Study on Durvalumab Alone and Durvalumab with Olaparib for Advanced Bladder Cancer in Patients Who Cannot Use Platinum-Based Chemotherapy

Inclusion Criteria

• Must provide signed consent to participate.
• Have a confirmed diagnosis of advanced bladder cancer that cannot be surgically removed.
• Have not received any prior treatment for advanced bladder cancer.
• Cannot undergo platinum-based chemotherapy due to specific health conditions, such as reduced kidney function, hearing loss, nerve damage, heart failure, or poor overall health.
• Must know the mutation status of their tumor before starting the study.
• Have a performance status indicating they are fully active or have some limitations but are still able to care for themselves.
• Have at least one measurable tumor.
• Must be able to swallow pills.
• Women must be post-menopausal or have a negative pregnancy test if they are of childbearing age.

Exclusion Criteria

• Have active or past autoimmune or inflammatory diseases.
• Have had another invasive cancer within the last 5 years.
• Have had major surgery within the last 28 days.
• Have brain or spinal cord cancer unless stable and off steroids for at least 14 days.
• Have a history of immune system deficiencies.
• Have an active infection, including tuberculosis.
• Have had an organ transplant.
• Have uncontrolled illnesses.
• Have previously used PARP inhibitors or immune therapies.
• Are currently receiving other cancer treatments.
• Have used immunosuppressive drugs within 14 days before starting the study.
• Have had recent radiation therapy unless it meets specific criteria.
• Have received a live vaccine within 30 days before starting the study.
• Are allergic to Durvalumab, Olaparib, or their ingredients.
• Are pregnant, breastfeeding, or not using effective birth control if of reproductive potential.