450 Participants NeededMy employer runs this trial

Belzutifan for Von Hippel-Lindau Syndrome

Recruiting at 9 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors:

* Advanced means the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery

* Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids

* VHL-related tumors are tumors caused by VHL disease. VHL disease is passed down from parents to children and people with VHL disease have a higher chance of getting certain types of cancer

Researchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

I have advanced solid tumors or VHL tumors and am on belzutifan treatment in a study.

Exclusion Criteria

Is currently on a dose interruption due to an Adverse Event (AE) in the parent study; once treatment has been resumed in the parent study, the participant is eligible to enroll.
Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable.

What Are the Treatments Tested in This Trial?

Interventions

  • Belzutifan

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Cohort B: Belzutifan Combination TherapyExperimental Treatment5 Interventions
Group II: Cohort A: Belzutifan MonotherapyExperimental Treatment1 Intervention
Group III: Cohort C: Non-Belzutifan TherapyActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University