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)
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Renal Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05468697
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 60
- Starts
- 2022-08-10
- Expected to finish
- 2026-09-22
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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