Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC

Inclusion Criteria: * Participants must have histologically confirmed MIBC (T2-T4a, N0-N1, M0 per American Joint Commission on Cancer \[AJCC\]) pure or mixed histology urothelial carcinoma. Clinical node- positive (N1) patients are eligible provided the lymph nodes (LNs) are within the planned surgical LN dissection template. * The initial TURBT that showed muscularis propria invasion should be within 90 days prior to beginning study therapy. Participants must have sufficient baseline tumor tissue from either initial or repeat TURBTs. The local site pathologist will be asked to estimate and record the rough approximate percentage of viable tumor in the TURBT sample (initial or repeat TURBT with highest tumor content) to document at least 20% viable tumor content prior to registration. This is to ensure adequate tissue is available to perform tumor infiltrating CD8+ T-cell assessment. (The actual CD8+ T cell analysis will be done by a Central Laboratory and will not be done prior to registration.) * Participants must be ineligible for cisplatin-based chemotherapy due to any of the following: * Creatinine clearance (CrCl) \< 60 mL/min (with ECOG Performance Status (PS) 0-1) * Hearing impaired ≥ Grade 2 by CTCAE criteria * Neuropathy ≥ Grade 2 by CTCAE criteria * Heart failure NYHA ≥ III * ECOG ≥ 2 * Refusing to undergo cisplatin chemotherapy * Participants must be medically fit for TURBT and radical cystectomy (RC) * Age ≥ 18 years * Ability to understand and will…