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

Inclusion Criteria:

1. Signature of the informed consent before any activity related to the study, includingthe 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. orcarcinoma 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 increasethe risk of the subject or reduce the chances of obtaining satisfactory data toachieve the objectives of the study, including the consumption of alcohol or any otherdrug.

5. Administration of BCG in the last year before signing the informed consent. 6. BCGinstillation contraindication during more than 15 days for any cause such as lowbladder capacity, urinary infection, hematuria, etc.

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

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

8. Participation in another clinical study where they received a research drug in the 6months 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), followingmenarche and until becoming post-menopausal unless permanently sterile. Permanentsterilisation methods include hysterectomy, bilateral salpingectomy and bilateraloophorectomy. A postmenopausal state is defined as no menses for 12 months without analternative medical cause.

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