Clinical Research Directory
Browse clinical research sites, groups, and studies.
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)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-08-10
Completion Date
2026-07-21
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
Belzutifan
40 mg tablet administered orally at a dose of 120 mg.
Palbociclib
75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
Locations (13)
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