Last updated 13 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

Merck Sharp & Dohme LLC

2Research sites

308Patients around the world

This study is for people with

Bladder Cancer

Non-muscle-invasive bladder cancer

From 18 Years

All Gender

: Is an individual whose most recent TURBT was performed within 12 weeks before randomization/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 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.
V940 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 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).

: 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).
BCG Arms:
Has current active tuberculosis.
Has a known history of HIV infection.
V940 Monotherapy Arm:: HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.

Instituto de Investigaciones Clínicas Mar del Plata

Recruiting

Av. Colón 3456, Mar del Plata, Buenos Aires

Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires

Recruiting

Campana 4658, CABA, Buenos Aires

SponsorMerck Sharp & Dohme LLC

Study typeInterventional

Conditions

Non-muscle-invasive bladder cancer

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06833073