eligibility_summary
Adults (>=18) with unresectable/metastatic clear-cell RCC (sarcomatoid allowed), measurable disease, ECOG<=2, adequate organ function, FFPE tumor tissue required. Consent, oral meds, contraception. Exclude prior systemic metastatic RCC therapy (incl ICI/VEGF, CDK4/6) or adjuvant <12 mo, unstable/untreated brain mets, recent RT/surgery/PE/DVT, uncontrolled illness/toxicity, immunosuppression, active HIV/HBV/HCV, major cardiac/ILD or thoracic RT, warfarin, strong CYP3A4 modifiers/herbals, pregnancy, >30 pack-yrs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm study in treatment‑naive metastatic clear cell RCC testing axitinib + avelumab + palbociclib (status: withdrawn). Axitinib: oral small‑molecule VEGFR1/2/3 tyrosine kinase inhibitor, blocks VEGF signaling to inhibit angiogenesis—targets endothelial cells and tumor vasculature pathways. Avelumab: IV anti‑PD‑L1 monoclonal antibody (immune checkpoint inhibitor), blocks PD‑L1 to restore cytotoxic T‑cell activity—targets the PD‑1/PD‑L1 pathway on tumor and immune cells. Palbociclib: oral CDK4/6 inhibitor, prevents Rb phosphorylation to induce G1 arrest—targets the CDK4/6‑Rb cell‑cycle pathway in proliferating tumor cells.