eligibility_summary
Eligible: ≥18 with adv/metastatic clear‑cell RCC, ECOG ≤2, measurable RECIST disease, any IMDC risk, archival metastatic tissue, adequate organ function. Controlled HIV/HBV/HCV ok. WOCBP: negative test + contraception. Exclude: prior RCC systemic/adjuvant, IO or VEGF/TKI, recent RT/surgery, concurrent anticancer therapy, active/untreated CNS mets, >G1 toxicities, severe allergy/autoimmunity or immunosuppression, infection <14 d, CV disease, other malignancy <2 y, live vaccine <30 d, prior allogeneic tx.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, randomized trial in treatment‑naïve metastatic clear cell RCC comparing: Arm A: botensilimab + balstilimab vs Arm B: ipilimumab + nivolumab. Drug types/mechanisms: • Botensilimab (AGEN1181): Fc‑enhanced anti‑CTLA‑4 monoclonal antibody (immune checkpoint inhibitor) designed to deplete intratumoral regulatory T cells via FcγR/ADCC and enhance T‑cell priming. • Balstilimab (AGEN2034): anti‑PD‑1 monoclonal antibody that blocks PD‑1/PD‑L1/PD‑L2 to restore effector T‑cell function. • Ipilimumab: anti‑CTLA‑4 monoclonal antibody (checkpoint inhibitor). • Nivolumab: anti‑PD‑1 monoclonal antibody (checkpoint inhibitor). Targets/pathways: CTLA‑4 and PD‑1 checkpoints on T cells, depletion of Tregs, activation of CD8+ effector T cells and improved APC–T‑cell priming in the tumor microenvironment.