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CARE1 Pragmatic Clinical Trial

Study acronym: CARE1
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 1 to 46v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 5, 2024 to Apr 12, 2024
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Metastatic Kidney Cancer, Metastatic Kidney Carcinoma
Related terms Carcinoma, Renal Cell, Kidney Neoplasms
Enrollment 1,250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov