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

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

Phase 3 Interventional Arcus Biosciences, Inc. · NCT07011719

This trial tests whether adding casdatifan to cabozantinib helps adults with advanced or metastatic clear cell kidney cancer who progressed after PD‑1 or PD‑L1 immunotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment720 (estimated)
Ages18 Years and up
SexAll
SponsorArcus Biosciences, Inc. Industry-sponsored
Drugs / interventionscabozantinib, radiation, immunotherapy
Locations44 sites (Goodyear, Arizona and 43 other locations)
Trial IDNCT07011719 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable or metastatic clear cell renal cell carcinoma, measurable disease, KPS ≥80%, and prior progression on anti‑PD‑1/PD‑L1 therapy who have not previously received a HIF‑2α inhibitor or cabozantinib.

Not a fit: Patients who previously received a HIF‑2α inhibitor or cabozantinib, have ongoing high-grade toxicities from prior treatments, or have other active recent malignancies are unlikely to be eligible or benefit from this regimen.

Why it matters

Potential benefit: If successful, adding casdatifan to cabozantinib could prolong the time without disease progression for patients whose cancer progressed after prior immunotherapy.

How similar studies have performed: HIF‑2α inhibitors (for example belzutifan) have shown activity in clear cell RCC and cabozantinib is an established therapy, so this combination builds on existing clinical rationale though casdatifan itself remains investigational.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Goodyear, Arizona and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Clear Cell Renal Cell CarcinomaAdvanced Clear Cell Renal Cell CarcinomaCasdatifanKidney CancerPEAK-1AB521ccRCC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.