Intravesical instillation therapy with bacillus Calmette-Guérin (BCG) and sequential BCG and electromotive mitomycin-C (EMDA-MMC) in patients with high-risk non-muscle-invasive bladder carcinoma (FINNBLADDER 10)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Turku University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

7 Jan 2019 → ongoing

Decision date (initial)

2024-09-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516320-33-00

EudraCT number

2018-000150-22

ClinicalTrials.gov

NCT03664869

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

The objective of the study is to evaluate the efficacy of intravesical BCG monotherapy and sequential BCG/EMDA-MMC in the treatment of patients with high-risk BC.

Secondary objectives 2

1. To evaluate if sequential BCG/EMDA-MMC is superior to BCG monotherapy in preventing progression, disease specific and overall mortality
2. To evaluate side-effect profiles, tolerability and adverse effects of the different treatment options

Conditions and MedDRA coding

Bladder cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
2. Written informed consent is required from every eligible patient
3. Second resection performed in case of T1 tumour
4. Adequate physical and mental condition to participate in the study (as judged by treating physician

Exclusion criteria 15

1. Ta low grade tumour(s)
2. Muscle invasive (pT≥2) tumors
3. Urothelial cancer involving the prostatic urethra or upper urinary tract
4. Non‐urothelial bladder cancer
5. Prior BCG failure (If patient has previously been successfully treated with BCG, and duration from the last instillation is >12 months, participation may be considered, if bladder preserving is chosen)
6. Prior or concurrent immunotherapy
7. Any medication or condition considered as contraindication to BCG or MMC (as judged by the treating physician)
8. Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by the treating physician)
9. Known allergy to MMC or BCG
10. Age < 18 years
11. Pregnancy or lactating patient
12. Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)
13. Cardiac pacemaker
14. Expected survival time less than one year
15. Expected poor compliance

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Recurrence: defined as occurrence of histologically confirmed urothelial cancer recurrence of any stage or grade. Time for recurrence will be calculated from randomization date to date of biopsy/TUR-BT confirming recurrence.

Secondary endpoints 1

1. Progression: defined as occurrence of biopsy/TUR-BT confirmed urothelial cancer with higher T-category as follows: Time for progression is calculated from randomization to the date of biopsy/TUR-BT/radiological evidence of metastasis confirming progression

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Turku University Hospital

Sponsor organisation

Turku University Hospital

Address

Kiinamyllynkatu 4-8

City

Turku

Postcode

20520

Country

Finland

Scientific contact point

Organisation

Turku University Hospital

Contact name

Urology

Public contact point

Organisation

Turku University Hospital

Contact name

Urology

Locations

1 EU/EEA country · 1 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 10 files

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

Application history

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