As of Amendment 03 (effective 01/05/2026), outcome measures associated with the Intismeran autogene Monotherapy Arm (Cohort B) are no longer considered primary or secondary outcome measures.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\- Is an individual whose most recent TURBT was performed within 12 weeks before randomization/allocation and showed BICR-confirmed high-risk NMIBC histology
Cohort A:
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 more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG
Cohort B:
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 receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG
Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)
You may not be if
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
