Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Von Hippel-Lindau Disease; Malignant Neoplasms

Treatments: Drug: Cabozantinib; Drug: Nivolumab; Drug: Belzutifan; Drug: Lenvatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07405164

2025-524160-38-00 (Registry Identifier)

6482-043

jRCT2061260008 (Registry Identifier)

U1111-1325-4582 (Registry Identifier)

MK-6482-043 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

Cohort A: Belzutifan Monotherapy

Experimental group

Description:

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.

Treatment:

Drug: Belzutifan

Cohort B: Belzutifan Combination Therapy

Experimental group

Description:

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.

Treatment:

Drug: Lenvatinib

Drug: Belzutifan

Drug: Nivolumab

Drug: Cabozantinib

Cohort C: Non-Belzutifan Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Lenvatinib

Drug: Cabozantinib