Phase
Condition
Renal Cell Carcinoma
Carcinoma
Cancer/tumors
Treatment
Belzutifan
Palbociclib
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Macquarie University-MQ Health Clinical Trials Unit ( Site 2001)
Macquarie University, New South Wales 2109
AustraliaSite Not Available
Westmead Hospital ( Site 2006)
Westmead, New South Wales 2145
AustraliaSite Not Available
Westmead Hospital-Department of Medical Oncology ( Site 2006)
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Frankston Hospital-Oncology and Haematology ( Site 2005)
Frankston, Victoria 3199
AustraliaSite Not Available
One Clinical Research ( Site 2008)
Nedlands, Western Australia 6009
AustraliaSite Not Available
Emek Medical Center-oncology ( Site 3003)
Afula, 1834111
IsraelSite Not Available
Rambam Health Care Campus-Oncology ( Site 3000)
Haifa, 3109601
IsraelSite Not Available
Shaare Zedek Medical Center-Oncology ( Site 3002)
Jerusalem, 9103102
IsraelSite Not Available
Rabin Medical Center-Oncology ( Site 3004)
Petah Tikva, 4941492
IsraelSite Not Available
Sourasky Medical Center ( Site 3005)
Tel Aviv, 6423906
IsraelSite Not Available
Georgetown University Medical Center ( Site 1002)
Washington, District of Columbia 20007
United StatesSite Not Available
University of Chicago Medical Center ( Site 1007)
Chicago, Illinois 60637
United StatesSite Not Available
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001)
Boston, Massachusetts 02215
United StatesSite Not Available
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004)
Salt Lake City, Utah 84112
United StatesSite Not Available
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