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

Launched by ARCUS BIOSCIENCES, INC. · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of two medications, casdatifan and cabozantinib, in treating patients with advanced clear cell renal cell carcinoma, a type of kidney cancer that has spread and is difficult to treat. The study aims to see if adding casdatifan to cabozantinib can help patients live longer without their cancer getting worse compared to those who receive placebo (a dummy treatment) with cabozantinib. This trial is open to adults aged 65 to 74 who have previously been treated with certain immunotherapy drugs and have measurable cancer that is not able to be surgically removed.

To participate in the trial, potential volunteers must have advanced kidney cancer that can be measured on imaging tests, and they should be in reasonably good health, as indicated by a performance score that reflects their ability to carry out daily activities. However, those who have undergone certain prior treatments, have uncontrolled high blood pressure, or have specific health issues may not be eligible. Participants will receive regular medical check-ups and will be closely monitored throughout the study to track their progress and any side effects. This trial is not yet recruiting, so there’s still time to learn more and consider if it’s the right choice for you or a loved one.

Gender

ALL

Eligibility 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, ≤ 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.