OncoMatch/Clinical Trials/NCT06364631
CARE1 Pragmatic Clinical Trial
Is NCT06364631 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for metastatic kidney cancer.
Treatment: Nivolumab · Ipilimumab · Pembrolizumab · Cabozantinib · Axitinib · Lenvatinib — 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 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Prior therapy
Cannot have received: systemic anticancer therapy
Exception: One prior systemic adjuvant therapy is allowed for completely resected RCC and if recurrence occurred at least 6 months after the last dose of adjuvant therapy.
Prior systemic anticancer therapy for mRCC including investigational agents. Note: One prior systemic adjuvant therapy is allowed for completely resected RCC and if recurrence occurred at least 6 months after the last dose of adjuvant therapy.
Lab requirements
Blood counts
ANC ≥ 1000/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 8 g/dL
Kidney function
Calculated creatinine clearance ≥ 30 mL/min (CKD-EPI equation)
Liver function
ALT and AST ≤ 5 x ULN
Adequate organ and marrow function, according to investigator assessment and: ANC ≥ 1000/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 8 g/dL; ALT and AST ≤ 5 x ULN; Calculated creatinine clearance ≥ 30 mL/min (CKD-EPI equation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify