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

Withdrawn before enrolling · Phase 3

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT01284205

Run by

Bioniche Life Sciences Inc.

People needed

0

Starts

2010-01-01

Expected to finish

2017-02-01

Last updated by the study team

2014-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Laguna Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Overland Park, Kansas, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Garden City, New York, United States
• Study site — New York, New York, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Myrtle Beach, South Carolina, United States
• Study site — McAllen, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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