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 (PEAK-1)

未提供0 个研究点目标入组 65 人开始时间: 待定

适应症

试验速览

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•Unresectable 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

•Received prior treatment with a HIF-2alpha 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.

发起方

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