CARE1 Pragmatic Clinical Trial

Systemic therapy for renal cell carcinoma (RCC) relies on 2 classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD1/PDL1 axis or CTLA4. Combination therapy is SOC for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the 2 approaches and patients are treated based on physician decision without clinical /biomarker factors to guide treatment selection. PDL1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PDL1(+) and ICI-VEGFR TKI in PDL1(-) patients. Study design has been developed to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging Overall Survival (OS) for PDL1(+) patients and to demonstrate that ICI-VEGFR TKI is superior to ICI-ICI in prolonging Progression Free Survival (PFS) and OS for PDL1(-) patients.

NCT Number	NCT06364631
Lead Sponsor	Gustave Roussy, Cancer Campus, Grand Paris Collaborators: European Commission, CRIS Cancer Foundation, National Cancer Institute, France, Rennes University Hospital, University Hospital, Essen, Fundació Privada Institut d'Investigació Oncològica de Vall d'Hebron, The Netherlands Cancer Institute, Servicio Madrileño de Salud, Madrid, Spain, Hospital Universitario 12 de Octubre, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Medical University of Vienna, FAKULTNI NEMOCNICE OLOMOUC, International Kidney Cancer Coalition, Association pour la Recherche sur les Tumeurs du Rein, Resilience, PRIMAA, Queen Mary University of London
Conditions	Metastatic Kidney Cancer, Metastatic Kidney Carcinoma
Enrollment	1,250 participants
Start Date	2024-04-12
Primary Completion	2032-05-05 (estimated)
Study Completion	2032-05-05 (estimated)
Updated on ClinicalTrials.gov	2025-01-16