A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)

Exclusion Criteria

• •Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC
• •Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions
• •Has a known additional malignancy that is progressing or has required active treatment within the last 3 years
• •Has had a myocardial infarction within 6 months of randomization/allocation
• •Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
• •Has received prior treatment with a cancer vaccine
• •Has immunodeficiency or is receiving chronic systemic steroid therapy
• •Has active autoimmune disease that has required systemic treatment in the last 2 years
• •Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU)
• •Cohort A:
• •Has current active tuberculosis
• •Has a known history of HIV infection
• •Cohort B:
• •\- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease