Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Belzutifan
DrugBelzutifan 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
DrugNivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Lenvatinib
DrugLenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Cabozantinib
DrugCabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Treatment groups
450 Participants
are divided into 3 treatment groupsGroup A: Cohort A: Belzutifan MonotherapyExperimental treatment 1 intervention
Group B: Cohort B: Belzutifan Combination TherapyExperimental treatment 4 interventions
Group C: Cohort C: Non-Belzutifan TherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Cohort A and Cohort B: Overall Survival (OS)
Overall survival is defined as the time from randomization or the first dose of any study intervention in the parent study to death due to any cause.
Time frame
Up to approximately 7 yearsSecondary outcomes
1
Number of Participants Who Experience One or More Adverse Events (AE)
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time frame
Up to approximately 2 years2
Number of Participants Who Discontinued Study Intervention Due to an AE
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov