eligibility_summary
Eligible: Enrolled in NureCombo (NCT04876313), SURE-01 (NCT05226117), or SURE-02 (NCT05535218), or candidates for radical cystectomy, histologically confirmed urothelial carcinoma, ECOG 0–1, clinical stage T2–T4N0M0 (MIBC). Exclude: refusal to participate or unavailable baseline tumor/blood samples.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06341478 is an umbrella biomarker study in muscle-invasive bladder cancer testing neoadjuvant regimens vs upfront cystectomy. Interventions: sacituzumab govitecan (SG, antibody-drug conjugate targeting Trop-2, delivering SN-38, a topoisomerase I inhibitor), SG + pembrolizumab (anti–PD-1 monoclonal antibody), nivolumab (anti–PD-1 monoclonal antibody) + nab-paclitaxel/Abraxane (albumin-bound paclitaxel, microtubule-stabilizing chemotherapy), and cystectomy alone. Targets/mechanisms: SG binds Trop-2 on tumor cells, releasing SN-38 to cause DNA damage, pembrolizumab/nivolumab block PD-1 on T cells, restoring antitumor immunity via the PD-1/PD-L1 pathway, nab-paclitaxel disrupts mitosis and may enhance antigen release/immune priming. The study profiles tumor and immune compartments (TILs, myeloid cells, peripheral immune subsets), molecular subtypes, and MRI/FDG-PET to link pathway activity to response.