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HIF-2α Inhibitor

Belzutifan for Advanced Cancers

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male participants are eligible to participate if they agree to specific conditions

Cohort A1: Pheochromocytoma/Paraganglioma (PPGL) - Has documented histopathological diagnosis of pheochromocytoma or paraganglioma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5.5 years

Awards & highlights

Study Summary

This trial is testing a new drug, Belzutifan, for people with certain types of tumors. The goal is to see if it shrinks the tumors.

Who is the study for?

This trial is for adults with certain advanced cancers like pheochromocytoma, paraganglioma, pancreatic neuroendocrine tumors, VHL-associated tumors, GIST or solid tumors with HIF-2α alterations. Participants must have a specific diagnosis for each cohort, controlled blood pressure, good organ function and not be pregnant or breastfeeding. They should not have other treatments recently and no major health issues that could affect the study.Check my eligibility

What is being tested?

The trial tests belzutifan's effectiveness and safety on its own in treating various advanced cancers related to HIF-2α genetic changes. The main goal is to see how well the cancer responds to belzutifan according to standard response criteria reviewed by independent experts.See study design

What are the potential side effects?

Possible side effects of belzutifan may include fatigue, nausea, anemia (low red blood cell count), hypoxia (low oxygen levels), high blood pressure and liver problems among others. Each person might experience these differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a male and agree to follow specific study conditions.

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I have been diagnosed with pheochromocytoma or paraganglioma.

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I am not pregnant or breastfeeding and meet the specific conditions.

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My advanced cancer cannot be removed by surgery or cured with treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I can provide a sample of my tumor for testing.

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My pancreatic neuroendocrine tumor cannot be treated with surgery, radiation, or other local therapies aimed at cure.

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My PPGL cannot be removed by surgery or cured with treatment.

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My blood pressure is under control and I have PPGL.

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My organs are functioning well.

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My pancreatic cancer has worsened after at least one treatment.

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I have a confirmed diagnosis of GIST based on tissue analysis.

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My pancreatic tumor is confirmed to be a low or intermediate grade neuroendocrine tumor.

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I have VHL disease with at least one tumor that can be measured.

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I have been diagnosed with VHL disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)

Secondary outcome measures

Disease Control Rate (DCR) as Assessed by BICR

Duration of Response (DOR) as Assessed by BICR

Number of Participants Discontinuing Study Drug due to an AE

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: BelzutifanExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belzutifan

2018

Completed Phase 1

~40

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,500 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,249 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,158 Total Patients Enrolled

Media Library

Belzutifan (HIF-2α Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04924075 — Phase 2

Pancreatic Neuroendocrine Tumors Research Study Groups: Belzutifan

Pancreatic Neuroendocrine Tumors Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT04924075 — Phase 2

Belzutifan (HIF-2α Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04924075 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being signed up for this experiment?

"That is correct, the trial is currently looking for participants. The listing on clinicaltrials.gov shows that the trial was posted on 8/12/2021 and edited on 11/9/2022. 13 different sites are being used to recruit the 232 patients needed for this study."

Answered by AI

Are there other examples where Belzutifan has been used in medical research?

"There are currently 16 clinical trials studying Belzutifan's efficacy with 3 of them being in Phase 3. Although a majority of the research is based in Cardiff, Wales, there are 850 different locations conducting these studies."

Answered by AI

Does this research break new ground?

"There are 16 ongoing clinical trials for Belzutifan in 370 cities and 44 countries. The earliest trial was held in 2016 and involved 120 patients. The study completed its Phase 1 drug approval stage and 1 additional study has been conducted since then."

Answered by AI

Could you tell me how many different facilities are testing this new treatment?

"Currently, University of Texas MD Anderson Cancer Center (Site 0112), Icahn School of Medicine at Mount Sinai (Site 0123), Penn Medicine: University of Pennsylvania Health System-Heme/Onc (Site 0127) are enrolling patients for this study. There are also 13 other sites across the country participating in this trial."

Answered by AI

What has Belzutifan been traditionally used to treat?

"Belzutifan has demonstrated efficacy in the treatment of malignant neoplasms, anemia, sickle cell, and von hippel lindau disease."

Answered by AI

Has Belzutifan been cleared by the FDA?

"Since there is only preliminary data indicating that Belzutifan is safe for human use, it received a score of 2."

Answered by AI

Are investigators still looking for volunteers for this research project?

"This study is still looking for participants, according to the most recent information on clinicaltrials.gov. The trial was first posted on 8/12/2021 and was last edited on 11/9/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04924075.

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