Clinical Trial Details
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Phase IIIInterventional
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
Protocol: 2025P013725NCT: NCT07011719
Overview
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 for patients who received anti-PD-1 or anti-PD-L1 therapy as part of the most recent regimen (either adjuvant monotherapy or first-line in combination with anti-CTLA-4 or VEGFR-TKI), with no more than 1 prior regimen in the metastatic setting.
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
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.
Investigators
Locations
Emory University Hospital Midtown
Emory Saint Joseph's Hospital
Winship Cancer Institute