Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04924075
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belzutifan — DRUG
    Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.

Study Details

This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Key Dates

Start date
Aug 12, 2021
Status verified
Jun 2026
Primary completion
Dec 27, 2029
Completion
Dec 27, 2029

Study Design

Enrollment
355 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Belzutifan
    Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.

Primary Outcome Measure

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 5.5 years ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center ( Site 0110)Los AngelesCalifornia90048
Study Coordinator
310-967-2781
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)ChicagoIllinois60611
Study Coordinator
312-695-1310
Northwestern Medicine Cancer Center - Warrenville ( Site 0134)WarrenvilleIllinois60555
Study Coordinator
312-695-1310
University of Iowa ( Site 0104)Iowa CityIowa52242
Study Coordinator
319-356-2148
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)BaltimoreMaryland21287
Study Coordinator
410-502-5140
National Institutes of Health ( Site 0125)BethesdaMaryland20892
Study Coordinator
240-858-3851
Massachusetts General Hospital ( Site 0111)BostonMassachusetts02114
Study Coordinator
617-724-4000
University of Michigan ( Site 0126)Ann ArborMichigan48109
Study Coordinator
734-647-8902
Washington University-Internal Medicine/Oncology ( Site 0124)St LouisMissouri63110-
Icahn School of Medicine at Mount Sinai ( Site 0123)New YorkNew York10029-
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)PhiladelphiaPennsylvania19104-
SCRI Oncology Partners ( Site 7000)NashvilleTennessee37203
Study Coordinator
615-329-7274
Vanderbilt University Medical Center ( Site 0107)NashvilleTennessee37232
Study Coordinator
800-811-8480
University of Texas MD Anderson Cancer Center ( Site 0112)HoustonTexas77030
Study Coordinator
713-792-2841

Find similar trials in Los Angeles, CA

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Cedars-Sinai Medical Center· Los Angeles, CANorthwestern University - Robert H. Lurie Comprehensive Cancer Center· Chicago, ILNorthwestern Medicine Cancer Center - Warrenville· Warrenville, ILUniversity of Iowa· Iowa City, IAJohns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics· Baltimore, MDNational Institutes of Health· Bethesda, MD

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