CARE1: A European study of first-line treatment of metastatic kidney cancer

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CARE1 is a European study coordinated from France. The study aims to help oncologists throughout the world to select the best treatment combination for each kidney cancer patient using a biomarker.

In 2020, Europe saw over 138,000 new cases of clear cell renal cell carcinoma (RCC), the most common form of kidney cancer, resulting in 50,000 deaths (source: GLOBOCAN).

Oncologists from across Europe have come together as the CARE group to determine priorities in research and to launch dedicated kidney cancer clinical trials. This consortium brings together 14 partners representing 8 European countries:

  • France
  • Germany
  • Spain
  • The Netherlands
  • Italy
  • Austria
  • The Czech Republic
  • The United Kingdom.

Rose Woodward, from Action Kidney Cancer is a member of the CARE1 study committee, managing the patient involvement aspects of the study on behalf of the International Kidney Cancer Coalition (IKCC). One of Rose’s first tasks is to form an International Patient Advisory Board of expert kidney cancer patients and advocates from around world to help guide the study.

The study has recently started recruiting patients, but none of the UK sites are open for recruitment at this time. We will keep you informed of where the UK sites are located and when they are open for recruiting patients.

Optimising treatments for metastatic kidney cancer

The treatment of clear cell RCC relies on a combination of two different drugs: targeted therapy (vascular endothelial growth factor receptor tyrosine kinase inhibitor, VEGFR TKI) and immunotherapy (immune checkpoint inhibitors).

However, there has been no direct comparison between these combinations as first-line treatments. Patients have been treated based on the oncologist’s decision, without clinical or biological factors guiding the treatment choice.

CARE1 was designed to determine the best combination for patients using a biomarker. This randomised phase III study aims to recruit 1,250 previously untreated patients with clear cell RCC that has spread (metastasised) from 8 European countries. The combination of two immunotherapies will be compared to the combination of a targeted therapy plus an immunotherapy. This will be based on the presence or absence of a protein receptor called PD-L1 on the patient’s cancer cells.

The presence of the PD-L1 protein receptor for each patient will be determined by a specialist doctor called a pathologist looking at tumour tissue samples at the patient’s hospital. If the tumour has the PD-L1 protein receptor (biomarker), it is PD-L1+, otherwise, it’s PD-L1-.

The main aim of the study is to look at overall survival time in the patients who are PD-L1+. Other aims of the study are overall survival time and the time to when the treatment stops working and the cancer starts growing again (progression-free survival) in the patients who are PD-L1-.

CARE1 will develop guidelines for the best standard of treatment based on the PD-L1 biomarker to improve treatment.

In the long term, data, tumour tissue samples and blood samples will be collected and stored in a ‘biobank’ across Europe.

This programme is supported by a European grant and is coordinated by Professor Laurence Albiges, Head of the Department of Oncology at Gustave Roussy Cancer Centre in France.

For more information about the CARE1 study, please click here or on the image opposite.

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