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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 Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)
Active Not RecruitingPhase 1, Phase 2
Sponsor: Merck Sharp & Dohme LLC
Conditions: Renal Cell Carcinoma
Interventions: Belzutifan, Palbociclib
Countries: United States, Australia, Israel
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations (13)
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Salt Lake City, Utah, United States
- Macquarie University, New South Wales, Australia
- Westmead, New South Wales, Australia
- Frankston, Victoria, Australia
- Nedlands, Western Australia, Australia
- Afula, Israel
- Haifa, Israel
- Jerusalem, Israel
- Petah Tikva, Israel
- Tel Aviv, Israel