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

Phase 2

• Conditions: Bladder Cancer
• Interventions: Biological: Instillation of IMUNO BCG Moreau RJ

• Registration Number: NCT03982797
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-17
• Status Verified: 2019-06
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-10
• Last Update Submitted: 2019-06-10
• Study First Posted: 2019-06-12
• Last Update Posted: 2019-06-12
• Primary Completion: 2021-04-03
• Study Completion: 2022-03-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 306

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.

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

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

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

9. 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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treated with IMUNO BCG Moreau RJ adjuvant.	Instillation of IMUNO BCG Moreau RJ	-

Primary Outcome Measures

Name	Time	Method
progression-free survival	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

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

Trial Locations

Locations (15)

Hospital Universitario Basurto; 🇪🇸 Bilbao, Spain

Complejo Hospitalario Puerta Del Mar; 🇪🇸 Cadiz, Spain

Complexo Hospitalario Universitario A Coruña; 🇪🇸 Coruña, Spain

Complejo Hospitalario Regional Reina Sofía; 🇪🇸 Córdoba, 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

Hospital Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Complejo Universitario La Paz; 🇪🇸 Madrid, Spain

Complejo Hospitalario Regional de Málaga; 🇪🇸 Málaga, Spain

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Majadahonda, Spain

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain