Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
NCT ID: NCT07011719
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
720 participants
INTERVENTIONAL
2025-09-08
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A (Experimental Arm)
Casdatifan and cabozantinib taken orally
Casdatifan
Administered as specified in the treatment arm
Cabozantinib
Administered as specified in the treatment arm
Arm B (Comparator Arm)
Placebo and cabozantinib taken orally
Cabozantinib
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Interventions
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Casdatifan
Administered as specified in the treatment arm
Cabozantinib
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A Karnofsky Performance Status (KPS) score ≥ 80%
* At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.
* Adequate organ and marrow function, ≤ 72 hours prior to randomization.
* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
Exclusion Criteria
* Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
* Clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.
* Uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure \> 140/90 mm Hg on more than three antihypertensives
* History of leptomeningeal disease or spinal cord compression.
18 Years
ALL
No
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences
Locations
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City of Hope - Phoenix Cancer Center
Goodyear, Arizona, United States
City Of Hope National Medical Center
Duarte, California, United States
University of California San Diego Moores Cancer Center
La Jolla, California, United States
University of California San Diego Moores Cancer Center
San Diego, California, United States
Piedmont Cancer Institute OneOncology
Atlanta, Georgia, United States
City of Hope Cancer Center Atlanta
Newnan, Georgia, United States
City of Hope - Chicago Cancer Center
Zion, Illinois, United States
Norton Cancer Institute PARENT
Louisville, Kentucky, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Compass Oncology, OR
Portland, Oregon, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Countries
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Central Contacts
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Other Identifiers
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2024-515023-11-00
Identifier Type: CTIS
Identifier Source: secondary_id
PEAK-1
Identifier Type: -
Identifier Source: org_study_id