United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03401788 on ClinicalTrials.gov ↗ ← All trials in France