Back to Trials
NCT07011719PHASE3Recruiting

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

Arcus Biosciences, Inc.

Start Date

9/8/2025

Completion Date

12/1/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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. Exclusion Criteria: * 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

Casdatifan

DRUG

Cabozantinib

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Metastatic Clear Cell Renal Cell CarcinomaAdvanced Clear Cell Renal Cell Carcinoma

Locations

Research Site

Gilbert, Arizona 85234

United States

Research Site

Goodyear, Arizona 85338

United States

Research Site

Phoenix, Arizona 85054

United States

Research Site

Duarte, California 91010

United States

Research Site

Irvine, California 91304

United States

Research Site

La Jolla, California 92103

United States

Research Site

Los Angeles, California 90095

United States

Research Site

Sacramento, California 95817

United States

Research Site

San Diego, California 92103

United States

Research Site

New Haven, Connecticut 06519

United States

Research Site

Washington D.C., District of Columbia 20057

United States

Research Site

Jacksonville, Florida 32224

United States

Research Site

Miami, Florida 33136

United States

Research Site

Orlando, Florida 32804

United States

Research Site

Atlanta, Georgia 30318

United States

Research Site

Atlanta, Georgia 30322

United States

Research Site

Newnan, Georgia 30265

United States

Research Site

Zion, Illinois 60099

United States

Research Site

Indianapolis, Indiana 46202

United States

Research Site

Louisville, Kentucky 40207

United States

Research Site

Jefferson, Louisiana 70121

United States

Research Site

Baltimore, Maryland 21287

United States

Research Site

Boston, Massachusetts 02114

United States

Research Site

Boston, Massachusetts 02215

United States

Research Site

Rochester, Minnesota 55905

United States

Research Site

St Louis, Missouri 63110

United States

Research Site

Omaha, Nebraska 68198

United States

Research Site

New Brunswick, New Jersey 08903

United States

Research Site

Buffalo, New York 14263

United States

Research Site

New York, New York 10461

United States

Research Site

Rochester, New York 14642

United States

Research Site

Chapel Hill, North Carolina 27514

United States

Research Site

Durham, North Carolina 27710

United States

Research Site

Cleveland, Ohio 44106

United States

Research Site

Portland, Oregon 97212

United States

Research Site

Monroeville, Pennsylvania 15146

United States

Research Site

Charleston, South Carolina 29425

United States

Research Site

Nashville, Tennessee 37203

United States

Research Site

Nashville, Tennessee 37232

United States

Research Site

Dallas, Texas 75390

United States

Research Site

Lubbock, Texas 79430

United States

Research Site

Salt Lake City, Utah 84112

United States

Research Site

Charlottesville, Virginia 22903

United States

Research Site

Seattle, Washington 98109

United States

Research Site

Buenos Aires,

Argentina

Research Site

Box Hill,

Australia

Research Site

Chermside,

Australia

Research Site

Elizabeth Vale,

Australia

Research Site

Frankston,

Australia

Research Site

Frenchs Forest,

Australia

Research Site

Heidelberg,

Australia

Research Site

Hobart,

Australia

Research Site

Kurralta Park,

Australia

Research Site

Macquarie Park,

Australia

Research Site

Saint Leonards,

Australia

Research Site

Subiaco,

Australia

Research Site

Westmead,

Australia

Research Site

Calgary,

Canada

Research Site

Edmonton,

Canada

Research Site

Hamilton,

Canada

Research Site

Montreal,

Canada

Research Site

Sherbrooke,

Canada

Research Site

Toronto,

Canada

Research Site

Vancouver,

Canada

Research Site

Brno,

Czechia

Research Site

Brno-střed,

Czechia

Research Site

Hradec,

Czechia

Research Site

Prague,

Czechia

Research Site

Angers,

France

Research Site

Brest,

France

Research Site

Caen,

France

Research Site

Clermont-Ferrand,

France

Research Site

Lille,

France

Research Site

Marseille,

France

Research Site

Montpellier,

France

Research Site

Paris,

France

Research Site

Pessac,

France

Research Site

Poitiers,

France

Research Site

Reims,

France

Research Site

Rennes,

France

Research Site

Strasbourg,

France

Research Site

Toulouse,

France

Research Site

Villejuif,

France

Research Site

Berlin,

Germany

Research Site

Dresden,

Germany

Research Site

Essen,

Germany

Research Site

Frankfurt,

Germany

Research Site

Freiburg im Breisgau,

Germany

Research Site

Halle,

Germany

Research Site

Hanover,

Germany

Research Site

Heidelberg,

Germany

Research Site

Leipzig,

Germany

Research Site

Lübeck,

Germany

Research Site

Marburg,

Germany

Research Site

Rostock,

Germany

Research Site

Ulm,

Germany

Research Site

Milan,

Italy

Research Site

Naples,

Italy

Research Site

Rome,

Italy

Research Site

Terni,

Italy

Research Site

Verona,

Italy

Research Site

Akita,

Japan

Research Site

Asahikawa,

Japan

Research Site

Fukuoka,

Japan

Research Site

Kobe,

Japan

Research Site

Matsuyama,

Japan

Research Site

Nankoku,

Japan

Research Site

Osaka,

Japan

Research Site

Sapporo,

Japan

Research Site

Shinjuku,

Japan

Research Site

Yokohama,

Japan

Research Site

Amsterdam,

Netherlands

Research Site

Maastricht,

Netherlands

Research Site

Nijmegen,

Netherlands

Research Site

Rotterdam,

Netherlands

Research Site

Utrecht,

Netherlands

Research Site

Zwolle,

Netherlands

Research Site

Auckland,

New Zealand

Research Site

Christchurch,

New Zealand

Research Site

Hamilton,

New Zealand

Research Site

Rotorua,

New Zealand

Research Site

Krakow,

Poland

Research Site

Otwock,

Poland

Research Site

Poznan,

Poland

Research Site

Rzeszów,

Poland

Research Site

Skorzewo,

Poland

Research Site

Tomaszów Mazowiecki,

Poland

Research Site

Wroclaw,

Poland

Research Site

Bucharest,

Romania

Research Site

Craiova,

Romania

Research Site

Iași,

Romania

Research Site

Suceava,

Romania

Research Site

Timișoara,

Romania

Research Site

Busan,

South Korea

Research Site

Daejeon,

South Korea

Research Site

Goyang,

South Korea

Research Site

Seongnam,

South Korea

Research Site

Seoul,

South Korea

Research Site

Suwon,

South Korea

Research Site

Barcelona,

Spain

Research Site

Córdoba,

Spain

Research Site

Madrid,

Spain

Research Site

Málaga,

Spain

Research Site

Santander,

Spain

Research Site

Seville,

Spain

Research Site

Vigo,

Spain

Research Site

Cambridge,

United Kingdom

Research Site

Cottingham,

United Kingdom

Research Site

Exeter,

United Kingdom

Research Site

Glasgow,

United Kingdom

Research Site

Leeds,

United Kingdom

Research Site

London,

United Kingdom

Research Site

Manchester,

United Kingdom

Research Site

Newcastle upon Tyne,

United Kingdom

Research Site

Northwood,

United Kingdom

Research Site

Preston,

United Kingdom

Research Site

Southampton,

United Kingdom

Research Site

Sutton,

United Kingdom

Research Site

Truro,

United Kingdom