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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 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.

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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).

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

FieldValue
Enrollment Target 322 participants
Start Date 2021-08-12
Est. Completion 2029-06-04
Phase Phase 2

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT04924075

The ClinicalTrials.gov registry entry for NCT04924075 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 322 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 75-participant average among 7 other Pancreatic Neuroendocrine Tumor trials with a reported enrollment target (329% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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