A Phase 2 Study of V940 Plus BCG Versus BCG Monotherapy in High-risk NMIBC

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  1011186

• Contact name

  - -

• Contact email

  -

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06833073

• Research 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 a high chance of NMIBC getting worse or coming back after treatment.
  Standard treatment for HR NMIBC is to remove the tumour called transurethral resection of the bladder tumour (TURBT) followed by Bacillus Calmette-Guerin (BCG). BCG is an immunotherapy, which helps the immune system fight cancer. BCG may not work in some people. Researchers want to learn if adding V940 to standard treatment can help treat HR NMIBC. V940 is designed to help a person’s immune system attack their specific cancer.
  The goals are to learn if, compared to people who receive BCG alone:
  • People who receive V940 with BCG live longer without the cancer growing, spreading, or coming back, or death from any cause
  • More people who receive V940 with BCG have their cancer go away

  About 308 people with HR NMIBC aged 18 years and older will be in this trial and:
  • Had a TURBT within the last 3 months
  • Do not have certain types of cancer

  People will be in 1 of 2 groups:
  • Group 1: Equal chance to get BCG with V940 or BCG alone
  • Group 2: To get V940 alone

  BCG is given directly into the bladder using a tube (once a week) for about 1.5 years. V940 is given as an injection every 3 weeks for about 7 months.

  People will give blood and urine samples, answer questions about how they are feeling, have physical examinations and imaging tests, have a cystoscopy and a biopsy. A person may be in this trial for about 5 years.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  25/SC/0070

• Date of REC Opinion

  30 Apr 2025

• REC opinion

  Further Information Favourable Opinion