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NCT06833073 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
A Phase 2 study of Urinary Bladder Neoplasms and Non-Muscle Invasive Bladder Neoplasms, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 308
- Enrollment target
- 20
- Study locations
NCT06833073: Recruiting Phase 2 study of Urinary Bladder Neoplasms and Non-Muscle Invasive Bladder Neoplasms, sponsored by Merck Sharp & Dohme.
NCT06833073 is a Phase 2 study of Urinary Bladder Neoplasms and Non-Muscle Invasive Bladder Neoplasms that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 308 participants, roughly in line with the 297-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06833073, a Phase 2 study of Urinary Bladder Neoplasms and Non-Muscle Invasive Bladder Neoplasms, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 308 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
EFS is defined as the time from randomization to any of the following events, as determined by blinded independent central review (BICR): High-grade (HG) non-invasive papillary carcinoma (Ta) or carcinoma in situ (CIS) in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of urothelial carcinoma (UC); High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tr
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 |
What NCT06833073 shows while recruiting
NCT06833073 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 297-participant average among 19 other Urinary Bladder Neoplasms trials with a reported enrollment target.
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.
NCT06833073 names 20 study sites across 15 states, led by California, Texas, Colorado.
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.
What interventions are being tested in trial NCT06833073?
The interventions under investigation include: Intismeran autogene (BIOLOGICAL), BCG (BIOLOGICAL).
Who is sponsoring clinical trial NCT06833073?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06833073's enrollment target sits among peer trials
308 9th of 19 higher than 11 of 19 other Urinary Bladder Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Bladder Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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