At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Intismeran autogene (biological), BCG (biological)
- How long the study runs
- Study runs about 78 months (dates as stated)
- About the drug or intervention
- Intismeran autogene — biological: IM injection · BCG — biological: Intravesicular instillation.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 308
- Started
- 2025-03-11
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for urinary bladder neoplasms
- • Phase2 - 308 participants
- • Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with urinary bladder neoplasms
Where?
- • Glasgow - Gartnavel General Hospital ( Site 1702)
- • London - St Bartholomew s Hospital ( Site 1700)
- • Torquay - Torbay Hospital ( Site 1701)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ well controlled HIV on antiretroviral therapy (ART)
What the study is looking for
- ✓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...
- ✓Cohort A:
- ✓Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
- ✓Cohort B:
Who cannot take part
- ✗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 that has spread UC
- ✗Has a known additional cancer 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...
See the full criteria
Where Is This Study? (3 UK sites)
Gartnavel General Hospital ( Site 1702)
Glasgow G12 0YN, United Kingdom
St Bartholomew s Hospital ( Site 1700)
London EC1A 7BE, United Kingdom
Torbay Hospital ( Site 1701)
Torquay TQ2 7AA, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
