Clinical trial · Interventional
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma in Situ | Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Non-Muscle Invasive Bladder Neoplasms | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCG | Biological | — | UNRESOLVED |
| Intismeran autogene | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Intismeran autogene + BCG
- description
- Participants in Cohort A receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. Participants also receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.
- interventionNames
- Biological: Intismeran autogene
- Biological: BCG
- type
- ACTIVE_COMPARATOR
- label
- BCG
- description
- Participants in Cohort A receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75
- interventionNames
- Biological: BCG
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available