Clinical trial · Interventional
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
Randomized, Double-blind, Multi-center Study Comparing MCC to BCG as First Line Immunotherapy in Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Recurrence or Progression
NCT01284205CI-TRIAL-00015505withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This indication is not being pursued at this point in time.
Summary
Brief summary (as posted)
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacillus Calmette-Guerin | Biological | — | UNRESOLVED |
| Mycobacterial Cell-Wall DNA Complex | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MCC
- description
- Intravesical Administration of Mycobacterial Cell-Wall DNA Complex
- interventionNames
- Biological: Mycobacterial Cell-Wall DNA Complex
- type
- ACTIVE_COMPARATOR
- label
- BCG
- description
- Intravesical Administration of Bacillus Calmette-Guerin
- interventionNames
- Biological: Bacillus Calmette-Guerin
Primary outcomes (2)
- measure
- Duration of disease-free survival (time to recurrence, progression or death) in all patients
- timeFrame
- Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS) * histologically confirmed diagnosis within 42 days of study treatment * life expectancy of greater than 5 years * ECOG performance status of 2 or less * absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment Exclusion Criteria: * current or previous history of muscle invasive bladder tumors (\>T2) * current or previous history of lymph node and/or distant metastases from bladder cancer * current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder * current systemic cancer therapy * previous immunotherapy for bladder cancer * previous intravesical chemotherapy treatment * contraindication to use BCG of known tolerance to BCG * history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage T1 prostate cancer, carcinoma in situ of the cervix, colon polyps) * patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)
References
Publications (0)
Data not yet available
No reference posted for this study.