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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biofabri S.L., Fundacion Para La Investigacion En Urologia

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Apr 2019 → ongoing

Decision date (initial)

2024-12-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-519288-17-00

EudraCT number

2017-002928-24

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis, Efficacy, Safety

Assessment of progression-free survival in patients diagnosed with high-risk non-muscle infiltrating bladder tumours (NMIBT) treated with adjuvant IMUNO BCG Moreau RJ.

Secondary objectives 6

1. Disease progression rates at 12 and 24 months
2. Assessment of disease-free survival
3. Quality of life assessment
4. Assessment of adverse reactions
5. Assessment of the rate of drop-out due to toxicity
6. Assessment of the immune response -Assessment of the immune response

Conditions and MedDRA coding

High-risk Non-muscle Invasive Bladder Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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 85 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 7 points, according to CUETO tables

Exclusion criteria 11

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 first 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 7

1. 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.
2. 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.
3. Disease-free survival: tumour classification (TNM) from the date of first instillation (time zero) to recurrence or end of follow-up will be assessed.
4. 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.
5. 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.
6. 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.
7. Immunological response: analysis of cytokines in urine prior to instillation at induction visits 1, 2, 5 and 6.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biofabri S.L.

Sponsor organisation

Biofabri S.L.

Address

Calle Relva S/n

City

O Porrino

Postcode

36410

Country

Spain

Scientific contact point

Organisation

Biofabri S.L.

Contact name

Ingrid Murillo Jelsbak

Public contact point

Organisation

Biofabri S.L.

Contact name

Ingrid Murillo Jelsbak

Third parties 1

Fundacion Para La Investigacion En Urologia

Sponsor organisation

Fundacion Para La Investigacion En Urologia

Address

Calle De Valenzuela 6 1 Derecha

City

Madrid

Postcode

28014

Country

Spain

Sponsor responsibilities

Article 77 compliance

Biofabri S.L.

Contact point sponsor

Biofabri S.L.

Article 77 implementation

Biofabri S.L.

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications