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ACTIVE NOT RECRUITING
NCT05468697
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Belzutifan

40 mg tablet administered orally at a dose of 120 mg.

DRUG

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