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

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

Trial Details

NCT ID
NCT06833073
Phase
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Intismeran autogene
  • BCG
Locations (sample)
  • Bakersfield, California, United States|35.37329,-119.01871
  • Los Alamitos, California, United States|33.80307,-118.07256
  • Los Angeles, California, United States|34.05223,-118.24368
  • Torrance, California, United States|33.83585,-118.34063
  • Torrance, California, United States|33.83585,-118.34063

Key Eligibility 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…
  • Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
  • Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence mus…

For full eligibility, visit ClinicalTrials.gov.

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