ordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC Short title: NORTH-REG Dwell-Time Study

Phase 1

• Conditions: Reduced BCG dwell time in patients who are diagnosed with high risk non-muscle-invasive- bladder cancer; MedDRA version: 20.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003112-27-SE
• Lead Sponsor: Aarhus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 314

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

•Previous BCG instillations
•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
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified