Status:
RECRUITING
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
ModernaTX, Inc.
Conditions:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 3 2031
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT06833073
Start Date
March 11 2025
End Date
September 3 2031
Last Update
February 19 2026
Active Locations (89)
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1
Michael G Oefelein Clinical Trials ( Site 0138)
Bakersfield, California, United States, 93301
2
Genesis Research, LLC ( Site 0141)
Los Alamitos, California, United States, 90720
3
USC Norris Comprehensive Cancer Center ( Site 0123)
Los Angeles, California, United States, 90033
4
Genesis Healthcare-Torrance ( Site 0140)
Torrance, California, United States, 90503