MYCOBACTERIUM BOVIS BACILLUS CALMETTE-GUÉRIN, STRAIN MOEAU RIO DE JANEIRO, LIVE for Non-muscle invasive bladder cancer (high-risk)

Inclusion criteria

• {"criterion_text":"- Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection\n- Age between 18 and 85 years at the time of signing the informed consent.\n- Urothelial tumor\n- 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.\n- Patient with risk of recurrence or progression greater than or equal to 7 points, according to CUETO tables"}

Exclusion criteria

• {"criterion_text":"- No muscle layer in pathological examination piece's\n- 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.\n- Patients with difficulties to perform the follow-up visits established in the protocol.\n- Non-urothelial tumor\n- Active cancer in any other location\n- 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.\n- Administration of BCG in the last year before signing the informed consent.\n- BCG first instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc\n- Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.\n- Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU)\n- Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent"}

Primary endpoints

• {"endpoint_text":"- The effectiveness of the IMUNO BCG Moreau RJ strain will be assessed primarily by calculating the rate of progression at 24 months after the last transurethral resection (LTRU). The progression rate at 24 months is the proportion of patients who, after the last tumor resection and within a follow-up period of 24 months, undergo progression according to the TNM classification approved by the International Union Against Cancer in its 8th edition of 2017.","definition_or_measurement_approach":"Progression rate at 24 months: proportion of patients who, after the last tumour resection and within 24 months follow-up, have progression defined by the TNM classification (UICC 8th edition, 2017)."}

Secondary endpoints

• {"endpoint_text":"- Progression rate at 12 months: proportion of patients, out of the total, who have been on treatment with the IMUNO BCG Moreau RJ strain and in whom the tumour has progressed within a 12-month follow-up period.","definition_or_measurement_approach":"Progression rate at 12 months measured as the proportion of treated patients with tumour progression within 12 months."}
• {"endpoint_text":"- Progression rate at 24 months: proportion of patients, out of the total, who have been on treatment with the IMUNO BCG Moreau RJ strain and in whom the tumour has progressed within a follow-up period of 24 months.","definition_or_measurement_approach":"Progression rate at 24 months measured as the proportion of treated patients with tumour progression within 24 months."}
• {"endpoint_text":"- Disease-free survival: tumour classification (TNM) from the date of first instillation (time zero) to recurrence or end of follow-up will be assessed.","definition_or_measurement_approach":"Disease-free survival assessed from date of first instillation to recurrence or end of follow-up using TNM tumour classification."}
• {"endpoint_text":"- Quality of life: questionnaire published and validated in the scientific literature and adapted to Spanish, Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-BL) v. 4.","definition_or_measurement_approach":"Quality of life measured using FACT-BL v4 questionnaire (validated and adapted to Spanish)."}
• {"endpoint_text":"- Adverse reactions (ARs): the description of ARs will be based on the MedDRA dictionary of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The number and frequency of patients with AEs, their severity, as well as the distribution of all AEs will be described.","definition_or_measurement_approach":"Adverse reactions coded by MedDRA; report number and frequency of patients with AEs, severity, and distribution."}
• {"endpoint_text":"- Dropout rate due to toxicity: study withdrawals (number and percentage) due to the impossibility of continuing due to side effects will be evaluated, as well as those patients who have not discontinued.","definition_or_measurement_approach":"Number and percentage of study withdrawals due to toxicity will be calculated."}
• {"endpoint_text":"- Immunological response: analysis of cytokines in urine prior to instillation at induction visits 1, 2, 5 and 6.","definition_or_measurement_approach":"Immunological response assessed by analysis of cytokines in urine collected prior to instillation at induction visits 1,2,5 and 6."}

Spain

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

28-11-2025

Processing Time Days

396

Number Of Sites

15

Number Of Participants

306

Primary sponsor

Full Name

Biofabri S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Kapadi Spain S.L.","duties_or_roles":"Codes: 1,10,11,12,2,6,7,8","organisation_type":"Pharmaceutical company"}

Co-sponsors

• Fundacion Para La Investigacion En Urologia