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NCT05468697Active, not recruitingPhase 1/2

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)

A Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of belzutifan monotherapy and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced disease progression on or after receiving prior therapy. The study will establish the safety of belzutifan plus palbociclib and determine a recommended dosage of palbociclib for the combination therapy by ascending dose escalation.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
18 Jul 2022
Start date
10 Aug 2022
Primary completion date
22 Dec 2026
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05468697
EU CT number
2023-504963-17-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 60
  • From 10 Aug 2022 to the primary completion date, 22 Dec 2026
  • 13 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • 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

Other

  • Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis

Who the study is looking for

  • Has a histologically confirmed diagnosis of unresectable Stage IV (per American Joint Committee on Cancer \[AJCC\], 8th Edition) RCC with clear-cell component
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Frankston Hospital-Oncology and Haematology ( Site 2005)
Coordinator of this site? Confirm its status
FrankstonAustraliaUnknown status
Macquarie University-MQ Health Clinical Trials Unit ( Site 2001)
Coordinator of this site? Confirm its status
Macquarie UniversityAustraliaUnknown status
One Clinical Research ( Site 2008)
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Westmead Hospital ( Site 2006)
Coordinator of this site? Confirm its status
WestmeadAustraliaUnknown status
Emek Medical Center-oncology ( Site 3003)
Coordinator of this site? Confirm its status
AfulaIsraelUnknown status
Rambam Health Care Campus-Oncology ( Site 3000)
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Shaare Zedek Medical Center-Oncology ( Site 3002)
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Rabin Medical Center-Oncology ( Site 3004)
Coordinator of this site? Confirm its status
Petah TikvaIsraelUnknown status
Sourasky Medical Center ( Site 3005)
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001)
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
University of Chicago Medical Center ( Site 1007)
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004)
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
Georgetown University Medical Center ( Site 1002)
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.