Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
2 other identifiers
interventional
720
9 countries
44
Brief Summary
The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
Longer than P75 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2025
CompletedFirst Posted
Study publicly available on registry
June 10, 2025
CompletedStudy Start
First participant enrolled
September 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
April 28, 2026
June 1, 2025
2.6 years
June 2, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
up to approximately 33 months
Secondary Outcomes (6)
Overall Survival (OS)
up to approximately 64 months
Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
up to approximately 33 months
Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
up to approximately 33 months
Disease Control Rate (DCR) by Blinded Independent Central Review (BICR)
up to approximately 33 months
The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs)
up to approximately 33 months
- +1 more secondary outcomes
Study Arms (2)
Arm A (Experimental Arm)
EXPERIMENTALCasdatifan and cabozantinib taken orally
Arm B (Comparator Arm)
PLACEBO COMPARATORPlacebo and cabozantinib taken orally
Interventions
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.
- 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, ≤ 1 week prior to randomization.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
You may not qualify if:
- Received prior treatment with a HIF-2α inhibitor or cabozantinib.
- Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
- Ongoing 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, defined as a sustained blood pressure \> 150 mmHg systolic or \> 90 mmHg diastolic despite optimal antihypertensive treatment.
- History of leptomeningeal disease or spinal cord compression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
City of Hope - Phoenix Cancer Center
Goodyear, Arizona, 85338, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054, United States
City Of Hope National Medical Center
Duarte, California, 91010, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92103, United States
UCLA Hematology Oncology - 100 Med Plaza
Los Angeles, California, 90095, United States
University of California San Diego Moores Cancer Center
San Diego, California, 92103, United States
Yale University
New Haven, Connecticut, 06519, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Piedmont Cancer Institute OneOncology
Atlanta, Georgia, 30318, United States
Emory University - Atlanta
Atlanta, Georgia, 30322, United States
City of Hope Cancer Center Atlanta
Newnan, Georgia, 30265, United States
City of Hope - Chicago Cancer Center
Zion, Illinois, 60099, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Norton Cancer Institute PARENT
Louisville, Kentucky, 40207, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
The University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
UNC Hospitals
Chapel Hill, North Carolina, 27514, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44106, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Compass Oncology, OR
Portland, Oregon, 97212, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Vanderbilt
Nashville, Tennessee, 37232, United States
Texas Tech University Health Science Center
Lubbock, Texas, 79430, United States
The University of Utah - Huntsman Cancer Institute (HCI)
Salt Lake City, Utah, 84112, United States
CHU Brest - Hôpital Morvan
Brest, France
Hopital Saint Eloi
Montpellier, France
Institut Gustave Roussy
Villejuif, France
Krankenhaus Nordwest GmbH
Frankfurt, Germany
Universitaetsklinikum Halle (Saale)
Halle, Germany
Universitaetsmedizin Rostock
Rostock, Germany
Radboudumc
Nijmegen, Netherlands
Isala
Zwolle, Netherlands
Pratia MCM Krakow
Krakow, Poland
S.C. Sigmedical Services SRL
Suceava, Romania
S.C Oncomed S.R.L
Timișoara, Romania
CHA Bundang Medical Center, CHA University
Seongnam, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hospital Clinic de Barcelona
Barcelona, Spain
Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom
Barts Hospital
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Arcus Biosciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2025
First Posted
June 10, 2025
Study Start
September 8, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
December 1, 2030
Last Updated
April 28, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.