Last reviewed · How we verify
NCT06767982
Comparison of BCG RIVM and Russian Strains for Treating Non-Muscle-Invasive Bladder Cancer (NMIBC)
Phase 4 trial testing Bacillus Calmette-Guerin (BCG) in Non Muscle Invasive Bladder Cancer in 160 participants. Completed in 31 December 2022.
31 December 2022
Quick facts
| Lead sponsor | Ankara University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 160 |
| Start date | 1 January 2019 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Bacillus Calmette-Guerin (BCG) — full drug profile →
Conditions studied
- Non Muscle Invasive Bladder Cancer — all drugs for Non Muscle Invasive Bladder Cancer →
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):
-
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:
- PubMed search for NCT06767982
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bacillus Calmette-Guerin (BCG)
Trials testing the same drug.
- NCT04507126 — A Pilot Study of the Effects of BCG Immunization on CSF and Blood-based Biomarkers in Older Adults. · Phase 2 · completed
- NCT03528694 — Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasiv · Phase 3 · active not recruiting
Other recruiting trials for Non Muscle Invasive Bladder Cancer
Currently open trials in the same condition.
- NCT07283835 — Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Gue · Phase 2 · recruiting
- NCT07036731 — A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Pati · NA · recruiting
- NCT06181266 — A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer · Phase 1 · active not recruiting
- NCT05981131 — Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC) · active not recruiting
- NCT06287541 — The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative · NA · recruiting
Other Ankara University trials
Trials by the same sponsor.
- NCT07441837 — Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients · Phase 2 · not yet recruiting
- NCT07536490 — Sleep Quality, Cognition, and Disease Severity in Parkinson's Disease · not yet recruiting
- NCT06959433 — Lu-177 PSMA Treatment in Cell Renal Carcinoma · Phase 3 · not yet recruiting
- NCT07513272 — EFFECT OF BALLS ON PAIN AND ANXIETY DURING VENIPUNCTURE IN CHILDREN · NA · not yet recruiting
- NCT07536542 — Effects of Dual-Task Training on Upper Extremity Function in Parkinson's Disease · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06767982 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ankara University
- Last refreshed: 10 January 2025
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing