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
- Diseases
- Kidney cancer
- 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
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Frankston Hospital-Oncology and Haematology ( Site 2005) Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 2001) Coordinator of this site? Confirm its status | Macquarie University | Australia | Unknown status |
| One Clinical Research ( Site 2008) Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Westmead Hospital ( Site 2006) Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Emek Medical Center-oncology ( Site 3003) Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| Rambam Health Care Campus-Oncology ( Site 3000) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center-Oncology ( Site 3002) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center-Oncology ( Site 3004) Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sourasky Medical Center ( Site 3005) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Chicago Medical Center ( Site 1007) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004) Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Georgetown University Medical Center ( Site 1002) Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.