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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer
• Intervention / Treatment: Biological: Instillation of IMUNO BCG Moreau RJ

• Study Type: Interventional
• Enrollment (Anticipated): 306
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ingrid Murillo, MSc.; Phone Number: 0034986330400; Email: ingrid.murillo@biofabri.es
• Study Contact Backup: Name: Sara Barja, MSc.; Phone Number: 0034986330400; Email: sara.barja@biofabri.es

Study Locations

• Spain
  • Bilbao, Spain, 48013
    • Active, not recruiting
    • Hospital Universitario Basurto
  • Cadiz, Spain, 11009
    • Active, not recruiting
    • Complejo Hospitalario Puerta Del Mar
  • Coruña, Spain, 15006
    • Not yet recruiting
    • Complexo Hospitalario Universitario A Coruña
    • Contact: Venancio Chantada Abal, MD; Email: vchantada@hotmail.com
    • Principal Investigator: Venancio Chantada Abal, MD
  • Córdoba, Spain, 14004
    • Active, not recruiting
    • Complejo Hospitalario Regional Reina Sofía
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de Las Nieves
    • Contact: Ignacio Puche Sanz, MD; Email: nacho.puchesanz@gmail.com
    • Principal Investigator: Ignacio Puche Sanz, MD
  • Jaén, Spain, 23007
    • Active, not recruiting
    • Complejo Hospitalario Médico Quirúrjico de Jaén
  • Jerez de la Frontera, Spain, 11408
    • Active, not recruiting
    • Hospital de Especialidades de Jerez de La Frontera
  • Madrid, Spain, 28041
    • Active, not recruiting
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28040
    • Active, not recruiting
    • Hospital Fundación Jimenez Díaz
  • Madrid, Spain, 28046
    • Active, not recruiting
    • Complejo Universitario La Paz
  • Majadahonda, Spain, 28222
    • Not yet recruiting
    • Hospital Universitario Puerta de Hierro Majadahonda
    • Contact: Joaquín Carballido Rodríguez, MD; Email: carballidojoaquin@gmail.com
    • Principal Investigator: Joaquín Carballido Rodríguez, MD
  • Málaga, Spain, 29010
    • Not yet recruiting
    • Complejo Hospitalario Regional de Málaga
    • Contact: Carlos Bautista Vidal, MD; Email: yenyebaru@hotmail.com
    • Principal Investigator: Carlos Bautista Vidal, MD
  • Oviedo, Spain, 33011
    • Not yet recruiting
    • Hospital Universitario Central de Asturias
    • Contact: Jesús Maria Fernández Gómez, MD; Email: jmfergomez@gmail.com
    • Principal Investigator: Jesús Maria Fernández Gómez, MD
  • Pamplona, Spain, 31008
    • Not yet recruiting
    • Clinica Universidad de Navarra
    • Contact: Felipe Villacampa Aubá, MD; Email: fvauba@unav.es
    • Principal Investigator: Felipe Villacampa Aubá, MD
  • Valladolid, Spain, 47003
    • Not yet recruiting
    • Hospital Clínico Universitario de Valladolid
    • Contact: Jose Ramón Cortiñas González, MD; Email: jrcorti@gmail.com
    • Principal Investigator: Jose Ramón Cortiñas González, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival.	The secondary objective is to assessment the disease-free survival.	24 months
Assessment of the quality of life	Assessment will be measure with FACT-BL version4th	24 months
Assessment of adverse reactions	Assessment will be measure in number and relation with IMP	24 months
Assessment of the dropout rate due to toxicity	Assessment will be measure in number	24 months

Collaborators and Investigators

• Sponsor: Biofabri, S.L
• Collaborators: Fundación para la Investigación en Urología (FIU)
• Investigators: Principal Investigator: Miguel Unda, MD, Hospital Universitario Basurto

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2019
• Primary Completion (Anticipated): April 3, 2021
• Study Completion (Anticipated): March 3, 2022

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: non-muscle invasive bladder tumors
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: ENCORE-01; 2017-002928-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No