Imagine trying to pick the right key for a lock without knowing which one fits. Right now, doctors guess which drug combination works best for kidney cancer patients. This project tests a specific biological marker to act as a guide, ensuring the right patient gets the right medicine from the start.
Doctors currently lack a standardized, biomarker-based method to choose between two effective but different combination therapies for metastatic kidney cancer. This leads to inconsistent treatment selection and potentially suboptimal patient outcomes.
A phase III pragmatic clinical trial platform and a large-scale patient database for biomarker and health-economic research.
If you are a drug developer dealing with inefficient patient stratification in clinical trials — this project developed a phase III study platform that uses PD-L1 markers to predict treatment success. This allows for more precise targeting of 1250 patients to improve overall survival rates.
If you are a diagnostics company dealing with low adoption of specific cancer tests — this project developed a pragmatic clinical trial that validates PD-L1 staining as a guide for treatment selection. This creates a direct clinical need for these tests in first-line kidney cancer care.
If you are an insurance provider dealing with high costs of ineffective cancer therapies — this project developed a health-economic analysis of first-line settings. This helps in determining which combination therapy provides the best value for money based on patient biomarkers.
Based on available project data, specific costs or pricing for the treatments are not provided; the project focuses on clinical efficacy and overall survival.
Yes, the project is a multicenter, multinational trial involving 22 partners across 14 countries, designed to inform global treatment guidelines.
Based on available project data, this is an academic phase III study; IP details are not mentioned, but it creates a large database for prognostic and predictive biomarker research.
The trial was submitted via the Clinical Trial Information System (CTIS) Portal and received approval on April 2, 2024, in compliance with EU Regulation 536/2014.
The project runs from May 2023 to April 2028, with patient enrollment planned over 3 years.
The consortium is heavily academic and clinical, led by Institut Gustave Roussy with 22 partners. It features a low industry ratio of 14% (3 industry partners, including 1 SME), indicating the project is driven by clinical validation rather than immediate commercial product development. The broad geographic spread across 14 countries ensures the results are applicable to diverse European populations.
Contact Institut Gustave Roussy regarding the CARE1 Pragmatic Clinical Trial
Contact us to connect with the CARE1 consortium for biomarker data access.
