Bladder CancerPhase 3NCT01284205
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
A Phase 3 study testing Mycobacterial Cell-Wall DNA Complex and Bacillus Calmette-Guerin in people with Bladder Cancer, run by Bioniche Life Sciences Inc. at 14 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Mycobacterial Cell-Wall DNA Complex and Bacillus Calmette-Guerin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 14 sitesUnited States
- Study dates
- Jan 2010to Feb 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Daytona Beach, Florida
Study site
Englewood, Colorado
Study site
Garden City, New York
Study site
Laguna Hills, California
Study site
Los Angeles, California
Study site
McAllen, Texas
Study site
Myrtle Beach, South Carolina
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Overland Park, Kansas
Study site
Pittsburgh, Pennsylvania
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
Shreveport, Louisiana
About this study
Official title: 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
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
- Bladder Cancer
- Being tested
- Mycobacterial Cell-Wall DNA Complex, Bacillus Calmette-Guerin
- Keywords
- non-muscle invasive bladder cancer, superficial bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycobacterial Cell-Wall DNA ComplexBiological
8 mg/50 mL (sterile WFI) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
Bacillus Calmette-GuerinBiological
mg/50 mL (sterile saline) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
| Study group | Role | What they receive |
|---|---|---|
| MCC | Experimental | Intravesical Administration of Mycobacterial Cell-Wall DNA Complex Receives: Biological: Mycobacterial Cell-Wall DNA Complex |
| BCG | Active comparator | Intravesical Administration of Bacillus Calmette-Guerin Receives: Biological: Bacillus Calmette-Guerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of disease-free survival (time to recurrence, progression or death) in all patients
Measured: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs
Measured: Baseline through 24 months
Secondary outcomes (8)
Disease-free survival rate at 2 years
Measured: Month 24
Frequency, severity, and nature of drug-related AEs
Measured: Baseline through 24 Months
Duration of progression-free survival (time to progression or death) in all patients
Measured: Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60
Frequency, severity, and nature of drug-related SAEs
Measured: Baseline through 24 months
Number of treatment delays and their reason
Measured: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
Frequency, severity and nature of all AEs
Measured: Baseline through 24 months
Number of treatment discontinuations and their reason
Measured: Baseline through 24 months
Duration of Survival (time to death from any cause) in all patients
Measured: Baseline through month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2010
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: This indication is not being pursued at this point in time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioniche Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284205
- Sponsor's protocol ID
- EN3348-302
- Status last verified
- Aug 2014
- First submitted
- 25 Jan 2011
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01284205
- Acronym / sponsor ID
- EN3348-302
- Conditions
- Bladder Cancer
- Keywords
- non-muscle invasive bladder cancer, superficial bladder cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This indication is not being pursued at this point in time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bioniche Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCC | Experimental | Biological: Mycobacterial Cell-Wall DNA ComplexIntravesical Administration of Mycobacterial Cell-Wall DNA Complex |
| BCG | Active comparator | Biological: Bacillus Calmette-GuerinIntravesical Administration of Bacillus Calmette-Guerin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycobacterial Cell-Wall DNA Complex8 mg/50 mL (sterile WFI) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase. | Biological | MCC |
| Bacillus Calmette-Guerinmg/50 mL (sterile saline) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase. | Biological | BCG |
Primary outcome
Duration of disease-free survival (time to recurrence, progression or death) in all patients
Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs
Time frame: Baseline through 24 months
8 secondary outcomes
Disease-free survival rate at 2 years
Time frame: Month 24
Frequency, severity, and nature of drug-related AEs
Time frame: Baseline through 24 Months
Duration of progression-free survival (time to progression or death) in all patients
Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60
Frequency, severity, and nature of drug-related SAEs
Time frame: Baseline through 24 months
Number of treatment delays and their reason
Time frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
Frequency, severity and nature of all AEs
Time frame: Baseline through 24 months
Number of treatment discontinuations and their reason
Time frame: Baseline through 24 months
Duration of Survival (time to death from any cause) in all patients
Time frame: Baseline through month 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
Related trials for Bladder Cancer
Active, not recruitingPhase 2
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Urinary Bladder Neoplasms
Active, not recruitingPhase 1/2
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Non-Muscle Invasive Bladder Neoplasms
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mycobacterial Cell-Wall DNA Complex and Bacillus Calmette-Guerin in people with Bladder Cancer, run by Bioniche Life Sciences Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of disease-free survival (time to recurrence, progression or death) in all patients (time frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014; AzTrials last refreshed its copy on 4 Nov 2026.