NCT05468697

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 Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-10
• Primary completion: 2026-07-21
• Completion: 2026-07-21
• First posted: 2022-07-21
• Last updated: 2026-01-23

Locations

13 sites across 3 countries: United States, Australia, Israel

Regulatory

• FDA-regulated drug study