eligibility_summary
Adults ≥18 with high‑risk NMIBC (T1, high‑grade Ta, or CIS), maximally resected, cystectomy‑ineligible/declined, after 2 BCG inductions, ECOG 0–2, life expectancy ≥6 mo, adequate blood counts/organ function, consent and contraception. Exclude active infection (incl TB/UTI), HIV CD4<200, prior PD‑(L)1/CTLA‑4 or IO102/IO103, recent chemo/RT, major cardiac disease, systemic steroids/immunosuppression, ILD/pneumonitis, pregnancy, live vaccine ≤30d, allergy, or other unsafe risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05843448 (Phase I, single-arm) in BCG-unresponsive/intolerant non–muscle invasive bladder cancer. Interventions and mechanisms: • IO102-IO103: a therapeutic peptide vaccine (biologic) composed of PD-L1 and IDO-derived peptides. It aims to induce antigen-specific CD8+/CD4+ T-cell responses against PD-L1– and IDO-expressing cells, enhancing tumor cell killing and depleting immunosuppressive cells in the tumor microenvironment. • Pembrolizumab (Keytruda, MK-3475): a monoclonal antibody checkpoint inhibitor that blocks PD-1 on T cells to restore anti-tumor immunity. Targeted cells/pathways: • PD-1/PD-L1 immune checkpoint axis on tumor and immune cells. • IDO-mediated tryptophan–kynurenine immunosuppressive pathway (IDO-expressing tumor cells, dendritic cells, MDSCs, Tregs). • Effector T cells (CD8+/CD4+) as the activated anti-tumor effectors.