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Clinical Study of Intismeran Autogene and BCG for Bladder Cancer

This study is looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). This type of cancer is in the lining of your bladder but hasn't spread to the muscle. "High-risk" means it might have a higher chance of getting worse or coming back. The study is testing a new treatment called Intismeran autogene along with the standard treatment, BCG (Bacillus Calmette-Guerin). You may be able to join if you are an adult with HR NMIBC that has not been treated with BCG before, and your tumor was recently removed. The main goal is to see how long people live without the cancer returning or getting worse (Event-free Survival) for up to about 5 years.

Study design
This is an interventional study with a planned enrollment of 308 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Event-free Survival for up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06833073

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~308 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Intismeran autogeneBCG

At a glance

Recruiting sites
85 of 89 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort A: Event-free Survival (EFS)
Measured over Up to approximately 5 years

Conditions

Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Carcinoma in Situ

Explore related trials

Carcinoma In SituNon-Muscle Invasive Bladder Carcinoma

NCT06833073

Where you'd take part

This study runs at 89 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)

    Buenos Aires, Buenos Aires F.D., Argentinastudy coordinator listed

    Recruiting

  • Associated Urological Specialists - Chicago Ridge ( Site 0139)

    Chicago Ridge, Illinoisstudy coordinator listed

    Recruiting

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)

    Chaidari/Athens, Attica, Greecestudy coordinator listed

    Recruiting

  • Azienda USL 8 di Arezzo ( Site 1203)

    Arezzo, Italystudy coordinator listed

    Recruiting

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)

    Dusit, Bangkok, Thailandstudy coordinator listed

    Recruiting

  • Bordeaux University Hospital - Pellegrin ( Site 0806)

    Bordeaux, Gironde, Francestudy coordinator listed

    Recruiting

  • Bradford Hill Norte ( Site 0503)

    Antofagasta, Chilestudy coordinator listed

    Recruiting

  • Bradfordhill ( Site 0501)

    Santiago, Region M. de Santiago, Chilestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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
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

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)
Has current active tuberculosis
Has a known history of HIV infection

What this trial measures

  • Cohort A: Event-free Survival (EFS)Up to approximately 5 years

    EFS is defined as the time from randomization to any of the following events, as determined by blinded independent central review (BICR): High-grade (HG) non-invasive papillary carcinoma (Ta) or carcinoma in situ (CIS) in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of urothelial carcinoma (UC); High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC \[defined as regional lymph node metastasis of UC (stage N1 or greater), or distant metastasis of UC including non-regional lymph nodes (stage M1)\]; Or death due to any cause. The EFS for BCG-treated participants will be presented.