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NCT04924075 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Pancreatic Neuroendocrine Tumor and Von Hippel-Lindau Disease, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 322
- Enrollment target
- 20
- Study locations
NCT04924075: Recruiting Phase 2 study of Pancreatic Neuroendocrine Tumor and Von Hippel-Lindau Disease, sponsored by Merck Sharp & Dohme.
NCT04924075 is a Phase 2 study of Pancreatic Neuroendocrine Tumor and Von Hippel-Lindau Disease that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 322 participants, above the 75-participant average among 7 other Pancreatic Neuroendocrine Tumor trials with a reported enrollment target (329% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04924075, a Phase 2 study of Pancreatic Neuroendocrine Tumor and Von Hippel-Lindau Disease, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 322 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
ORR is the percentage of participants with complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression) or death due
Conditions Studied
Interventions
- DRUG Belzutifan
Study Locations (20)
Illinois
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130) - Chicago
- Northwestern Medicine Cancer Center - Warrenville ( Site 0134) - Warrenville
Maryland
- Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108) - Baltimore
- National Institutes of Health ( Site 0125) - Bethesda
Tennessee
- SCRI Oncology Partners ( Site 7000) - Nashville
- Vanderbilt University Medical Center ( Site 0107) - Nashville
Region M. de Santiago
- FALP ( Site 2200) - Santiago
- Centro de Oncología de Precisión ( Site 2203) - Santiago
California
- Cedars-Sinai Medical Center ( Site 0110) - Los Angeles
Iowa
- University of Iowa ( Site 0104) - Iowa City
Massachusetts
- Massachusetts General Hospital ( Site 0111) - Boston
Michigan
- University of Michigan ( Site 0126) - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2021-08-12 |
| Est. Completion | 2029-06-04 |
| Phase | Phase 2 |
What NCT04924075 shows while recruiting
NCT04924075 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, above the 75-participant average among 7 other Pancreatic Neuroendocrine Tumor trials with a reported enrollment target (329% higher).
The record links to 5 conditions, with Pancreatic Neuroendocrine Tumor appearing as the primary indexed condition, and to 1 intervention - of which Belzutifan is the first listed.
NCT04924075 names 20 study sites across 16 states, led by Illinois, Maryland, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04924075 about?
NCT04924075 is a clinical study titled "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)". 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 GIS...
What is the current status of trial NCT04924075?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 322 participants. The study started on 2021-08-12. Estimated completion is 2029-06-04.
What conditions does trial NCT04924075 study?
This clinical trial studies the following conditions: Pancreatic Neuroendocrine Tumor, Von Hippel-Lindau Disease, Pheochromocytoma/Paraganglioma, Advanced Gastrointestinal Stromal Tumor, HIF-2α Mutated Cancers.
What interventions are being tested in trial NCT04924075?
The interventions under investigation include: Belzutifan (DRUG).
Who is sponsoring clinical trial NCT04924075?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04924075 being conducted?
This trial has 20 study locations across California, Illinois, Iowa, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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