A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Public ClinicalTrials.gov record NCT06833073. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06833073
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 308 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 10, 2025
- Primary completion
- Sep 2, 2031
- Completion
- Sep 2, 2031
- Last update posted
- Aug 25, 2026
2025 – 2031
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Michael G Oefelein Clinical Trials ( Site 0138) | Bakersfield | California | 93301 | Recruiting |
| Genesis Research, LLC ( Site 0141) | Los Alamitos | California | 90720 | Active, not recruiting |
| USC Norris Comprehensive Cancer Center ( Site 0123) | Los Angeles | California | 90033 | Recruiting |
| Genesis Healthcare-Torrance ( Site 0140) | Torrance | California | 90503 | Recruiting |
| Genesis Research LLC ( Site 0118) | Torrance | California | 90505 | Recruiting |
| Urology Associates ( Site 0144) | Littleton | Colorado | 80122 | Recruiting |
| Urological Research Network ( Site 0133) | Hialeah | Florida | 33016 | Recruiting |
| Associated Urological Specialists - Chicago Ridge ( Site 0139) | Chicago Ridge | Illinois | 60415 | Recruiting |
| Southern Urology, LLC ( Site 0145) | Lafayette | Louisiana | 70508 | Recruiting |
| University of Missouri Health Care ( Site 0126) | Columbia | Missouri | 65212 | Recruiting |
| NHO Revive Research Institute, LLC ( Site 0137) | Lincoln | Nebraska | 68506 | Recruiting |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111) | New York | New York | 10016 | Recruiting |
| TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122) | Cincinnati | Ohio | 45212 | Recruiting |
| OHSU Knight Cancer Institute - South Waterfront ( Site 0110) | Portland | Oregon | 97239 | Recruiting |
| MidLantic Urology ( Site 0102) | Bala-Cynwyd | Pennsylvania | 19004 | Recruiting |
| The Conrad Pearson Clinic ( Site 0143) | Germantown | Tennessee | 38138 | Recruiting |
| Texas Oncology-Austin Central ( Site 0107) | Austin | Texas | 78705 | Recruiting |
| Urology Austin, PLLC ( Site 0109) | Austin | Texas | 78759 | Recruiting |
| Urology of Virginia ( Site 0125) | Virginia Beach | Virginia | 23462 | Recruiting |
| University of Washington - Fred Hutchinson Cancer Center ( Site 0100) | Seattle | Washington | 98195 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06833073, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2026 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06833073 live on ClinicalTrials.gov.