Intismeran and BCG for High-Risk Bladder Cancer

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.
Ready to participate?

Review the details below, then apply to join this clinical 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
Who this trial is looking for

This trial is looking for people with high-risk non-muscle invasive bladder cancer. Participants will receive Intismeran along with the standard treatment BCG to see if it helps improve outcomes.

Are You a Good Fit for This Trial?
Rules you out Active tuberculosisKaposi's sarcomaMulticentric Castleman's Disease

You may be able to join if

  • I have high-risk non-muscle invasive bladder cancer
  • I have had a recent bladder tumor removal procedure
  • I have never received BCG treatment or last received it over 2 years ago
  • I have carcinoma in situ or similar conditions
  • I am not receiving another type of bladder therapy
  • I have well controlled HIV if I am HIV positive

You may not be able to join if

  • I have had advanced or metastatic bladder cancer
  • I have had another type of cancer that needs treatment in the last 3 years
  • I had a heart attack in the past 6 months
  • I have received other cancer treatments in the past 4 weeks
  • I have a history of active autoimmune disease requiring treatment
  • I cannot have required imaging tests due to medical reasons

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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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…
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