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A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
NCT06833073 · View on ClinicalTrials.gov ↗
Study 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 to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder. The standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.
Conditions Studied
Interventions
- BIOLOGICAL Intismeran autogene
- BIOLOGICAL BCG
Study Locations (20)
California
- Michael G Oefelein Clinical Trials ( Site 0138) — Bakersfield
- Genesis Research, LLC ( Site 0141) — Los Alamitos
- USC Norris Comprehensive Cancer Center ( Site 0123) — Los Angeles
- Genesis Healthcare-Torrance ( Site 0140) — Torrance
- Genesis Research LLC ( Site 0118) — Torrance
Texas
- Texas Oncology-Austin Central ( Site 0107) — Austin
- Urology Austin, PLLC ( Site 0109) — Austin
Colorado
- Urology Associates ( Site 0144) — Littleton
Florida
- Urological Research Network ( Site 0133) — Hialeah
Illinois
- Associated Urological Specialists - Chicago Ridge ( Site 0139) — Chicago Ridge
Louisiana
- Southern Urology, LLC ( Site 0145) — Lafayette
Missouri
- University of Missouri Health Care ( Site 0126) — Columbia
Nebraska
- NHO Revive Research Institute, LLC ( Site 0137) — Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2025-03-11 |
| Est. Completion | 2031-09-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06833073
The ClinicalTrials.gov registry entry for NCT06833073 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Urinary Bladder Neoplasms appearing as the primary indexed condition, and to 2 interventions — of which Intismeran autogene is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06833073 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Texas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06833073 about?
NCT06833073 is a clinical study titled "A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)". 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 to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of ge...
What is the current status of trial NCT06833073?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 308 participants. The study started on 2025-03-11. Estimated completion is 2031-09-03.
What conditions does trial NCT06833073 study?
This clinical trial studies the following conditions: Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06833073?
The interventions under investigation include: Intismeran autogene (BIOLOGICAL), BCG (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06833073?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06833073 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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