Comparison of BCG RIVM and Russian Strains for Treating Non-Muscle-Invasive Bladder Cancer (NMIBC)

NCT06767982 | Completed Phase 4

• 1 other identifier: İ10-640-21
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the efficacy and safety of two Bacillus Calmette-Guérin (BCG) substrains (RIVM and Russian) in the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) in adult patients. The main questions it aims to answer are:

• Is there a significant difference in recurrence-free survival (RFS) between the BCG RIVM and BCG Russian substrains?
• Is there a significant difference in progression-free survival (PFS) between the two substrains?
• Are there notable differences in the incidence of treatment-related adverse events between the strains? Researchers will compare patients treated with BCG RIVM to patients treated with BCG Russian to determine whether one substrain offers superior clinical outcomes in terms of recurrence, progression, and adverse events. Participants will: Undergo transurethral resection of bladder tumor (TURBT) prior to initiating therapy. Be randomly assigned to receive either BCG RIVM or BCG Russian intravesical therapy. Receive an induction course of six weekly instillations of the assigned BCG substrain. Receive maintenance therapy at regular intervals (3, 6, 12, 18, 24, 30, and 36 months) based on risk classification. Undergo regular follow-up with cystoscopy and urine cytology to assess recurrence, progression, and adverse events.

Conditions

Non Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• recurrence free survival

  Through study completion, up to 4 years

• progression free survival

  Through study completion, up to 4 years

Secondary Outcomes (1)

• side effects of the treatment

  At each BCG instillation and follow-up visit, up to 4 years

Study Arms (2)

Group 1 which received BCG RIVM

ACTIVE COMPARATOR

following transurethral resection of bladder tumor (TURBT), patients in Group 1 received BCG RIVM.

Drug: Bacillus Calmette-Guerin (BCG)

Group 2 which received BCG RUSSIAN

ACTIVE COMPARATOR

following transurethral resection of bladder tumor (TURBT), patients in Group 2 received BCG RUSSIAN.

Drug: Bacillus Calmette-Guerin (BCG)

Interventions

Bacillus Calmette-Guerin (BCG) DRUG

In this study we compared the efficacy and side effects of two different strains of BCG (RIVM and RUSSIAN strains) in non muscle invasive bladder cancer patients

Group 1 which received BCG RIVM; Group 2 which received BCG RUSSIAN

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years,
• histopathologically confirmed NMIBC (stages Ta, T1, or CIS),
• classification as intermediate, high, or very high risk (who either refused or were not suitable candidates for radical cystectomy),
• no prior BCG therapy,
• no evidence of upper urinary tract carcinoma or distant metastases and
• a minimum follow-up period of 12 months.

You may not qualify if:

• patients who did not receive adequate BCG therapy (defined as receiving fewer than 5 of the 6 induction doses or fewer than 2 of the 3 maintenance doses),
• patients with a follow-up period of less than 12 months and
• patients who received multiple BCG strains during the follow-up period.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine Ibni Sina Hospital

Ankara, Altindag, Turkey (Türkiye)

Location

Related Publications (5)

• Unda-Urzaiz M, Cozar-Olmos JM, Minana-Lopez B, Camarero-Jimenez J, Brugarolas-Rossello X, Zubiaur-Libano C, Ribal-Caparros MJ, Suarez-Charneco AJ, Rodriguez-Tesedo V, Chantada-Abal V, Ruiz-de-Leon C, Carrillo-George C, Carballido-Rodriguez J, Villacampa-Auba F; en representacion del Grupo Espanol del Registro de Cepas de BCG. Safety and efficacy of various strains of bacille Calmette-Guerin in the treatment of bladder tumours in standard clinical practice. Actas Urol Esp (Engl Ed). 2018 May;42(4):238-248. doi: 10.1016/j.acuro.2017.10.003. Epub 2017 Dec 30. English, Spanish.

  PMID: 29295749 BACKGROUND

• Niwa N, Kikuchi E, Matsumoto K, Kosaka T, Mizuno R, Oya M. Does switching the bacillus Calmette-Guerin strain affect clinical outcome in patients with recurrent non-muscle-invasive bladder cancer after initial bacillus Calmette-Guerin therapy? Urol Oncol. 2018 Jun;36(6):306.e1-306.e8. doi: 10.1016/j.urolonc.2018.02.005. Epub 2018 Mar 9.

  PMID: 29530465 BACKGROUND

• Krajewski W, Matuszewski M, Poletajew S, Grzegrzolka J, Zdrojowy R, Kolodziej A. Are There Differences in Toxicity and Efficacy between Various Bacillus Calmette-Guerin Strains in Bladder Cancer Patients? Analysis of 844 Patients. Urol Int. 2018;101(3):277-284. doi: 10.1159/000492722. Epub 2018 Sep 18.

  PMID: 30227437 BACKGROUND

• Del Giudice F, Busetto GM, Gross MS, Maggi M, Sciarra A, Salciccia S, Ferro M, Sperduti I, Flammia S, Canale V, Chung BI, Conti SL, Eisenberg ML, Skinner EC, De Berardinis E. Efficacy of three BCG strains (Connaught, TICE and RIVM) with or without secondary resection (re-TUR) for intermediate/high-risk non-muscle-invasive bladder cancers: results from a retrospective single-institution cohort analysis. J Cancer Res Clin Oncol. 2021 Oct;147(10):3073-3080. doi: 10.1007/s00432-021-03571-0. Epub 2021 Mar 6.

  PMID: 33675400 BACKGROUND

• Huang Z, Liu H, Wang Y, Zhang C, Xu T. Determining optimal maintenance schedules for adjuvant intravesical bacillus Calmette-Guerin immunotherapy in non-muscle-invasive bladder cancer: a systematic review and network meta-analysis. Curr Med Res Opin. 2017 Aug;33(8):1379-1387. doi: 10.1080/03007995.2017.1326889. Epub 2017 Jun 6.

  PMID: 28471272 BACKGROUND

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator , Urologist

Model Details: This randomized, prospective trial included 125 patients with intermediate-, high-, and very high-risk non muscle invasive bladder cancer. Patients were randomized into two groups to receive either the BCG RIVM or BCG Russian substrain following transurethral resection of bladder tumor (TURBT).

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 10, 2025
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)