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)

Last updated: May 2, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Renal Cell Carcinoma

Cancer/tumors

Carcinoma

Treatment

Belzutifan

Palbociclib

Clinical Study ID

NCT05468697
6482-024
LITESPARK-024
MK-6482-024
U1111-1290-4845
2023-504963-17
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a histologically confirmed diagnosis of unresectable Stage IV (per AmericanJoint Committee on Cancer [AJCC], 8th Edition) RCC with clear-cell component

  • Has had disease progression on or after having received at least 2 systemictreatments for unresectable Stage IV RCC with prior anti-programmed cell death 1ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinaseinhibitor (VEGF-TKI) in sequence or in combination

  • Has measurable disease per RECIST 1.1 as assessed by the investigator and verifiedby blinded independent central review (BICR)

  • Has recovered from all AEs due to previous therapies

Exclusion

Exclusion Criteria:

  • Has hypoxia, requires intermittent supplemental oxygen, or requires chronicsupplemental oxygen

  • Has a known additional malignancy that is progressing or has required activetreatment 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 notrequire 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 recombinanterythropoietin [EPO]) ≤28 days prior to the first dose of study intervention

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: Belzutifan
Phase: 1/2
Study Start date:
August 10, 2022
Estimated Completion Date:
September 16, 2028

Connect with a study center

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 2001)

    Macquarie University, New South Wales 2109
    Australia

    Active - Recruiting

  • Westmead Hospital ( Site 2006)

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Westmead Hospital-Department of Medical Oncology ( Site 2006)

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Frankston Hospital-Oncology and Haematology ( Site 2005)

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • One Clinical Research ( Site 2008)

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Emek Medical Center-oncology ( Site 3003)

    Afula, 1834111
    Israel

    Active - Recruiting

  • Rambam Health Care Campus-Oncology ( Site 3000)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center-Oncology ( Site 3002)

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Rabin Medical Center-Oncology ( Site 3004)

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Sourasky Medical Center ( Site 3005)

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Georgetown University Medical Center ( Site 1002)

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • University of Chicago Medical Center ( Site 1007)

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001)

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004)

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

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