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Clinical Trials in the UK / NCT07011719
Recruiting Phase 3

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

NCT07011719 · tracked via the Priya Life Science UK tracker
Sponsor
Arcus Biosciences, Inc.
Phase
Phase 3
Started
2025-09-08
Last updated
2026-09-02

Condition(s) studied

Metastatic Clear Cell Renal Cell CarcinomaAdvanced Clear Cell Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

CasdatifanCabozantinibPlacebo

Casdatifan: Administered as specified in the treatment arm

Cabozantinib: Administered as specified in the treatment arm

Placebo: Administered as specified in the treatment arm

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (176)

FacilityCityRegionStatus
Research Site Gilbert Arizona Recruiting
Research Site Goodyear Arizona Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Duarte California Recruiting
Research Site Irvine California Recruiting
Research Site La Jolla California Recruiting
Research Site Los Angeles California Recruiting
Research Site Palo Alto California Recruiting
Research Site Sacramento California Recruiting
Research Site San Diego California Recruiting
Research Site Aurora Colorado Recruiting
Research Site New Haven Connecticut Recruiting
Research Site Washington D.C. District of Columbia Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Orlando Florida Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Newnan Georgia Recruiting
Research Site Zion Illinois Recruiting
Research Site Indianapolis Indiana Recruiting
Research Site Louisville Kentucky Recruiting
Research Site Jefferson Louisiana Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Rochester Minnesota Recruiting
Research Site St Louis Missouri Recruiting
Research Site Omaha Nebraska Recruiting
Research Site New Brunswick New Jersey Recruiting
Research Site Buffalo New York Recruiting
Research Site New York New York Recruiting
Research Site Rochester New York Recruiting
Research Site Chapel Hill North Carolina Recruiting
Research Site Durham North Carolina Recruiting
Research Site Cleveland Ohio Recruiting
Research Site Portland Oregon Recruiting
Research Site Monroeville Pennsylvania Recruiting
Research Site Charleston South Carolina Recruiting
Research Site Nashville Tennessee Recruiting

+ 136 more sites — see the full list on the official registry below.

On this site

📄 Cabometyx (cabozantinib) drug profile →

More Arcus Biosciences, Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07011719 on ClinicalTrials.gov ↗ ← All trials in the UK