Casdatifan plus cabozantinib versus placebo plus cabozantinib for advanced clear cell kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 3 trial compares casdatifan plus cabozantinib against placebo plus cabozantinib in adults with advanced or metastatic clear cell renal cell carcinoma who have progressed on prior anti–PD‑1/PD‑L1 therapy. The primary outcome is progression-free survival, with patients required to have measurable disease per RECIST 1.1 and a Karnofsky performance status of 80% or higher. Key exclusions include prior treatment with a HIF‑2α inhibitor or cabozantinib and recent uncontrolled toxicities from prior anticancer therapies. The trial is being conducted at multiple U.S. cancer centers including City of Hope and Mayo Clinic locations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Gilbert, Arizona, United States Recruiting
• Research Site
  Goodyear, Arizona, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Duarte, California, United States Recruiting
• Research Site
  Irvine, California, United States Recruiting
• Research Site
  La Jolla, California, United States Recruiting

+141 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Medical Director
• Email: clinicaltrials@arcusbio.com
• Phone: +1-510-462-3330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.