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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 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

2026-05-14

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 (97)

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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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La Jolla, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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New Haven, Connecticut, 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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Rochester, New York, United States

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Chapel Hill, 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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Chermside, Australia

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Hobart, Australia

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Kurralta Park, Australia

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Subiaco, Australia

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Montreal, Canada

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Toronto, Canada

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Prague, Czechia

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Angers, France

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Brest, France

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Montpellier, France

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Paris, France

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Poitiers, France

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Rennes, France

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Strasbourg, France

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Villejuif, France

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Berlin, Germany

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Dresden, Germany

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Frankfurt, Germany

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Halle, Germany

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Rostock, Germany

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Terni, Italy

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Nijmegen, Netherlands

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Rotterdam, Netherlands

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Zwolle, Netherlands

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Auckland, New Zealand

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Christchurch, New Zealand

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Krakow, Poland

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Otwock, Poland

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Poznan, Poland

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Rzeszów, Poland

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Skorzewo, Poland

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Tomaszów Mazowiecki, Poland

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Craiova, Romania

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Suceava, Romania

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Timișoara, Romania

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Busan, South Korea

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Daejeon, South Korea

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Goyang, South Korea

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Seongnam, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Santander, Spain

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Seville, Spain

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Vigo, Spain

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Cambridge, United Kingdom

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Exeter, United Kingdom

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Glasgow, United Kingdom

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Leeds, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Preston, United Kingdom

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Southampton, United Kingdom

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Sutton, United Kingdom

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Truro, United Kingdom