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)

StatusRecruiting

PhasePhase 2

SponsorMerck Sharp & Dohme LLC

Started2021-08-12

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary completion moved at least 34 months later Dec 27, 2029 → Nov 18, 2032

See other at-risk trials from Merck (MSD)

Amendment history

The 50 most recent of 134 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-01

Study Status, Contacts/Locations v133

Primary completion pushed: 2029-12-27 → 2032-11-18

Completion pushed: 2029-12-27 → 2032-11-18

Study sitesdetails revised at 1 of 84 sites

2026-07-31

Study Status, Contacts/Locations v132

Study sitesdetails revised at 1 of 84 sites

2026-07-17

Study Status, Contacts/Locations v131

Study sites84 entries, revised

~~Azienda~~Centro ~~Ospedaliera~~Ricerche ~~Universitaria~~Cliniche ~~Integrata~~di Verona ~~- Ospedale Borgo Roma~~ ( Site 0703)

2026-07-06

Study Status, Contacts/Locations v130

Study sitesdetails revised at 1 of 84 sites

2026-06-24

Study Status, Contacts/Locations v129

Study sitesdetails revised at 1 of 84 sites

2026-06-04

Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v128

Enrollment increased: 322 → 355 participants

Primary completion pushed: 2029-06-04 → 2029-12-27

Completion pushed: 2029-06-04 → 2029-12-27

Eligibility criteriarevised

[...] 2 alpha subunit (HIF-2α) related genetic alterations Cohort BIB1: VHL Disease-associated tumors: Have a diagnosis of VHL dis [...]

Secondary endpoints8 entries, revised

Number of Participants ~~Experiencing~~Who Experience an Adverse ~~Events~~Event (~~AEs~~AE) Number of Participants ~~Discontinuing~~Who Discontinue Study ~~Drug~~Treatment ~~due~~Due to an AE

Study sitesdetails revised at 2 of 84 sites

2026-05-27

Study Status, Contacts/Locations v127

Study sitesdetails revised at 2 of 84 sites

2026-05-08

Study Status, Contacts/Locations v126

Study sitesdetails revised at 5 of 84 sites

2026-05-01

Study Status, Contacts/Locations v125

Study sitesdetails revised at 4 of 84 sites

2026-04-22

Study Status, Contacts/Locations v124

Study sitesdetails revised at 2 of 84 sites

2026-04-09

Study Status, Contacts/Locations v123

Study sitescontacts updated at 1 of 84 sites

2026-04-01

Study Status, Contacts/Locations v122

Study sitescontacts updated at 1 of 84 sites

2026-02-20

Study Status, Contacts/Locations v121

Study sitesdetails revised at 1 of 84 sites

2026-01-02

Study Status, Contacts/Locations v120

Study sitesdetails revised at 1 of 84 sites

2025-11-20

Study Status, Contacts/Locations v119

Study sites83→84

2025-11-12

Study Status, Contacts/Locations v118

Study sitesdetails revised at 1 of 83 sites

2025-11-10

Study Status, Contacts/Locations v117

Study sitesdetails revised at 3 of 83 sites

2025-10-28

Study Status, Contacts/Locations v116

Study sitesdetails revised at 2 of 83 sites

2025-10-27

Study Status, References v115

Publicationsdetails revised at 1 of 1 entry

2025-10-23

Study Status, Contacts/Locations v114

Study sitesdetails revised at 2 of 83 sites

2025-10-10

Study Status, Contacts/Locations v113

Study sitesdetails revised at 1 of 83 sites

2025-09-24

Study Status, Contacts/Locations v112

Study sitesdetails revised at 1 of 83 sites

2025-09-17

Study Status, Contacts/Locations v111

Study sites82→83

2025-09-08

Study Status, Contacts/Locations v110

Study sitesdetails revised at 2 of 82 sites

2025-08-12

Study Status, Contacts/Locations v109

Study sites81→82

2025-07-30

Study Status, Contacts/Locations v108

Study sites80→81

2025-07-23

Study Status, Contacts/Locations v107

Study sites77→80

2025-07-16

Study Status, Contacts/Locations v106

Study sitescontacts updated at 1 of 77 sites

2025-07-03

Study Status, Contacts/Locations v105

Study sites76→77

2025-06-27

Study Status, Contacts/Locations v104

Study sites79→76

2025-05-23

Study Identification, Study Status, Contacts/Locations v103

Study sites79 entries, revised

Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108) Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501) Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503) Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700) Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Site 0805)

2025-05-02

Study Status, Contacts/Locations v102

Study sitescontacts updated at 1 of 79 sites

2025-04-24

Study Status, Contacts/Locations v101

Study sites77→79

2025-04-17

Study Status, Contacts/Locations v100

Study sitescontacts updated at 1 of 77 sites

2025-04-09

Study Status, Study Description, Eligibility, Contacts/Locations v99

Eligibility criteria-12,487 characters

Inclusion Criteria: Cohort A1: Pheochromocytoma/Paraganglioma (PPGL) - Has documented histopathological diagnosis (local report) of pheochromocytoma or paraganglioma Note: Participants are allowed to receive therapy in first line where a satisfactory treatment option does not exist and if participan [...] The main inclusion criteria include but are not limited to the following: Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1) Diagnosis of one of the following: Advanced/metastatic pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumors (pNE [...] [...]

Study sitescontacts updated at 5 of 77 sites

2025-03-26

Study Status, Contacts/Locations v98

Study sitesdetails revised at 1 of 77 sites

2025-03-21

Study Status, Contacts/Locations v97

Study sitesdetails revised at 3 of 77 sites

2025-03-13

Study Status, Contacts/Locations v96

Study sitesdetails revised at 2 of 77 sites

2025-03-06

Study Status, Contacts/Locations v95

Study sitesdetails revised at 1 of 77 sites

2025-02-26

Study Identification, Study Status, Contacts/Locations, IPDSharing v94

Study sites76→77

2025-02-07

Study Status, Contacts/Locations v93

Study sites73→76

2024-12-26

Study Status, Contacts/Locations v92

Study sites72→73

2024-12-12

Study Status, Contacts/Locations v91

Primary completion date2027-02-26→2029-06-04

Completion date2027-02-26→2029-06-04

Study sites71→72

2024-11-22

Study Status, References v90

Re-verified, no change to tracked fields

2024-11-13

Study Status, Contacts/Locations v89

Study sitesdetails revised at 1 of 71 sites

2024-11-06

Study Status, Contacts/Locations v88

Study sites70→71

2024-10-01

Study Status, Contacts/Locations v87

Study sitesdetails revised at 2 of 70 sites

2024-09-25

Study Status, Contacts/Locations v86

Study sitesdetails revised at 2 of 70 sites

2024-08-21

Study Identification, Study Status, Contacts/Locations v85

Study sitesdetails revised at 1 of 70 sites

2024-08-14

Study Status, Contacts/Locations v84

Study sitesdetails revised at 1 of 70 sites

Merck (MSD)

401 trials monitored

See 24 trials at risk

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).

Trial Details

NCT Number	NCT04924075
Lead Sponsor	Merck Sharp & Dohme LLC
Conditions	Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, Von Hippel-Lindau Disease, Advanced Gastrointestinal Stromal Tumor, HIF-2α Mutated Cancers
Enrollment	355 participants
Start Date	2021-08-12
Primary Completion	2032-11-18 (estimated)
Study Completion	2032-11-18 (estimated)
Updated on ClinicalTrials.gov	2026-09-25