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NCT06767982

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

Completed Phase 4 Last updated 10 January 2025
What this trial tests

Phase 4 trial testing Bacillus Calmette-Guerin (BCG) in Non Muscle Invasive Bladder Cancer in 160 participants. Completed in 31 December 2022.

Timeline
1 January 2019
Primary endpoint
31 December 2022
31 December 2022

Quick facts

Lead sponsorAnkara University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment160
Start date1 January 2019
Primary completion31 December 2022
Estimated completion31 December 2022
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Ankara University

Who can join

Eligibility, any sex, with Non Muscle Invasive Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Engineered bacteria for cancer therapy: Advancements, challenges, and future directions.
    Wang M, Liu M, Wang D, Yang D, et al · · 2025 · PMID 41243447 · DOI 10.1097/cm9.0000000000003807

Verify or expand the search:

Other trials of Bacillus Calmette-Guerin (BCG)

Trials testing the same drug.

Other recruiting trials for Non Muscle Invasive Bladder Cancer

Currently open trials in the same condition.

Other Ankara University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06767982.

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