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Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03982797
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Fundación para la Investigación en Urología (FIU)
Information provided by (Responsible Party):
Biofabri, S.L

Brief Summary:

Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG *Bacile Calmette-Guérin" as immunotherapy drug.

BCG Moreau strain is not authorized by AEMPS, it was developed in Brazil and this country has extensive experience in treatment of non-muscle invasive bladder cancer with BCG Moreau, also BCG Moreau Rio de Janeiro make same immunological reaction as TICE, but with less adverse events. Thus, BCG Moreau RJ treatment could be used more time than TICE with the same dose, keeping immunologic status and better prophylaxis of recurrence or progression results for the patient.

Each patient will be instillated via transurethral each time with 80 mg of IMUNO BCG Moreau RJ. There are 15 instillations during the clinical trial, 6 instillations on induction phase and 9 will be performed during maintaince phase.

Condition or disease Intervention/treatment Phase
Bladder Cancer Biological: Instillation of IMUNO BCG Moreau RJ Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis of Recurrence and Progression.
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : April 3, 2021
Estimated Study Completion Date : March 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: treated with IMUNO BCG Moreau RJ adjuvant. Biological: Instillation of IMUNO BCG Moreau RJ
Instillation in bladder will be done once per week during first six weeks after inclusion, and 3 instillations (one per week) on month three, another three on moth six and last three on month twelve .

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 24 months ]
    The primary objective is to assessment the progression-free survival of patients diagnosed with high-risk non-muscle invasive bladder tumors treated with IMUNO BCG Moreau RJ adjuvant.

Secondary Outcome Measures :
  1. Disease-free survival. [ Time Frame: 24 months ]
    The secondary objective is to assessment the disease-free survival.

  2. Assessment of the quality of life [ Time Frame: 24 months ]
    Assessment will be measure with FACT-BL version4th

  3. Assessment of adverse reactions [ Time Frame: 24 months ]
    Assessment will be measure in number and relation with IMP

  4. Assessment of the dropout rate due to toxicity [ Time Frame: 24 months ]
    Assessment will be measure in number

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection.
  2. Age between 18 and 80 years at the time of signing the informed consent.
  3. Urothelial tumor.
  4. High risk non-muscle invasive bladder tumor (defined as Ta-T1 and GIIb or GIII) diagnosed de novo or relapsed with or without associated in situ carcinoma. or carcinoma in situ isolated without visible tumor.
  5. Patient with risk of recurrence or progression greater than or equal to 10 points, according to CUETO tables.

Exclusion Criteria:

  1. No muscle layer in pathological examination piece's.
  2. Non-urothelial tumor.
  3. Active cancer in any other location.
  4. Diagnosis of any other pathology that in the opinion of the researcher may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.
  5. Administration of BCG in the last year before signing the informed consent. 6. BCG instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc.

7. Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.

8. Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU).

9. Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent.

10. Woman considered potentially fertile. Following the Clinical Trial Facilitation Group (CTFG) recommendations, a woman is considered childbearing potential (WOCBP), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

11. Patients with difficulties to perform the follow-up visits established in the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03982797

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Contact: Ingrid Murillo, MSc. 0034986330400
Contact: Sara Barja, MSc. 0034986330400

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Hospital Universitario Basurto Active, not recruiting
Bilbao, Spain, 48013
Complejo Hospitalario Puerta Del Mar Active, not recruiting
Cadiz, Spain, 11009
Complexo Hospitalario Universitario A Coruña Not yet recruiting
Coruña, Spain, 15006
Contact: Venancio Chantada Abal, MD   
Principal Investigator: Venancio Chantada Abal, MD         
Complejo Hospitalario Regional Reina Sofía Active, not recruiting
Córdoba, Spain, 14004
Hospital Universitario Virgen de Las Nieves Recruiting
Granada, Spain, 18014
Contact: Ignacio Puche Sanz, MD   
Principal Investigator: Ignacio Puche Sanz, MD         
Complejo Hospitalario Médico Quirúrjico de Jaén Active, not recruiting
Jaén, Spain, 23007
Hospital de Especialidades de Jerez de La Frontera Active, not recruiting
Jerez de la Frontera, Spain, 11408
Hospital Fundacion Jimenez Diaz Active, not recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain, 28041
Complejo Universitario La Paz Active, not recruiting
Madrid, Spain, 28046
Hospital Universitario Puerta de Hierro Majadahonda Not yet recruiting
Majadahonda, Spain, 28222
Contact: Joaquín Carballido Rodríguez, MD   
Principal Investigator: Joaquín Carballido Rodríguez, MD         
Complejo Hospitalario Regional de Málaga Not yet recruiting
Málaga, Spain, 29010
Contact: Carlos Bautista Vidal, MD   
Principal Investigator: Carlos Bautista Vidal, MD         
Hospital Universitario Central de Asturias Not yet recruiting
Oviedo, Spain, 33011
Contact: Jesús Maria Fernández Gómez, MD   
Principal Investigator: Jesús Maria Fernández Gómez, MD         
Clinica Universidad de Navarra Not yet recruiting
Pamplona, Spain, 31008
Contact: Felipe Villacampa Aubá, MD   
Principal Investigator: Felipe Villacampa Aubá, MD         
Hospital Clínico Universitario de Valladolid Not yet recruiting
Valladolid, Spain, 47003
Contact: Jose Ramón Cortiñas González, MD   
Principal Investigator: Jose Ramón Cortiñas González, MD         
Sponsors and Collaborators
Biofabri, S.L
Fundación para la Investigación en Urología (FIU)
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Principal Investigator: Miguel Unda, MD Hospital Universitario Basurto

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Responsible Party: Biofabri, S.L Identifier: NCT03982797     History of Changes
Other Study ID Numbers: ENCORE-01
2017-002928-24 ( EudraCT Number )
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biofabri, S.L:
non-muscle invasive bladder tumors

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases