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Looking for participantsPhase2

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06833073

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Intismeran autogene (biological), BCG (biological)
How long the study runs
Study runs about 78 months (dates as stated)
About the drug or intervention
Intismeran autogene — biological: IM injection · BCG — biological: Intravesicular instillation.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
308
Started
2025-03-11
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for urinary bladder neoplasms
  • • Phase2 - 308 participants
  • • Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with urinary bladder neoplasms

Where?

  • • Glasgow - Gartnavel General Hospital ( Site 1702)
  • • London - St Bartholomew s Hospital ( Site 1700)
  • • Torquay - Torbay Hospital ( Site 1701)

This is a simplified summary. Always discuss with your doctor before making any decisions.

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 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.

More detail

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.

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder NeoplasmsCarcinoma in Situ

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ well controlled HIV on antiretroviral therapy (ART)

What the study is looking for

  • ✓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...
  • ✓Cohort A:
  • ✓Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
  • ✓Cohort B:

Who cannot take part

  • ✗The main exclusion criteria include but are not limited to the following:
  • ✗Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or that has spread UC
  • ✗Has a known additional cancer that is progressing or has required active treatment within the last 3 years
  • ✗Has had a myocardial infarction within 6 months of randomization/allocation
  • ✗Has received any systemic anticancer therapy including investigational agents within 4 weeks before...
See the full 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 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 must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG Cohort B: * Has CIS +/-papillary non-muscle invasive UC of the bladder * Is ineligible for, or refusing, any IVESIC therapy * Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG * Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC * Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions * Has a known additional malignancy that is progressing or has required active treatment within the last 3 years * Has had a myocardial infarction within 6 months of randomization/allocation * Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation * Has received prior treatment with a cancer vaccine * Has immunodeficiency or is receiving chronic systemic steroid therapy * Has active autoimmune disease that has required systemic treatment in the last 2 years * Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU) Cohort A: * Has current active tuberculosis * Has a known history of HIV infection Cohort B: \- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Where Is This Study? (3 UK sites)

Gartnavel General Hospital ( Site 1702)

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441413017000

St Bartholomew s Hospital ( Site 1700)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4402073777000

Torbay Hospital ( Site 1701)

Torquay TQ2 7AA, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441803614567

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09