eligibility_summary
Eligible: adults (>18) with metastatic renal cell carcinoma per 5th ed. General Rule, unresectable locally advanced or metastatic disease, who received avelumab + axitinib as first-line therapy, index date 20 Dec 2019–17 Oct 2022. Exclude: participation in other prospective interventional trials during observation or refusal of data consent (patient or legal representative).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05650164 (J-DART2) is a multicenter, non-interventional, retrospective chart review of Japanese patients with metastatic renal cell carcinoma receiving first-line avelumab plus axitinib in real-world care. Interventions: • Avelumab: human IgG1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD-L1 from binding PD-1/B7.1, restoring T‑cell antitumor activity, its Fc enables NK cell–mediated ADCC. Targets: PD-L1 on tumor/immune cells, PD-1/PD-L1 checkpoint, T cells and NK cells. • Axitinib: oral small-molecule tyrosine kinase inhibitor of VEGFR-1/2/3, inhibiting VEGF-driven angiogenesis. Targets: VEGF–VEGFR pathway and tumor endothelial cells. Combined IO+TKI approach aims to suppress angiogenesis and enhance antitumor immunity.