A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)
NCT ID: NCT05468697
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2022-08-10
2026-07-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)
NCT04489771
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
NCT04586231
A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
NCT05239728
A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK-6482-018)
NCT04846920
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
NCT03634540
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Beltuzifan 120 mg + Palbociclib 75 mg
Participants receive beltuzifan 120 mg orally once per day (QD) and palbociclib 75 mg orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation.
Belzutifan
40 mg tablet administered orally at a dose of 120 mg.
Palbociclib
75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
Beltuzifan 120 mg + Palbociclib 100 mg
Participants receive beltuzifan 120 mg orally QD and palbociclib 100 mg orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation.
Belzutifan
40 mg tablet administered orally at a dose of 120 mg.
Palbociclib
75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
Beltuzifan 120 mg + Palbociclib 125 mg
Participants receive beltuzifan 120 mg orally QD and palbociclib 125 mg orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation.
Belzutifan
40 mg tablet administered orally at a dose of 120 mg.
Palbociclib
75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Belzutifan
40 mg tablet administered orally at a dose of 120 mg.
Palbociclib
75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has had disease progression on or after having received at least 2 systemic treatments for unresectable Stage IV RCC with prior anti-programmed cell death 1 ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
* Has measurable disease per RECIST 1.1 as assessed by the investigator and verified by blinded independent central review (BICR)
* Has recovered from all AEs due to previous therapies
Exclusion Criteria
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has clinically significant cardiac disease
* Has moderate to severe hepatic impairment
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a history of hepatitis B (HBV) or known active hepatitis C (HCV) infection
* Has received prior treatment of belzutifan or palbociclib
* Has received prior radiotherapy ≤2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids
* Has had major surgery ≤3 weeks prior to first dose of study intervention
* Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin \[EPO\]) ≤28 days prior to the first dose of study intervention
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Georgetown University Medical Center ( Site 1002)
Washington D.C., District of Columbia, United States
University of Chicago Medical Center ( Site 1007)
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001)
Boston, Massachusetts, United States
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004)
Salt Lake City, Utah, United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 2001)
Macquarie University, New South Wales, Australia
Westmead Hospital ( Site 2006)
Westmead, New South Wales, Australia
Frankston Hospital-Oncology and Haematology ( Site 2005)
Frankston, Victoria, Australia
One Clinical Research ( Site 2008)
Nedlands, Western Australia, Australia
Emek Medical Center-oncology ( Site 3003)
Afula, , Israel
Rambam Health Care Campus-Oncology ( Site 3000)
Haifa, , Israel
Shaare Zedek Medical Center-Oncology ( Site 3002)
Jerusalem, , Israel
Rabin Medical Center-Oncology ( Site 3004)
Petah Tikva, , Israel
Sourasky Medical Center ( Site 3005)
Tel Aviv, , Israel
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Meiman D, Skaar TC, Shugg T, Quinney SK. Physiologically Based Pharmacokinetic Model to Assess the Drug-Drug-Gene Interaction Potential of Belzutifan in Combination With Cyclin-Dependent Kinase 4/6 Inhibitors. JCO Precis Oncol. 2025 Jul;9:e2500153. doi: 10.1200/PO-25-00153. Epub 2025 Jul 25.
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK-6482-024
Identifier Type: OTHER
Identifier Source: secondary_id
LITESPARK-024
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504963-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1290-4845
Identifier Type: REGISTRY
Identifier Source: secondary_id
6482-024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.