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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6482-024 | Other Identifier | MSD | |
| LITESPARK-024 | Other Identifier | MSD | |
| 2023-504963-17-00 | Registry Identifier | EU CT | |
| U1111-1290-4845 | Registry Identifier | UTN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beltuzifan 120 mg + Palbociclib 75 mg | Experimental | 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. |
|
| Beltuzifan 120 mg + Palbociclib 100 mg | Experimental | 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. |
|
| Beltuzifan 120 mg + Palbociclib 125 mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belzutifan | Drug | 40 mg tablet administered orally at a dose of 120 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least One Dose-limiting Toxicity (DLT) | A DLT consists of one or more of the following toxicities: Grade (Gr) 3 or 4 hypoxia or dyspnea; Gr 3 or 4 nausea, vomiting, or diarrhea if persistent for >48 hours despite therapy; Gr 3 or 4 cardiovascular, vascular, or thrombotic events; Nonhematologic AE ≥Gr 3 in severity with exceptions; Gr 3 rash that does not resolve within 2 weeks; Gr 3 nonhematologic toxicity if persisting despite optimal medical treatment; Gr 3 or 4 hematologic toxicities; Gr 3 or 4 febrile neutropenia; Gr 3 or 4 nonhematologic laboratory value; Any aspartate aminotransferase or alanine aminotransferase >8x the upper limit of normal (ULN) or 5 to 8x ULN persisting for >2 weeks; >2 weeks delay in dosing due to intervention-related toxicity; Intervention-related toxicity causing intervention discontinuation in the first 28 days of dosing; Missing >20% of intervention doses due to drug-related AEs; Gr 5 toxicity. The number of participants who experience at least one DLT will be reported. | Up to approximately 28 days |
| Number of Participants Who Experience at Least One Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience at least one AE will be reported. | Up to approximately 4 years |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. The number of participants who discontinued from the study treatment due to an AE will be reported. | Up to approximately 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center ( Site 1002) | Washington D.C. | District of Columbia | 20007 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40712111 | Derived | 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. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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|
| Palbociclib | Drug | 75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off. |
|
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| University of Chicago Medical Center ( Site 1007) |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001) | Boston | Massachusetts | 02215 | United States |
| Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004) | Salt Lake City | Utah | 84112 | United States |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 2001) | Macquarie University | New South Wales | 2109 | Australia |
| Westmead Hospital ( Site 2006) | Westmead | New South Wales | 2145 | Australia |
| Frankston Hospital-Oncology and Haematology ( Site 2005) | Frankston | Victoria | 3199 | Australia |
| One Clinical Research ( Site 2008) | Nedlands | Western Australia | 6009 | Australia |
| Emek Medical Center-oncology ( Site 3003) | Afula | 1834111 | Israel |
| Rambam Health Care Campus-Oncology ( Site 3000) | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center-Oncology ( Site 3002) | Jerusalem | 9103102 | Israel |
| Rabin Medical Center-Oncology ( Site 3004) | Petah Tikva | 4941492 | Israel |
| Sourasky Medical Center ( Site 3005) | Tel Aviv | 6423906 | Israel |
| Plain Language Summary | View source |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000720612 | belzutifan |
| C500026 | palbociclib |
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