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Study on Mycobacterium Bovis Bacillus Calmette-Guérin for High-risk Non-muscle Invasive Bladder Cancer Patients

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying high-risk non-muscle invasive bladder cancer, a type of bladder cancer that has not spread into the muscle layer of the bladder but is considered high-risk due to its potential to progress. The treatment being tested is called IMUNO BCG Moreau RJ, which is a type of vaccine made from a live strain of bacteria known as Mycobacterium bovis Bacillus Calmette-Guérin, strain Moreau Rio de Janeiro. This treatment is used as a prophylactic, meaning it is intended to prevent the cancer from progressing further.

The purpose of the study is to assess how well patients with this type of bladder cancer respond to the treatment in terms of progression-free survival, which means the length of time during and after treatment that the patient lives with the disease without it getting worse. Participants in the study will receive the treatment through a method called intravesical use, where the solution is directly instilled into the bladder. The study will monitor patients over a period of time to see how the cancer responds to the treatment and to evaluate any side effects or adverse reactions that may occur.

Throughout the study, various aspects will be observed, including the rate at which the cancer progresses at 12 and 24 months, the overall survival without disease recurrence, and the quality of life of the participants. The study will also look at the body's immune response to the treatment by analyzing certain proteins in the urine. This trial aims to provide valuable information on the effectiveness and safety of IMUNO BCG Moreau RJ in preventing the progression of high-risk non-muscle invasive bladder cancer.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the first step involves signing the informed consent. This document confirms understanding of the study and agreement to participate. It is signed before any study-related activities begin.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility. This includes verifying age between 18 and 85 years, diagnosis of a high-risk non-muscle invasive bladder tumor, and a risk of recurrence or progression as per specific criteria.

  3. Step 3

    Treatment initiation

    The treatment involves the use of IMUNO BCG Moreau RJ, a medication administered through intravesical use. This means the medication is placed directly into the bladder.

  4. Step 4

    Treatment schedule

    The treatment schedule includes regular instillations of the medication. The exact dosage, frequency, and duration of administration are determined by the study protocol and communicated during the trial.

  5. Step 5

    Follow-up assessments

    Follow-up assessments are conducted to monitor the progression of the condition. These assessments occur at specified intervals, such as 12 months and 24 months after the last tumor resection.

  6. Step 6

    Quality of life evaluation

    Quality of life is evaluated using a questionnaire adapted to the local language. This helps assess the impact of the treatment on daily life and well-being.

  7. Step 7

    Monitoring adverse reactions

    Adverse reactions are monitored throughout the study. Any side effects experienced are recorded and assessed for severity and frequency.

  8. Step 8

    Immunological response analysis

    The study includes analysis of the body's immune response. This involves testing urine samples at specific visits to measure certain immune markers.

  9. Step 9

    Completion of study

    The study concludes after the final follow-up assessments. The overall effectiveness of the treatment is evaluated based on the collected data.

Who can join the trial?

5 criteria

  • Sign the informed consent form before any study-related activities begin. This means you agree to participate after understanding the study details.
  • Be between 18 and 85 years old at the time of signing the informed consent.
  • Have a urothelial tumor, which is a type of bladder cancer.
  • Have a high-risk non-muscle invasive bladder tumor. This is defined as a tumor that is classified as Ta-T1 and GIIb or GIII, either newly diagnosed or returned, with or without associated carcinoma in situ (a type of cancer that is in its original place).
  • Have a risk of cancer coming back or getting worse that is greater than or equal to 7 points, according to the CUETO tables, which is a system used to assess risk levels.

Who cannot join the trial?

9 criteria

  • Patients who have had a different type of cancer in the past 5 years, except for skin cancer that is not melanoma.
  • Patients who have an active infection that requires treatment with antibiotics.
  • Patients who have a known allergy to BCG (Bacillus Calmette-Guérin), which is a type of bacteria used in the treatment.
  • Patients who have a weakened immune system, which means their body has a reduced ability to fight infections and diseases.
  • Patients who are currently receiving treatment with another investigational drug, which means a drug that is still being studied and is not yet approved for general use.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had major surgery within the last 4 weeks.
  • Patients who have a history of drug or alcohol abuse within the past 2 years.
  • Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

IMUNO BCG Moreau RJ is a type of therapy used to treat bladder cancer. It involves using a special kind of bacteria that has been weakened so it doesn't cause disease. This therapy is placed directly into the bladder through a catheter. The goal is to stimulate the body's immune system to attack cancer cells in the bladder. This treatment is often used for patients with high-risk non-muscle invasive bladder cancer to help prevent the cancer from coming back or getting worse.

What is already known about the treatment

IMUNO BCG Moreau RJ – This medication is administered directly into the bladder through a catheter, a method known as intravesical therapy. It is currently being studied for its effectiveness in treating high-risk non-muscle invasive bladder cancer, with a focus on preventing cancer progression. The main therapeutic use of IMUNO BCG Moreau RJ is to reduce the risk of bladder cancer returning or worsening. At the molecular level, it works by stimulating the immune system to attack cancer cells in the bladder. It is classified as an immunotherapy, which means it uses the body's own immune system to help fight cancer.

Investigated diseases

High-risk Non-muscle Invasive Bladder Cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not yet invaded the muscle layer. It is considered high-risk due to factors such as tumor size, grade, and recurrence rate, which increase the likelihood of progression. The disease often begins with symptoms like blood in the urine, frequent urination, and pain during urination. Over time, if not managed, the cancer can progress to invade deeper layers of the bladder wall. The progression is typically monitored using the TNM classification system, which assesses tumor size, lymph node involvement, and metastasis. Regular follow-ups are crucial to detect any changes in the tumor's behavior.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519288-17-00Protocol codeENCORE-01Estimated enrolment306 patientsSponsorBiofabri S.L.

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