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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03982797
• Other study ID #: ENCORE-01
• Secondary ID: 2017-002928-24
• Status: Recruiting
• Phase: Phase 2
• Start date: May 17, 2019
• Est. completion date: March 3, 2022

Study information

• Verified date: June 2019
• Source: Biofabri, S.L
• Contact: Ingrid Murillo, MSc.
• Phone: 0034986330400
• Email: ingrid.murillo[@]biofabri.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: March 3, 2022
• Est. primary completion date: April 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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 .

Locations

Country	Name	City	State
Spain	Hospital Universitario Basurto	Bilbao
Spain	Complejo Hospitalario Puerta Del Mar	Cadiz
Spain	Complejo Hospitalario Regional Reina Sofía	Córdoba
Spain	Complexo Hospitalario Universitario A Coruña	Coruña
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Complejo Hospitalario Médico Quirúrjico de Jaén	Jaén
Spain	Hospital de Especialidades de Jerez de La Frontera	Jerez de la Frontera
Spain	Complejo Universitario La Paz	Madrid
Spain	Hospital Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda
Spain	Complejo Hospitalario Regional de Málaga	Málaga
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
Biofabri, S.L	Fundación para la Investigación en Urología (FIU)

Country where clinical trial is conducted

Spain, 

Outcome

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