CARE1

• Research type

  Research Study

• Full title

  CARE1: FIRST LINE RANDOMISED STUDY PLATFORM TO OPTIMIZE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA

• IRAS ID

  1010455

• Contact name

  Maia Claveau

• Contact email

  maia.claveau@gustaveroussy.fr

• Sponsor organisation

  Gustave Roussy

• ISRCTN Number

  ISRCTN14485336

• Clinicaltrials.gov Identifier

  NCT06364631

• Research summary

  Treating kidney cancer (renal cell carcinoma, RCC) uses two main types of drugs:
  1. Targeted therapies (anti-angiogenic drugs): These block signals that help tumors grow new blood vessels, like Vascular endothelial growth factor Tyrosine Kinase Inhibitor (VEGFR TKIs).
  2. Immunotherapy: These boost the immune system by targeting proteins like Human programmed death-1/Human programmed death ligand-1 (PD1/PDL1) or Cytotoxic T-lymphocyte associated protein 4 (CTLA4).

  For clear cell RCC (a common type of RCC), combining these treatments is the standard approach. There are two common combinations:
  - Two immunotherapy drugs together (ICI-ICI)
  - One immunotherapy drug with a targeted therapy (ICI-VEGFR TKI)

  Doctors decide which combination to use, but there’s no strong guidance from clinical tests or biomarkers yet. The only useful test so far is PDL1 staining, which helps predict which approach might work better:
  - PDL1-positive patients often respond better to ICI-ICI.
  - PDL1-negative patients tend to benefit more from ICI-VEGFR TKI.

  This study is designed to confirm this research question:
  - For PDL1-positive patients, whether ICI-ICI works better at extending life (overall survival, OS).
  - For PDL1-negative patients, whether ICI-VEGFR TKI improves both time without disease progression (PFS) and overall survival (OS).

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  25/SC/0057

• Date of REC Opinion

  27 Mar 2025

• REC opinion

  Further Information Favourable Opinion