RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Arcus Biosciences, Inc. • ClinicalTrials.gov ID: NCT07011719

Registry updated: 2026-09-29

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Description

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.

Interventions

Casdatifan (Drug)
Administered as specified in the treatment arm
Cabozantinib (Drug)
Administered as specified in the treatment arm
Placebo (Drug)
Administered as specified in the treatment arm

Eligibility criteria

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.

Conditions

Metastatic Clear Cell Renal Cell Carcinoma Advanced Clear Cell Renal Cell Carcinoma

Locations

Research Site — Gilbert, Arizona, United States
Research Site — Goodyear, Arizona, United States
Research Site — Phoenix, Arizona, United States
Research Site — Duarte, California, United States
Research Site — Irvine, California, United States
Research Site — La Jolla, California, United States
Research Site — Los Angeles, California, United States
Research Site — Palo Alto, California, United States
Research Site — Sacramento, California, United States
Research Site — San Diego, California, United States
Research Site — Aurora, Colorado, United States
Research Site — New Haven, Connecticut, United States
Research Site — Washington D.C., District of Columbia, United States
Research Site — Jacksonville, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Newnan, Georgia, United States
Research Site — Zion, Illinois, United States
Research Site — Indianapolis, Indiana, United States
Research Site — Louisville, Kentucky, United States
Research Site — Jefferson, Louisiana, United States
Research Site — Baltimore, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Boston, Massachusetts, United States
Research Site — Rochester, Minnesota, United States
Research Site — St Louis, Missouri, United States
Research Site — Omaha, Nebraska, United States
Research Site — New Brunswick, New Jersey, United States
Research Site — Buffalo, New York, United States
Research Site — New York, New York, United States
Research Site — Rochester, New York, United States
Research Site — Chapel Hill, North Carolina, United States
Research Site — Durham, North Carolina, United States
Research Site — Cleveland, Ohio, United States
Research Site — Portland, Oregon, United States
Research Site — Monroeville, Pennsylvania, United States
Research Site — Charleston, South Carolina, United States
Research Site — Nashville, Tennessee, United States
Research Site — Nashville, Tennessee, United States
Research Site — Dallas, Texas, United States
Research Site — Lubbock, Texas, United States
Research Site — Salt Lake City, Utah, United States
Research Site — Charlottesville, Virginia, United States
Research Site — Seattle, Washington, United States
Research Site — Buenos Aires, Argentina
Research Site — La Plata, Argentina
Research Site — Pilar, Argentina
Research Site — Rosario, Argentina
Research Site — Viedma, Argentina
Research Site — Box Hill, Australia
Research Site — Camperdown, 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 — South Brisbane, Australia
Research Site — St Albans, Australia
Research Site — Subiaco, Australia
Research Site — Westmead, Australia
Research Site — Calgary, Canada
Research Site — Edmonton, Canada
Research Site — Hamilton, Canada
Research Site — London, 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 — České Budějovice, 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 — Florence, Italy
Research Site — Genova, Italy
Research Site — Milan, Italy
Research Site — Naples, Italy
Research Site — Padua, Italy
Research Site — Perugia, Italy
Research Site — Rome, Italy
Research Site — Rozzano, Italy
Research Site — Terni, Italy
Research Site — Verona, Italy
Research Site — Akita, Japan
Research Site — Asahikawa, Japan
Research Site — Fukuoka, Japan
Research Site — Hidaka, Japan
Research Site — Hiroshima, Japan
Research Site — Kobe, Japan
Research Site — Matsuyama, Japan
Research Site — Nagoya, Japan
Research Site — Nankoku, Japan
Research Site — Osaka, Japan
Research Site — Sapporo, Japan
Research Site — Shinjuku, Japan
Research Site — Tokyo, 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 — Warsaw, 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 — Singapore, Singapore
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 — Majadahonda, Spain
Research Site — Málaga, Spain
Research Site — Pamplona, 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
Research Site — Whitchurch, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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