Study Of Casdatifan And Cabozantinib Versus Placebo And Cabozantinib In Patients With Advanced Clear Cell Renal Cell Carcinoma

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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, ≤ 72 hours 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.
* 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, as defined by a sustained blood pressure > 140/90 mm Hg on more than three antihypertensives
* History of leptomeningeal disease or spinal cord compression.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/20/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Yousef Zakharia

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Lance Pagliaro

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Arnab Basu

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available