Study on Nivolumab After Chemotherapy and Radiation for Localized Muscle-Invasive Bladder Cancer

Inclusion Criteria

• Adults aged 18 and older with bladder cancer that has invaded the muscle (stages 2 to 4) and are not candidates for bladder removal surgery.
• Patients may have had part of their bladder removed before starting chemotherapy and radiation.
• Cancer must be confirmed by a doctor and must be of a specific type, such as adenocarcinoma or transitional cell carcinoma.
• Patients must have received chemotherapy and radiation therapy.
• Patients must have good overall health with a performance status score of 2 or less.
• Adequate blood cell counts and organ function, including:
  • White blood cells over 2000/µl
  • Neutrophils over 1500/µl
  • Hemoglobin over 9.0 g/dl
  • Normal liver function tests
  • Creatinine clearance of 20 ml/min or greater
• Able to start the study treatment within 90 days of finishing chemotherapy and radiation.
• Women of childbearing potential must have a negative pregnancy test and agree to use two methods of birth control during the study and for five months after.
• Men must agree to use contraception during the study and for seven months after.
• Willing to provide informed consent and follow study procedures.

Exclusion Criteria

• Cancer that has spread beyond the bladder or to lymph nodes not treated with radiation.
• Other active cancers requiring treatment, except for certain skin cancers.
• Bladder cancer that cannot be fully treated with radiation.
• Inflammatory bowel disease.
• Active autoimmune diseases, except for certain conditions like vitiligo or type I diabetes.
• Need for systemic steroids or immunosuppressive drugs within 14 days of starting the study.
• Chronic immune system issues, HIV, or active hepatitis B or C.
• Pregnant or breastfeeding women, or those not willing to use contraception.
• Severe health conditions or a life expectancy of less than two years.