A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517335-46-00

Acronym

V940-011

Enrollment

138

Registered

2025-04-23

Start date

2025-06-05

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Brief summary

Cohort A: Event-Free Survival (EFS), Cohort B: Complete Response Rate (CRR)

Detailed description

Cohort A: 12-month EFS Rate, Cohort A: 24-month EFS Rate, Cohort A: Recurrence-Free Survival (RFS), Cohort A: Disease-Specific Survival (DSS), Cohort A: Overall Survival (OS), Cohort A: 12-month OS Rate, Cohort A: 24-month OS Rate, Cohort A: CRR, Cohort A: Duration of Response (DOR), Cohort A: Time to Cystectomy, Cohort B: 6-month CRR, Cohort B: 12-month CRR, Cohort B: RFS, Cohort B: DSS, Cohort B: OS, Cohort B: Time to Cystectomy, Number of Participants who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Interventions

DRUGmRNA-4157

DRUGBCG VACCINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Cohort A: 12-month EFS Rate, Cohort A: 24-month EFS Rate, Cohort A: Recurrence-Free Survival (RFS), Cohort A: Disease-Specific Survival (DSS), Cohort A: Overall Survival (OS), Cohort A: 12-month OS Rate, Cohort A: 24-month OS Rate, Cohort A: CRR, Cohort A: Duration of Response (DOR), Cohort A: Time to Cystectomy, Cohort B: 6-month CRR, Cohort B: 12-month CRR, Cohort B: RFS, Cohort B: DSS, Cohort B: OS, Cohort B: Time to Cystectomy, Number of Participants who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE	—

Measure

Time frame

—

Primary

Measure	Time frame
Cohort A: Event-Free Survival (EFS), Cohort B: Complete Response Rate (CRR)	—

Countries

Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026