CARE1 Pragmatic Clinical Trial

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 b

Trial Details

NCT ID
NCT06364631
Phase
PHASE3
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Nivolumab
  • Ipilimumab
  • Pembrolizumab
  • Cabozantinib
  • Axitinib
  • Lenvatinib
Locations (sample)
  • Vienna, Austria|48.20849,16.37208
  • Brno, Czechia|49.19522,16.60796
  • Hradec Králové, Czechia|50.20923,15.83277
  • Olomouc, Czechia|49.59552,17.25175
  • Prague, Czechia|50.08804,14.42076

Key Eligibility Criteria

  • Histologically confirmed metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.
  • Intermediate- or poor-risk mRCC as defined by IMDC classification.
  • Adult male or female patients (≥ 18 years of age at inclusion).
  • Karnofsky Performance Status (KPS) ≥70%.

For full eligibility, visit ClinicalTrials.gov.

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