Last updated 5 days ago
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
720 patients around the world
Available in United States, Argentina
Arcus Biosciences, Inc.
5Research sites
720Patients around the world
This study is for people with
Kidney cancer
Clear Cell Renal Cell Carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro Médico Privado CEMAIC - Córdoba
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Recruiting
Hospital Universitario Austral - Pilar
Centro Oncológico Integral - La Plata
Instituto de Oncología de Rosario - IOR
StudyPEAK-1
SponsorArcus Biosciences, Inc.
Study typeInterventional
Conditions
Clear Cell Renal Cell Carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07011719
