Home › Trials › NCT06833073

New treatment for high-risk non-muscle invasive bladder cancer

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)

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT06833073

This study is testing a new treatment combining Intismeran autogene with BCG to see if it can help people with high-risk non-muscle invasive bladder cancer who haven't responded to standard BCG therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment308 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionsimmunotherapy
Locations89 sites (Bakersfield, California and 88 other locations)
Trial IDNCT06833073 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the effectiveness of Intismeran autogene (V940) combined with Bacillus Calmette-Guerin (BCG) in treating patients with high-risk non-muscle invasive bladder cancer (HR NMIBC). The study aims to provide an alternative treatment option for patients whose cancer has not responded to standard BCG therapy. Participants will be selected based on specific criteria, including recent tumor removal and BCG treatment history. The study will assess the safety and efficacy of this new combination therapy in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals with high-risk non-muscle invasive bladder cancer who are either BCG-naïve or have not received adequate BCG treatment in the past two years.

Not a fit: Patients with muscle-invasive bladder cancer or those who have received adequate BCG treatment within the last two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with high-risk non-muscle invasive bladder cancer who do not respond to standard therapies.

How similar studies have performed: Other studies have explored similar immunotherapy approaches, but the combination of Intismeran autogene with BCG is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Bakersfield, California and 88 other locations

+39 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder NeoplasmsCarcinoma in Situ
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.