Phase II Study of Atezolizumab with Cisplatin and Gemcitabine Before Bladder Cancer Surgery

Inclusion Criteria

• Must be 18 years or older.
• Have a good performance status (ECOG 0 or 1).
• Meet specific blood test requirements, including:
  • Neutrophil count of at least 1500 cells/mm³.
  • Lymphocyte count of at least 300/mm³.
  • Platelet count of at least 100,000 cells/mm³.
  • Hemoglobin level of at least 9.0 g/dL.
  • Bilirubin level within normal limits, with exceptions for Gilbert's disease.
  • Liver enzymes (AST and ALT) within specified limits.
  • Alkaline phosphatase within specified limits.
• Women of childbearing potential must have a negative pregnancy test.
• Must provide a tumor sample for research.
• Must agree to undergo biopsies during treatment.
• Have measurable disease and a tumor site suitable for biopsy.
• Have a life expectancy of at least 12 weeks.
• Have confirmed urothelial carcinoma of the bladder, ureter, urethra, or renal pelvis.
• Have locally advanced or metastatic disease.
• Have adequate kidney function.

Phase 2 Cohort:

• Have muscle-invasive urothelial carcinoma of the bladder.
• Be a candidate for bladder removal surgery.
• Have adequate kidney function.

Exclusion Criteria

• Have severe heart disease or serious medical or psychiatric conditions.
• Have significant nerve damage or hearing loss.
• Have had major surgery recently or need major surgery during the study.
• Have had recent heart attacks, severe chest pain, or strokes.
• Have ongoing heart rhythm problems, except stable atrial fibrillation.
• Have HIV or AIDS-related illness.
• Be pregnant, breastfeeding, or planning to become pregnant.
• Have a history of autoimmune diseases, except controlled hypothyroidism or Type I diabetes.
• Have lung diseases like pulmonary fibrosis or pneumonitis.
• Have active hepatitis B or C infections.
• Have active tuberculosis or severe infections recently.
• Have had a stem cell or organ transplant.
• Have received a live vaccine recently.
• Have unresolved side effects from previous cancer treatments.
• Have significant liver disease or bone marrow disorders.
• Have untreated or active brain cancer or metastases.
• Have skin conditions like eczema or psoriasis, unless well-controlled.
• Have other serious diseases or conditions that could interfere with the study.
• Have had other cancers recently, except certain non-threatening types.

Medication-Related Exclusion Criteria:

• Have had certain immune therapies or investigational drugs recently.
• Be taking immunosuppressive medications, except for specific low-dose uses.
• Have severe allergies to certain drugs or components of atezolizumab.

Phase I Cohort:

• Have had prior chemotherapy or immunotherapy for metastatic bladder cancer, except under specific conditions.
• Have had recent cancer treatments, except for certain exceptions.
• Have uncontrolled pain or fluid buildup in the body.

Phase 2 Cohort:

• Have had prior systemic chemotherapy or radiation to the bladder.
• Have had recent cancer treatments, except for certain exceptions.