Actively Recruiting
A Study of Intismeran Autogene V940 With BCG Compared to BCG Alone in People With High-risk Non-muscle Invasive Bladder Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-28
308
Participants Needed
89
Research Sites
N/A
Total Duration
On this page
Sponsors
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Merck Sharp & Dohme LLC
Lead Sponsor
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ModernaTX, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new treatment options for people with high-risk non-muscle invasive bladder cancer HR NMIBC, a type of bladder cancer that affects the inner lining of the bladder but has not spread to the muscle or beyond. This includes carcinoma in situ CIS, a flat form of bladder cancer limited to the bladders surface. The study aims to find out if adding intismeran autogene, an immune system-targeting treatment, to the standard Bacillus Calmette-Guerin BCG therapy can improve outcomes for people with HR NMIBC by helping the immune system attack the cancer more effectively. Participants are assigned to different groups. One group receives both intismeran autogene by intramuscular injection every three weeks for nine doses along with BCG treatment given once weekly for six weeks, followed by additional weekly doses at later weeks. Another group receives BCG alone on the same schedule, while a third group receives only intismeran autogene. The study compares these treatments to see if the combination improves survival without cancer growth, spread, or return. During the study, participants will be monitored for up to approximately five years to track event-free survival, recurrence-free survival, overall survival, and other outcomes. Researchers will also evaluate adverse events and treatment tolerability. Follow-up includes assessments at regular intervals to observe disease status and safety. The total participation time may last several years to gather long-term data on treatment effects.
CONDITIONS
Brief Title
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Most recent tumor removal by TURBT within 12 weeks before randomization with confirmed high-risk non-muscle invasive bladder cancer
- For Cohort A: High-risk non-muscle invasive urothelial carcinoma (HG Ta, T1, and/or CIS) of the bladder
- BCG-nafve for Cohort A, defined as never having received BCG or last BCG more than 2 years before recurrence with complete response during that period
- For Cohort B: CIS with or without papillary non-muscle invasive urothelial carcinoma
- Ineligible for or refusing any intravesical therapy for Cohort B
- BCG-nafve or BCG-exposed but with incomplete dosing and recurrence within 2 years for Cohort B
- HIV-infected individuals must have well-controlled HIV on antiretroviral therapy
You will not qualify if you...
- History or current locally advanced or metastatic urothelial carcinoma
- Concurrent or recent extravesical non-muscle invasive urothelial carcinoma within 2 years, with exceptions
- Additional malignancy progressing or treated within last 3 years
- Myocardial infarction within 6 months before randomization
- Systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Prior cancer vaccine treatment
- Immunodeficiency or chronic systemic steroid therapy
- Active autoimmune disease requiring systemic treatment in last 2 years
- Contraindication to intravenous contrast or gadolinium or inability to undergo CT or MR urography
- For Cohort A: Active tuberculosis or known HIV infection
- For Cohort B: HIV-infected individuals with history of Kaposi's sarcoma or Multicentric Castleman's Disease
Research Team
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