Study

Overview

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

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.

Study Type:

Interventional

Study Phase:

Phase 1/Phase 2

Estimated Enrollment:

180

Study Start Date:

August 2022

Estimated Study Completion Date:

March 2027

Estimated Primary Completion Date:

March 2027

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

Inclusion Criteria:

Has a histologically confirmed diagnosis of unresectable Stage IV (per American Joint Committee on Cancer [AJCC], 8th Edition) RCC with clear-cell component
Has had disease progression on or after having received at least 2 systemic treatments for unresectable Stage IV RCC with prior anti-programmed cell death 1 ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
Has measurable disease per RECIST 1.1 as assessed by the investigator and verified by blinded independent central review (BICR)
Has recovered from all AEs due to previous therapies

Exclusion Criteria:

Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
Has clinically significant cardiac disease
Has moderate to severe hepatic impairment
Has a known history of human immunodeficiency virus (HIV) infection
Has a history of hepatitis B (HBV) or known active hepatitis C (HCV) infection
Has received prior treatment of belzutifan or palbociclib
Has received prior radiotherapy ≤2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids
Has had major surgery ≤3 weeks prior to first dose of study intervention
Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin [EPO]) ≤28 days prior to the first dose of study intervention

Locations

United States Toll Free Number 1-800-770-4674

Washington, District of Columbia, 20007
Boston, Massachusetts, 02215
Salt Lake City, Utah, 84112

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-6482-024-03

Study Detail

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)