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New treatment option for Urinary Bladder Neoplasms
Official title A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
ClinicalTrials.gov ID: NCT06833073
What this study is testing
What is Intismeran autogene?
Intismeran autogene is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for urinary bladder neoplasms.
Also referred to as mRNA-4157, V940.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main include but are not limited to the following: \- Is an individual whose most recent TURBT was performed within 12 weeks before...
- Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
- Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must...
- Has CIS +/-papillary non-muscle invasive UC of the bladder
- Is ineligible for, or refusing, any IVESIC therapy
You likely can't join if
- 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 metastatic UC
- Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that...
- Has a known additional malignancy 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 randomization/allocation
See the full eligibility criteria
- The main 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 BICR-confirmed high-risk NMIBC histology Cohort...
- Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
- Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of...
- Has CIS +/-papillary non-muscle invasive UC of the bladder
- Is ineligible for, or refusing, any IVESIC therapy
- Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG
- Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)
- 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 metastatic UC
- Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions
- Has a known additional malignancy 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 randomization/allocation
- Has received prior treatment with a cancer vaccine
- Has immunodeficiency or is receiving chronic systemic steroid therapy
- Has active autoimmune disease that has required systemic treatment in the last 2 years
- Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU) Cohort A:
- Has current active tuberculosis
- Has a known history of HIV infection Cohort B: \- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Torrance, California, United States
- Littleton, Colorado, United States
- Hialeah, Florida, United States
- Chicago Ridge, Illinois, United States
- Lafayette, Louisiana, United States
- Columbia, Missouri, United States
- Lincoln, Nebraska, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Bala-Cynwyd, Pennsylvania, United States
- Germantown, Tennessee, United States
- Austin, Texas, United States
- Virginia Beach, Virginia, United States
- Seattle, Washington, United States
- CABA, Buenos Aires, Argentina
- Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
+ 61 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; Los Alamitos, California, United States; Los Angeles, California, United States; Torrance, California, United States; Littleton, Colorado, United States; Hialeah, Florida, United States and 75 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.