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Study of Casdatifan and Cabozantinib for Advanced Clear Cell Kidney Cancer

This study is for adults with advanced clear cell renal cell carcinoma (a type of kidney cancer) that has worsened after previous immunotherapy. It compares two treatment approaches: casdatifan plus cabozantinib, versus a placebo (an inactive substance) plus cabozantinib. Researchers want to see if adding casdatifan to cabozantinib can help prevent the cancer from growing or spreading for a longer time. To join, you must have measurable cancer and a good performance status. The study aims to enroll 720 participants, but its current status is unclear.

Study design
This interventional study involves giving participants either casdatifan and cabozantinib, or placebo and cabozantinib. It plans to enroll 720 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, progression-free survival, will be assessed for up to approximately 33 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07011719

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Arcus Biosciences, Inc.
~720 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:CasdatifanCabozantinibPlacebo

At a glance

Recruiting sites
159 of 159 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Measured over up to approximately 33 months

Conditions

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

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Renal Cell Carcinoma

Where it's being run

159 sites across 42 states
France15
Germany13
United Kingdom13
Australia12
Japan10
Canada7
Poland7
Spain7

Study leadership

  • Medical Director · STUDY_DIRECTOR · Arcus Biosciences

Who to contact

Medical Director
[email protected]
+1-510-462-3330
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1up to approximately 33 months