A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Recruiting
Phase 2
Interventional Study
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Carcinoma in Situ
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 308 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
The main inclusion criteria 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 A:
* Has high-risk non-muscle invasiv…
Contacts