Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer

Main Inclusion Criteria: Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. Male or female aged ≥ 18 years. Histopathologically confirmed urothelial carcinoma. Clinical Stage T2-T4aN0M0 MIBC. Ineligible for cisplatin therapy per modified Galsky criteria or refuses cisplatin-based chemotherapy. Eligible for radical Cystectomy. Pretreatment tumor material from transurethral resection of the bladder tumor (TURBT) must be available. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Adequate organ function (bone marrow, hepatic, renal function and coagulation). Main Exclusion Criteria: Pregnant or breastfeeding. Received prior radiotherapy on the bladder tumor. Received a partial cystectomy. Any prior systemic anti-cancer therapy including investigational agents and immunotherapy for bladder cancer. Pre-existing arrhythmia, uncontrolled angina pectoris, uncontrolled heart failure (NYHA) Grade IV, any myocardial infarction/coronary event, CNS-ischemic event and any thromboembolic event at any time < 6 months prior to Screening or presence of uncontrolled heart failure NYHA Grade III or higher. Left ventricular ejection fraction (LVEF) < 50% measured by echocardiogram or MUGA. QTcF > 450 ms for men or > 470 ms for women. Any active autoimmune requiring systemic immunosuppressive treatments. Any history of non-infectious pneumonitis < 6 months prior to Screening. Any active inflammatory bowel disease such as Crohn's disease or ulcerative colitis which are generally excluded or active autoimmunthyroiditis present < 6 months prior to Screening. History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (< 6 months prior to Screening).