A clinical study of V940 and BCG in people with bladder cancer (V940-011)
EU CTIS ID: 2024-517335-46-00
What this study is testing
Cohort A: To compare V940 in combination with BCG to BCG monotherapy with respect to EFS
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before randomization/allocation and showed centrally-confirmed high-risk non-muscle invasive bladder cancer (NMIBC)
- Cohort A: Is BCG-naïve defined as either having never received Bacillus Calmette–Guérin (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 complete response during the 2-year period post BCG
- Cohort B: Is either BCG-naïve (as defined above) or BCG-exposed who did not receive adequate dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG
- Is an individual who can provide a tumor tissue sample that is suitable for the NGS and provide blood samples as specified in the study
- Is an individual with a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 56 days before randomization/allocation
- Cohort B only: 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 or metastatic urothelial carcinoma (UC)
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization/allocation
- Active autoimmune disease that has required systemic treatment in the last 2 years
- Active infection and/or diagnosis requiring systemic therapy at the time of randomization/allocation
- Cohort A only: Has a history of a hypersensitivity reaction to V940 and/or BCG and/or any of their excipients. Cohort B only: Has a history of a hypersensitivity reaction to V940 and/or any of its excipients
- Has not adequately recovered from major surgery or has ongoing surgical complications
See the full eligibility criteria
Who can join
- Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before randomization/allocation and showed centrally-confirmed high-risk non-muscle invasive bladder cancer (NMIBC)
- Cohort A: Is BCG-naïve defined as either having never received Bacillus Calmette–Guérin (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 complete response during the 2-year period post BCG
- Cohort B: Is either BCG-naïve (as defined above) or BCG-exposed who did not receive adequate dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG
- Is an individual who can provide a tumor tissue sample that is suitable for the NGS and provide blood samples as specified in the study
- Is an individual with a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 56 days before randomization/allocation
- Cohort B only: Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)
- Individuals who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization/allocation
What rules you out
- Has a history of or concurrent locally-advanced or metastatic urothelial carcinoma (UC)
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization/allocation
- Active autoimmune disease that has required systemic treatment in the last 2 years
- Active infection and/or diagnosis requiring systemic therapy at the time of randomization/allocation
- Cohort A only: Has a history of a hypersensitivity reaction to V940 and/or BCG and/or any of their excipients. Cohort B only: Has a history of a hypersensitivity reaction to V940 and/or any of its excipients
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Is incapacitated
- Cohort A only: Has one or more of the following contraindications to BCG: prior BCG sepsis or systemic infection, total bladder incontinence, or an adverse experience to a previous BCG instillation that resulted in treatment discontinuation and precludes retreating with BCG
- Cohort A only: Has current active tuberculosis
- Has concurrent extravesical non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years
- Has a known additional malignancy that is progressing or has required active treatment within the last 3 years
- Had a myocardial infarction within 6 months of randomization/allocation
- Cohort A only: Has a known history of HIV infection
- Cohort B only: Is HIV-infected individual with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has received prior treatment with a cancer vaccine
The study team makes the final eligibility decision.
Where it's taking place
- Italy
- Germany
- Denmark
- Poland
- Spain
- France
- Greece
- Netherlands
- Hungary
- Argentina
- Brazil
- Canada
- Thailand
- Chile
- United States
- Australia
- Colombia
- Peru
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Italy; Germany; Denmark; Poland; Spain; France and 13 more locations. Enter your location above to see the nearest 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 EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.