Study on the Safety of Immunotherapy with Nivolumab Alone or with Ipilimumab Before Surgery for Bladder Cancer Patients Who Cannot Have Chemotherapy

Inclusion Criteria

• Diagnosed with bladder cancer, specifically urothelial carcinoma, with a predominant urothelial component.
• For muscle-invasive bladder cancer: confirmed disease stage cT2-4a cN0 cM0, including certain cases with prostatic stroma invasion.
• For upper urinary tract cancer: high-grade urothelial carcinoma with specific tumor stages and positive urinary cytology.
• Not eligible for cisplatin chemotherapy due to certain health conditions, such as reduced kidney function, hearing loss, or nerve damage.
• Must provide a tumor sample from diagnosis.
• Good overall health with a performance status of 70% or higher.
• Suitable for bladder removal surgery as determined by a specialist.
• Aged 18 years or older.
• Meet specific blood test requirements for neutrophils, platelets, liver function, and blood clotting.
• Not on blood thinners unless on a stable dose.

Exclusion Criteria

• Previous chemotherapy for bladder cancer, except for certain local treatments like BCG.
• Previous radiation therapy directed at the bladder for muscle-invasive cancer.
• Active autoimmune diseases, except for certain stable conditions like type I diabetes or skin disorders not needing systemic treatment.
• Need for systemic steroids or immunosuppressive drugs within 14 days before starting the study.
• Unstable heart conditions or recent heart attack or stroke.
• Bleeding disorders, unless on stable anticoagulation.
• Major surgery within 28 days before the study, except for certain bladder procedures.
• Serious wounds or fractures that are not healing.
• Other active cancers within the last 2 years, except for certain early-stage cancers.
• Previous treatment with specific immune therapies targeting T cells, except for IL-2.
• Recent BCG treatment within 6 weeks of starting the study.
• Positive tests for hepatitis B or C, or HIV.
• Allergies to study drugs or severe reactions to monoclonal antibodies.
• Pregnant or breastfeeding women.
• Men unwilling to use contraception during and after treatment.
• Women of childbearing potential not using effective contraception during and after treatment.
• Individuals detained for psychiatric or infectious disease treatment.
• Inability to comply with study procedures.