Urinary Bladder Neoplasms study: Intismeran autogene vs BCG
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?
This is an investigational injectable medicine being studied as a potential treatment for high-risk non-muscle invasive bladder cancer. It is designed to help a person's immune system attack their specific cancer.
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
- This study is testing whether the combination of V940 and BCG can keep high‑risk bladder cancer from coming back or spreading, compared to BCG alone.
- Who it's for
- You may be able to join if you have high‑risk non‑muscle invasive bladder cancer, including carcinoma in situ, after your tumor has been removed.
- What's involved
- You will receive the standard tumor removal surgery and then the usual BCG treatment. In the study group, you will also get V940, a new therapy that trains your immune system to fight the cancer. You will have regular check‑ups and tests to see how you are doing.
- Time commitment
- The study lasts about 12 months, with visits at the start, after treatment, and at several follow‑up appointments.
- 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
- Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
- 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...
- Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)
You likely can't join if
- 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
- Has received prior treatment with a cancer vaccine
See the full eligibility criteria
- Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
- 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)
- 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 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 is enrolling
- Bakersfield, 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
- Mar del Plata, Buenos Aires, Argentina
+ 56 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, but 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?
This study is enrolling now at Bakersfield, 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 and 70 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.