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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 - Beltuzifan 120 mg + Palbociclib 75 mg 		Participants receive beltuzifan 120 mg orally once per day (QD) and palbociclib 75 mg orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation.
  • Drug: Belzutifan
    40 mg tablet administered orally at a dose of 120 mg.
    Other names:
    • WELIREG™
    • MK-6482
    • PT2977
  • Drug: Palbociclib
    75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
    Other names:
    • IBRANCE®
    • PD 0332991
Experimental
Part 1 - Beltuzifan 120 mg + Palbociclib 100 mg 		Participants receive beltuzifan 120 mg orally QD and palbociclib 100 mg orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation.
  • Drug: Belzutifan
    40 mg tablet administered orally at a dose of 120 mg.
    Other names:
    • WELIREG™
    • MK-6482
    • PT2977
  • Drug: Palbociclib
    75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
    Other names:
    • IBRANCE®
    • PD 0332991
Experimental
Part 1 - Beltuzifan 120 mg + Palbociclib 125 mg 		Participants receive beltuzifan 120 mg orally QD and palbociclib 125 mg orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation.
  • Drug: Belzutifan
    40 mg tablet administered orally at a dose of 120 mg.
    Other names:
    • WELIREG™
    • MK-6482
    • PT2977
  • Drug: Palbociclib
    75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
    Other names:
    • IBRANCE®
    • PD 0332991
Experimental
Part 2 - Beltuzifan 120 mg + Palbociclib 		Participants receive beltuzifan 120 mg orally QD and palbociclib orally QD in a 28-day schedule (21 days on followed by 7 days off), until progressive disease or discontinuation. Palbociclib will be administered at a dosage level determined in Part 1.
  • Drug: Belzutifan
    40 mg tablet administered orally at a dose of 120 mg.
    Other names:
    • WELIREG™
    • MK-6482
    • PT2977
  • Drug: Palbociclib
    75, 100, or 125 mg tablet administered orally according to randomized dose for 21 days consecutive days followed by 7 days off.
    Other names:
    • IBRANCE®
    • PD 0332991
Experimental
Part 2 - Beltuzifan 120 mg 		Participants receive beltuzifan 120 mg orally QD until progressive disease or discontinuation.
  • Drug: Belzutifan
    40 mg tablet administered orally at a dose of 120 mg.
    Other names:
    • WELIREG™
    • MK-6482
    • PT2977

Recruiting Locations

Georgetown University Medical Center ( Site 1002)
Washington, District of Columbia 20007
Contact:
Study Coordinator
617-797-5460

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.