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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT07011719
Run by: Arcus Biosciences, Inc.
People needed: 720
Starts: 2025-09-08
Expected to finish: 2030-12-01
Last updated by the study team: 2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Goodyear, Arizona, United States (enrolling)
Research Site — Phoenix, Arizona, United States (enrolling)
Research Site — Duarte, California, United States (enrolling)
Research Site — Irvine, California, United States (enrolling)
Research Site — La Jolla, California, United States (enrolling)
Research Site — Los Angeles, California, United States (enrolling)
Research Site — Sacramento, California, United States (enrolling)
Research Site — San Diego, California, United States (enrolling)
Research Site — New Haven, Connecticut, United States (enrolling)
Research Site — Washington D.C., District of Columbia, United States (enrolling)
Research Site — Jacksonville, Florida, United States (enrolling)
Research Site — Miami, Florida, United States (enrolling)
Research Site — Orlando, Florida, United States (enrolling)
Research Site — Atlanta, Georgia, United States (enrolling)
Research Site — Atlanta, Georgia, United States (enrolling)
Research Site — Newnan, Georgia, United States (enrolling)
Research Site — Zion, Illinois, United States (enrolling)
Research Site — Indianapolis, Indiana, United States (enrolling)
Research Site — Louisville, Kentucky, United States (enrolling)
Research Site — Jefferson, Louisiana, United States (enrolling)
Research Site — Baltimore, Maryland, United States (enrolling)
Research Site — Boston, Massachusetts, United States (enrolling)
Research Site — Boston, Massachusetts, United States (enrolling)
Research Site — Rochester, Minnesota, United States (enrolling)
Research Site — Gilbert, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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