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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Michael G Oefelein Clinical Trials ( Site 0138)
  Bakersfield, California, United States Recruiting
• USC Norris Comprehensive Cancer Center ( Site 0123)
  Los Angeles, California, United States Recruiting
• Genesis Healthcare-Torrance ( Site 0140)
  Torrance, California, United States Recruiting
• Genesis Research LLC ( Site 0118)
  Torrance, California, United States Recruiting
• Urology Associates ( Site 0144)
  Littleton, Colorado, United States Recruiting
• Urological Research Network ( Site 0133)
  Hialeah, Florida, United States Recruiting

+39 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inactivated UPEC-FimON for Bladder Cancer After BCG or Intravesical Therapy Failure

  This phase 1 study tests whether intravesical doses of inactivated UPEC-FimON are safe and tolerable in adults with non-muscle invasive bladder cancer that progressed after BCG or intravesical therapy.

  Recruiting at 3 sites Phase 1 Hopec Pharma · Kfar Saba, Central District and 2 other locations · NCT07881666

• Alpha1H before bladder tumor surgery in low/intermediate risk non-muscle-invasive bladder cancer

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• Understanding how high-risk non-muscle-invasive bladder cancer is diagnosed and cared for in Portugal

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  Recruiting Janssen-Cilag Farmaceutica Ltda. · Lisbon · NCT07784387

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  Recruiting Assistance Publique - Hôpitaux de Paris · Boulogne-Billancourt and 4 other locations · NCT07739121

• Real-world look at high-risk non-muscle-invasive bladder cancer after BCG in Korea

  This study tests how people with high-risk non-muscle-invasive bladder cancer fare after BCG therapy in real-world clinical settings in Korea.

  Recruiting Janssen Korea, Ltd., Korea · Suwon · NCT07735793

• Enfortumab vedotin plus pembrolizumab versus chemoradiotherapy for muscle-invasive bladder cancer

  This trial tests whether combining enfortumab vedotin with pembrolizumab can help people with non-metastatic muscle-invasive bladder cancer keep their bladder and control the cancer better than standard concurrent chemoradiotherapy.

  Recruiting at 29 sites Phase 3 Astellas Pharma Inc · Little Rock, Arkansas and 28 other locations · NCT07566156

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.