Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
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
Study ID: NCT05468697
Conditions
Study Description
Brief 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. Part 1 will establish the safety of belzutifan plus palbociclib and determine a recommended dosage of palbociclib for the combination therapy by ascending dose escalation. Part 2 will evaluate the efficacy and safety of belzutifan plus palbociclib at the dosage level determined in Part 1.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Georgetown University Medical Center ( Site 1002), Washington, District of Columbia, 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
Rambam Health Care Campus-Oncology ( Site 3000), Haifa, , Israel
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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