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

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• Is an individual whose most recent TURBT was performed within 12 weeks beforerandomization/allocation and showed BICR-confirmed high-risk NMIBC histology

BCG Arms:

• Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder

• Is BCG-naïve defined as either having never received BCG or having received BCG morethan 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG

Intismeran autogene Monotherapy Arm:

• Has CIS +/-papillary non-muscle invasive UC of the bladder

• Is ineligible for, or refusing, any IVESIC therapy

• Is either BCG-naïve (as defined above) or BCG-exposed but did not receiveprotocol-specified minimum dosing of BCG and experienced recurrence of high-riskNMIBC within 2 years of the last dose of BCG

• Human immunodeficiency virus (HIV)-infected individuals must have well controlledHIV on antiretroviral therapy (ART)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• 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 invasiveUC 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 activetreatment 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 2years

• Has any contraindication to IV contrast and gadolinium or is otherwise unable tohave imaging with either computerized tomography urogram (CTU) or Magnetic resonanceurography (MRU)

BCG Arms:

• Has current active tuberculosis

• Has a known history of HIV infection

Intismeran autogene Monotherapy Arm:

• HIV-infected individuals with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease