A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06833073
This study evaluates intismeran autogene, an IM injection, with BCG, an intravesicular instillation, in HR NMIBC. Eligible participants include those with recent TURBT-confirmed HR NMIBC. BCG arms require BCG-naïve status or a 2-year gap post-BCG. The intismeran monotherapy arm includes CIS patients ineligible for IVESIC therapy, with specific BCG exposure criteria.
Patient Parameters
| Parameter | Options |
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Program Overview
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 goals of this study are to learn:
- If people who receive intismeran autogene with BCG live longer without the cancer growing, spreading, or coming back, or dying from any cause, compared to people who receive BCG alone
- If more people who receive intismeran autogene with BCG have their cancer go away (complete response), compared to people who receive BCG alone
- How many people who receive intismeran autogene without BCG have their cancer go away
Eligibility 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
BCG Arms:
- 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
Intismeran autogene Monotherapy Arm:
- 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)
BCG Arms:
- Has current active tuberculosis
- Has a known history of HIV infection
Intismeran autogene Monotherapy Arm:
- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Michael G Oefelein Clinical Trials ( Site 0138) | 93301 | Bakersfield | California |
| Los Alamitos Hematology Oncology Medical Group ( Site 0141) | 90720 | Los Alamitos | California |
| Genesis Healthcare-Torrance ( Site 0140) | 90503 | Torrance | California |
| Genesis Research LLC ( Site 0118) | 90505 | Torrance | California |
| Urological Research Network ( Site 0133) | 33016 | Hialeah | Florida |
| University of Missouri Health Care ( Site 0126) | 65212 | Columbia | Missouri |
| NHO Revive Research Institute, LLC ( Site 0137) | 68506 | Lincoln | Nebraska |
| OHSU Knight Cancer Institute - South Waterfront ( Site 0110) | 97239 | Portland | Oregon |
| Urology Austin, PLLC ( Site 0109) | 78759 | Austin | Texas |
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