eligibility_summary
Eligible: ≥18 with Stage IV unresectable/metastatic urothelial carcinoma, measurable disease pre‑chemo, completed 4–6 cycles platinum 4–10 weeks earlier without progression (CR/PR/SD), ECOG 0–2, adequate marrow, renal (CrCl ≥30), and liver function. Exclude: progression, adj/neoadj ≤12 mo, prior IO, recent major surgery/RT, CNS mets on steroids, unresolved >G1 tox, other cancer ≤2 y, autoimmune requiring immunosuppression, serious CV ≤6 mo, active infection, severe allergy, HIV/HBV/HCV, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II (withdrawn) single-arm switch‑maintenance study in metastatic urothelial carcinoma after stable/responding disease on platinum chemo. Interventions: Avelumab—human IgG1 anti‑PD‑L1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD‑1/PD‑L1 (and PD‑L1/CD80) interactions and can trigger ADCC, restoring cytotoxic T‑cell and NK activity. Lurbinectedin (PM01183)—synthetic tetrahydroisoquinoline alkaloid cytotoxic agent that binds the DNA minor groove, stalls RNA polymerase II, suppresses oncogenic transcription, causes DNA breaks, and induces apoptosis, reported immunomodulatory effects on tumor‑supportive myeloid cells. Targets/pathways: PD‑L1 on tumor/immune cells and PD‑1 signaling on T cells, tumor cell transcription machinery/DNA damage pathways, potential depletion/modulation of tumor‑associated macrophages. Aim: prolong disease control with combined immunotherapy + transcription‑inhibiting chemotherapy.