OncoMatch/Clinical Trials/NCT06364631
CARE1 Pragmatic Clinical Trial
Is NCT06364631 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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.
Frequently asked questions
Is NCT06364631 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
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 qualifyRelated pages