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

Launched by MERCK SHARP & DOHME LLC · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial, called V940-011, is exploring a new treatment approach for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), which is a type of bladder cancer that hasn't spread to the bladder muscle but has a higher chance of getting worse or coming back. The current standard treatment involves removing the tumor through a procedure and then using an immunotherapy called Bacillus Calmette-Guerin (BCG) to help the body’s immune system fight the cancer. However, BCG doesn’t work for everyone, and this study aims to see if adding a new treatment called V940 to BCG can improve outcomes. Researchers want to find out if this combination helps patients live longer without their cancer worsening or returning and if it leads to more patients achieving complete cancer-free status.

To be eligible for the trial, participants need to have had a recent bladder tumor removal and confirmed high-risk NMIBC. They must be either new to BCG treatment or have had it more than two years ago. The study is open to adults aged 65 to 74, and those with well-controlled HIV can also participate. If you join the study, you will either receive the combination of V940 and BCG or just BCG alone. Throughout the trial, participants will have regular check-ups to monitor their health and response to the treatment. This trial is currently recruiting, so it might be a good opportunity for those looking for new treatment options.

Gender

ALL

Eligibility criteria

• 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 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
• 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 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)
• 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 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
• Intismeran autogene Monotherapy Arm:
• • - HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease