A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

Study Identifier:
MK-6482-043
CT.gov Identifier:
NCT07405164
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-524160-38-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Von Hippel-Lindau Disease
  • Solid Tumor
  • Renal
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: ACTIVE COMPARATOR: Cohort C: Non-Belzutifan Therapy
    • Read More
  • Drug: 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.
  • Drug: Drug: Cabozantinib
  • Drug: Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Drug: Drug: Everolimus
  • Drug: Everolimus is administered orally at 10 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Drug: Drug: Lenvatinib
  • Drug: Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Drug: EXPERIMENTAL: Cohort A: Belzutifan Monotherapy
  • Drug: 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.
  • Drug: Drug: Belzutifan
  • Drug: Belzutifan is administered orally at 120 mg once daily (qd) OR 160 mg twice daily (bid) OR 160 mg three times daily (tid) OR 200 mg qd OR 240 mg qd until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Drug: Other Names: MK-6482, PT2977, WELIREG
  • Drug: EXPERIMENTAL: Cohort B: Belzutifan Combination Therapy
  • Drug: 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.
  • Drug: Drug: Nivolumab
  • Drug: Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Drug: Drug: Palbociclib
  • Drug: Palbociclib is administered orally at 75 mg qd OR 100 mg qd OR 125 mg qd for 21 consecutive days; 7 days off, until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Von Hippel-Lindau Disease
    Solid Tumor
    Renal