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

Biofabri

Status and phase: Unknown; Phase 2

Conditions: Bladder Cancer

Treatments: Biological: Instillation of IMUNO BCG Moreau RJ

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03982797

ENCORE-01

2017-002928-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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306 participants in 1 patient group

treated with IMUNO BCG Moreau RJ adjuvant.

Experimental group

Treatment:

Biological: Instillation of IMUNO BCG Moreau RJ