Recruiting
Phase 3

Belzutifan

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07405164

Conditions

Von Hippel-Lindau Disease

Malignant Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Belzutifan

Nivolumab

Lenvatinib

Cabozantinib

Study Details

Brief summary:

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.

Conditions

Von Hippel-Lindau Disease

Malignant Neoplasms

Study ID

NCT07405164

Start date

Mar 23, 2026

Status verified date

Sep, 2026

Completion date

Jan 14, 2034

Anticipated

Primary completion date

Jan 14, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Participants with advanced solid tumors or von Hippel-Lindau-related neoplasms who are participating in belzutifan-containing studies and on active treatment in a belzutifan parent study.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable.
  • 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.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A: Belzutifan Monotherapy

Participants on active treatment assigned to belzutifan monotherapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

experimental: Cohort B: Belzutifan Combination Therapy

Participants on active treatment assigned to a belzutifan combination therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

active comparator: Cohort C: Non-Belzutifan Therapy

Participants on active treatment assigned to a non-belzutifan therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

Interventions

Belzutifan

Belzutifan is administered orally at 120 mg once daily (qd) OR 200 mg qd until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

Nivolumab

Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

Lenvatinib

Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

Cabozantinib

Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

Primary outcome measure

  • Cohort A and Cohort B: Overall Survival (OS) [ Time Frame: Up to approximately 7 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Beth Israel Deaconess Medical Center ( Site 0107)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-667-7000

Dana-Farber Cancer Institute ( Site 0105)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-632-3466

Karmanos Cancer Center ( Site 0108)

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Study Coordinator

800-527-6266

Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 0100)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-360-0737

SCRI Oncology Partners ( Site 7000)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-329-7274

START San Antonio ( Site 0104)

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Study Coordinator

210-593-5265

Fred Hutchinson Cancer Center ( Site 0106)

Recruiting

Seattle, Washington, United States, 98109

Contacts

Study Coordinator

206-606-7341

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.