Reduced BCG dwell time in patients who are diagnosed with high risk non-muscle-invasive- bladder cancer MedDRA version: 20.0 Level: LLT Classification code 10005004 Term: Bladder cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: BCG medac
Product Name: BCG medac
Product Code: L03AX03
Pharmaceutical Form: Powder and solvent for intravesical suspension
Pharmaceutical form of the placebo: Powder and solvent for intra
Sponsors
Aarhus University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • =18 years of age at the time of signing the Informed Consent Form • Signed Informed Consent Form • Patients with NMIBC where BCG therapy including maintenance for 1 year is planned for one of the following histopathological findings: • Ta high grade without CIS • CIS with or without previous or concomitant Ta tumors • T1 with or without CIS • Is, according to the Investigator’s judgement, able to comply with the trial protocol • Ability to understand the Patient Information Sheet orally and in writing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 214
Exclusion criteria
Exclusion criteria: • Previous BCG instillation within the last 2 years, because of the risk of not having cleared potential previous side effects • T1 tumors where re-resection had not been performed • TUR-B, bladder biopsy or traumatic catheterization within 2 weeks. • Previous or current MIBC • Progression defined as progression to T1- tumour, T2+-tumour or cystectomy irrespectively of indication or development of metastatic urothelial cancer irrespectively of tumour stage • Contraindications to BCG • Incontinence • Bilateral nephrostomy catheters; Unilateral nephrostomy catheter is allowed if permanent for the duration of all instillations with BCG and a normally functioning kidney • Need for catheter at the time of instillation • Immune Suppressing medication (cancer therapy e.g cytostatic medicinal products, radiation, local and systemic steroids like e.g. prednisolone is permitted) • Reduced immune response (leukaemia, lymphoma) • Known allergy or sensitivity to BCG • HIV infection • Signs of active tuberculosis • Any type of previously radiation therapy involving the bladder • Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without matastasis • Current urinary tract infection • Patient with visible hematuria • Current alcohol and/or drug abuse • Has a mental or legal incapacitation or another condition which impair the subject’s ability to participate • Has participated in another interventional clinical study and treatment with another investigational product 30 days days prior to randomization • For women study subjects: Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial aims to evaluate the potential clinical impact of a new regimen with reduction of dwell-time during once-weekly BCG instillations for 6 weeks followed by maintenance therapy for 12 months in regards to side effects, adherence to instillation regimen and oncological outcome.;Secondary Objective: •Recurrence rate within 24 months in Study Subjects with initial complete response •Progression rate within 24 months and 60 months •Disease specific survival within 24 months and 60 months •Overall survival within 24 months and 60 months •Total no. of BCG instillations per Study Subject •No. of Study Subjects completing all 6 induction instillations •Number of BCG instillations given with full dwell-time of 2 hours per Study Subject •Number of installations per Study Subject postponed 1 week or more because of side effect •Number of Study Subjects where instillations is stopped because of local side effects •Number of Study Subjects where instillations is stopped because of systemic side effects •Complete response rate following induction therapy defined as no recurrence at first cystoscopy after induction therapy •Number of Study Subjects undergoing re-induction therapy within 24 months because of recurrent or persistent disease ;Primary end point(s): Number of Study Subjects completing all 6 induction instillations and subsequent maintenance installations for 12 months (6 + 3 x 3) ;Timepoint(s) of evaluation of this end point: 13 months after investigational treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Recurrence rate within 24 months in Study Subjects with initial complete response • Progression rate within 24 months and 60 months • Disease specific survival within 24 months and 60 months • Overall survival within 24 months and 60 months • Total number of BCG instillations per Study Subject • Number of Study Subjects completing all 6 induction instillations • Number of BCG instillations given with full dwell-time of 2 hours per Study Subject • Number of installations per Study Subject postponed 1 week or more because of side effect • Number of Study Subjects where instillations is stopped because of local side effects • Number of Study Subjects where instillations is stopped because of systemic side effects • Complete response rate following induction therapy defined as no recurrence at first cystoscopy after induction therapy • Number of Study Subjects undergoing re-induction therapy within 24 months because of recurrent or persistent disease ;Timepoint(s) of evaluation of this end point: November 1, 2027 | — |
Countries
Denmark, Iceland, Norway, Sweden
Contacts
Public ContactJørgen Bjerggaard Jensen
Aarhus University
Outcome results
None listed