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RECRUITING
NCT07011719
PHASE3

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Sponsor: Arcus Biosciences, Inc.

View on ClinicalTrials.gov

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 for patients who received anti-PD-1 or anti-PD-L1 therapy as part of the most recent regimen (either adjuvant monotherapy or first-line in combination with anti-CTLA-4 or VEGFR-TKI), with no more than 1 prior regimen in the metastatic setting.

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

2026-11-02

Healthy Volunteers

No

Interventions

DRUG

Casdatifan

Administered as specified in the treatment arm

DRUG

Cabozantinib

Administered as specified in the treatment arm

DRUG

Placebo

Administered as specified in the treatment arm

Locations (191)

Research Site

Gilbert, Arizona, United States

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Goodyear, Arizona, United States

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Phoenix, Arizona, United States

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Duarte, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Aurora, Colorado, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Newnan, Georgia, United States

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Zion, Illinois, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Jefferson, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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New Brunswick, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Monroeville, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Lubbock, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Seattle, Washington, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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La Plata, Argentina

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Pilar, Argentina

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Rosario, Argentina

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Viedma, Argentina

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Box Hill, Australia

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Chermside, Australia

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Elizabeth Vale, Australia

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Frankston, Australia

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Frenchs Forest, Australia

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Heidelberg, Australia

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Hobart, Australia

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Kurralta Park, Australia

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Macquarie Park, Australia

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New South Wales, Australia

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South Brisbane, Australia

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St Albans, Australia

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Subiaco, Australia

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Westmead, Australia

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Calgary, Canada

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Edmonton, Canada

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Hamilton, Canada

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London, Canada

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Montreal, Canada

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Sherbrooke, Canada

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Toronto, Canada

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Vancouver, Canada

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Brno, Czechia

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Brno-střed, Czechia

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České Budějovice, Czechia

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Hradec, Czechia

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Prague, Czechia

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Angers, France

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Brest, France

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Caen, France

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Clermont-Ferrand, France

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Lille, France

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Marseille, France

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Montpellier, France

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Paris, France

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Pessac, France

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Poitiers, France

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Reims, France

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Rennes, France

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Strasbourg, France

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Toulouse, France

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Villejuif, France

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Berlin, Germany

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Dresden, Germany

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Essen, Germany

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Frankfurt, Germany

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Freiburg im Breisgau, Germany

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Halle, Germany

And 91 more locations on ClinicalTrials.gov