Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364631
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-04
Brief Title:
CARE1 Pragmatic Clinical Trial
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
First Line Randomised Study Platform to Optimize Treatment in Patients With Metastatic Renal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE1
Brief Summary:
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 PD1PDL1 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
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
Detailed Description:
In 2020 there were an estimated 431 288 new cases of kidney cancer Renal Cell Carcinoma RCC globally with 138 611 cases in Europe leading to 179 368 deaths worldwide including 54 054 deaths in Europe source IARCGlobocan To define high priority topics in academic research and launch dedicated trials European RCC academic physicians have gathered into a European initiative - the CARE group
Systemic therapy for RCC relies on two classes of agents anti-angiogenic targeted therapy Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI and immune checkpoint inhibitor ICI targeting either PD-1PD-L1 axis or CTLA-4 Combination therapy is standard of care 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 two approaches and patients are treated based on physician decision without clinical or biomarker factors to guide treatment selection PD-L1 staining is to date the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PD-L1 and ICI-VEGFR TKI in PD-L1- patients
CARE1 PCT is a prospective randomize phase III study in first line setting for patients with metastatic clear cell RCC comparing ICI-ICI vs ICI-VEGFR TKI approaches stratified on PD-L1 by local determination Primary endpoint is overall survival OS The trial will enroll 1250 patients over 4 years across eight European countries France Spain Netherlands Czech Republic Austria Germany Italy UK that are part of the CARE consortium Study Sponsor is Gustave Roussy institute within the GETUG network for France co-sponsor is developed through main academic networks eg SOGUG in Spain and main institutions across Europe eg Cancer Core Europe - CCE Study design has been develop to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging OS for PD-L1 patients and that ICI-VEGFR TKI is superior to ICI-ICI in prolonging OS for PD-L1- patients CARE1 PCT has been designed and will be conducted with patient advocacy group representatives ARTuR and IKCC input
CARE1 is an academic phase III study designed to define the optimal combination using a pragmatic routinely implementable biomarker Therefore CARE1 will inform practice and has the potential to change treatment guidelines Taken all together CARE1 is a unique opportunity to build a large-scale platform to define new biomarker based therapy guidelines as well as to investigate quality of life patient reported outcome and Health-Economic in front line setting as well as pathological and blood biobank collection for further translational work This action is part of the Cancer Mission cluster of projects on Diagnosis and treatment
Systemic therapy for RCC relies on two classes of agents anti-angiogenic targeted therapy Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI and immune checkpoint inhibitor ICI targeting either PD-1PD-L1 axis or CTLA-4 Combination therapy is standard of care 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 two approaches and patients are treated based on physician decision without clinical or biomarker factors to guide treatment selection PD-L1 staining is to date the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PD-L1 and ICI-VEGFR TKI in PD-L1- patients
CARE1 PCT is a prospective randomize phase III study in first line setting for patients with metastatic clear cell RCC comparing ICI-ICI vs ICI-VEGFR TKI approaches stratified on PD-L1 by local determination Primary endpoint is overall survival OS The trial will enroll 1250 patients over 4 years across eight European countries France Spain Netherlands Czech Republic Austria Germany Italy UK that are part of the CARE consortium Study Sponsor is Gustave Roussy institute within the GETUG network for France co-sponsor is developed through main academic networks eg SOGUG in Spain and main institutions across Europe eg Cancer Core Europe - CCE Study design has been develop to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging OS for PD-L1 patients and that ICI-VEGFR TKI is superior to ICI-ICI in prolonging OS for PD-L1- patients CARE1 PCT has been designed and will be conducted with patient advocacy group representatives ARTuR and IKCC input
CARE1 is an academic phase III study designed to define the optimal combination using a pragmatic routinely implementable biomarker Therefore CARE1 will inform practice and has the potential to change treatment guidelines Taken all together CARE1 is a unique opportunity to build a large-scale platform to define new biomarker based therapy guidelines as well as to investigate quality of life patient reported outcome and Health-Economic in front line setting as well as pathological and blood biobank collection for further translational work This action is part of the Cancer Mission cluster of projects on Diagnosis and treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20233764 | OTHER | CSET number | None |