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Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Sponsor: Arcus Biosciences, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
720
Start Date
2025-09-08
Completion Date
2030-12
Last Updated
2026-04-01
Healthy Volunteers
No
Interventions
Casdatifan
Administered as specified in the treatment arm
Cabozantinib
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Locations (44)
City of Hope - Phoenix Cancer Center
Goodyear, Arizona, United States
Mayo Clinic - Phoenix
Phoenix, 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
UCLA Hematology Oncology - 100 Med Plaza
Los Angeles, California, United States
University of California San Diego Moores Cancer Center
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Piedmont Cancer Institute OneOncology
Atlanta, Georgia, United States
Emory University - Atlanta
Atlanta, Georgia, United States
City of Hope Cancer Center Atlanta
Newnan, Georgia, United States
City of Hope - Chicago Cancer Center
Zion, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Norton Cancer Institute PARENT
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
The University of Nebraska Medical Center
Omaha, Nebraska, United States
University of Rochester Medical Center
Rochester, New York, United States
UNC Hospitals
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Compass Oncology, OR
Portland, Oregon, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Vanderbilt
Nashville, Tennessee, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
The University of Utah - Huntsman Cancer Institute (HCI)
Salt Lake City, Utah, 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