NCT06833073

A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Urinary Bladder Neoplasms
• Non-Muscle Invasive Bladder Neoplasms
• Carcinoma in Situ

Interventions

Type	Name	Description
BIOLOGICAL	Intismeran autogene	IM injection
BIOLOGICAL	BCG	Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.

Timeline

• Start date: 2025-03-11
• Primary completion: 2031-09-03
• Completion: 2031-09-03
• First posted: 2025-02-18
• Last updated: 2026-04-06

Locations

89 sites across 19 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Peru, Poland, Spain, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study