First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC

Bioniche Life Sciences

Status and phase

Withdrawn

Phase 3

Conditions

Bladder Cancer

Treatments

Biological: Mycobacterial Cell-Wall DNA Complex

Biological: Bacillus Calmette-Guerin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01284205

EN3348-302

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)