Last updated 5 days ago
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
308 patients around the world
Available in Argentina, United States
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.
Merck Sharp & Dohme LLC
24Research sites
308Patients around the world
This study is for people with
Bladder Cancer
Non-muscle-invasive bladder cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.Cohort A: 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.Cohort B: Is ineligible for, or refusing, any IVESIC therapy.Cohort B: 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.Cohort B: Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART).
- 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.Cohort A: 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.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Recruiting
Sanatorio Parque - Rosario
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital de Clínicas de Passo Fundo
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Non-muscle-invasive bladder cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06833073
