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.
Phase:
PHASE3
Details
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators:
Association pour la Recherche sur les Tumeurs du Rein CRIS Cancer Foundation European Commission FAKULTNI NEMOCNICE OLOMOUC Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Fundació Privada Institut d'Investigació Oncològica de Vall d'Hebron Hospital Universitario 12 de Octubre International Kidney Cancer Coalition Medical University of Vienna National Cancer Institute, France PRIMAA Queen Mary University of London Rennes University Hospital Resilience Servicio Madrileño de Salud, Madrid, Spain The Netherlands Cancer Institute University Hospital, Essen