Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer

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.
• •Following cardio-vascular risk factors:
• •1. Myocardial infarction in the past 6 months before planned treatment start.
• •2. Uncontrolled heart failure.
• •3. Uncontrolled ventricular arrhythmia.
• •4. A peri/myocarditis in the past 3 months before planned treatment start. Note: Stable atrial fibrillation is permissive with or without anticoagulation if there was no decompensation in the past 3 months before planned treatment start.
• •Left ventricular ejection fraction (LVEF) \< 50% measured by echocardiogram or MUGA.
• •QTcF ≥ 470 ms regardless of sex.
• •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).