NCT07011719From ClinicalTrials.govRecruiting

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

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

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

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Arcus Biosciences, Inc.
Enrolment target: 720
Started: 8 September 2025
Main results due: April 2028
Study sites: 183
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(183)

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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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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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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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Camperdown, 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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Showing 60 of 183 sites — filter to narrow it down. 183 of the 183 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07011719. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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