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Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer (EMBARC-RF)

Primary Purpose

Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EN3348
Mitomycin C
Sponsored by
Bioniche Life Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Neoplasm focused on measuring Urinary Bladder Neoplasms, Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Urinary Bladder Diseases, Urologic Diseases, Mycobacterial cell wall DNA complex, Intravesical drug administration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is 18 years of age and older at time of consent signing
  • Have either BCG recurrent or refractory NMIBC:

    • Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1 and/or CIS) at least 6 months from the start of a full induction course of BCG with or without maintenance/re-treatment at 3 months
    • Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months following a full induction course of BCG with or without maintenance/re-treatment at 3 months. Subjects with recurrent disease must have recurred within 18 months following the last dose of BCG

      • A full induction course of BCG is defined as at least 5 out of 6 total expected instillations of BCG within a period of 2 months, regardless of dose strength
  • Have histologically confirmed NMIBC (according to 2004 WHO classification) within 8 weeks prior to randomization

    • High grade Ta papillary lesion(s)
    • High or low grade T1 papillary lesion(s)(biopsy sample must include evidence of muscularis propria)
    • CIS, with or without Ta or T1 papillary tumor(s) of any grade
  • Have had all visible papillary and resectable CIS lesion(s) removed by TURBT within 8 weeks prior to randomization
  • Available for the duration of the study including follow-up (approximately 36 months)
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 2 or less
  • Have no evidence of urothelial carcinoma involving the upper urinary tract or the urethra (confirmed by extravesical work up, which may include radiological imaging and/or biopsy) within 6 months of randomization:

    • If previous work up occurred more than 6 months from randomization, extravesical work up must be repeated prior to randomization in order to determine eligibility
  • Subjects (male and female) of child-bearing potential (including female subjects who are post-menopausal for less than 1 year) must be willing to practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment
  • Is able to understand and give written informed consent

Exclusion Criteria:

  • Current or previous history of muscle invasive bladder tumors
  • Current or previous history of lymph node positive and/or metastatic bladder cancer
  • Current evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder
  • Currently receiving systemic cancer therapy (cytotoxic/cytostatic or immunotherapy)
  • Currently receiving treatment with a prohibited therapy
  • Current or prior history of systemic lupus erythematosus
  • Systemic immunotherapy within 6 months of randomization
  • Treatment with an investigational agent within 30 days or 5 half lives from randomization, whichever is longer
  • Prior treatment with an intravesical chemotherapeutic agent within 3 months of randomization except for single perioperative dose of chemotherapy immediately post-TURBT
  • Prior treatment with EN3348 (MCC) or any other mycobacterial cell wall composition or formulation
  • Refractory to mitomycin C (failure to achieve tumor-free status following minimum of a 6 week induction course of mitomycin C)
  • Contraindication to mitomycin C
  • Untreated urinary tract or bladder infection
  • ANC <1000/µL and hemoglobin <10 g/dL
  • Known cardiovascular disease such as myocardial infarction within the past 3 months, unstable angina pectoris, congestive heart failure (NYHA Class III or IV) or uncontrolled cardiac arrhythmia
  • Female subjects who are pregnant or lactating
  • Congenital or acquired immune deficiency
  • Have current or history of documented or suspected malignancy of any organ system (diagnosed, treated or untreated) within the past 5 years (with the exception of localized transitional cell carcinoma of the ureter treated with ureterectomy or nephroureterectomy, adequately treated basal cell or squamous cell carcinoma of the skin or asymptomatic non-metastatic prostate cancer either previously successfully treated or currently under active surveillance or receiving hormone therapy only)
  • Bladder contracture or history of an inability to retain the instillate for a minimum of 1 hour, even with premedication
  • Inability to tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)
  • Clinically significant active infections
  • Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol

Sites / Locations

  • Alaska Clinical Research Center, LLC
  • BCG Oncology, PC
  • Arizona Urologic Specialists
  • Urology Specialists of Southern California - Burbank
  • Urology Specialist of Southern California - Encino
  • American Institute of Research
  • San Diego Clinical Trials
  • West Coast Clinical Research
  • Urology Specialists of Southern California - Torrance
  • The Urology Center of Colorado
  • Genitourinary Surgical Consultants, PC
  • Urology Associates
  • University of Connecticut Health Center
  • Grove Hill Medical Center
  • Florida Urological Associates, PA
  • Urological Research Network
  • Urology Health Team, PLLC
  • Advanced Research Institute, Inc.
  • Northwestern Medicine
  • University of Chicago
  • Deaconess Clinic, Inc.
  • Northeast Indiana Research, LLC
  • Kansas City Urology Care, P.A.
  • University of Maryland
  • Chesapeake Urology Research Associates
  • Corbin Clinical Resources
  • Chesapeake Urology Research Associates
  • Myron I. Murdock, MD, LLC
  • Chesapeake Urology Research Associates
  • Bay State Urologists
  • Michigan Institute of Urology
  • Delaware Valley Urology, LLC Burlington
  • Delaware Valley Urology
  • The Capital Region Medical Research Foundation, Inc.
  • Accumed Research Associates
  • Columbia University Medical Center
  • Premier Medical Group of the Hudson Valley
  • Montefiore Medical Center
  • TriState Urologic Services PSC, Inc.
  • Columbus Urology
  • Signal Point Clinical Research Center, LLC
  • Unison Clinical Research
  • Parkhurst Research Organization, LLC
  • Urologic Consultants of SE PA
  • Urology Health Specialists, LLC
  • Ilumina Clinical Associates
  • Triangle Urological Group
  • University of Pittsburgh
  • Mount Nittany Physician Group
  • Pharma Resource
  • Carolina Urologic Research Center
  • Vanderbilt University Medical Center
  • Urology Associates of North Texas
  • Urology Clinics of North Texas, PA
  • Urology Associates of South Texas
  • Virginia Urology
  • Southern Interior Medical Research, Inc.
  • Pacific Urologic Research
  • London Health Sciences Centre
  • Mor Urology Inc.
  • Office of Dr. Bernard Goldfarb
  • The Fe/Male Health Centres
  • Sunnybrook Health Sciences Centre
  • Princess Margaret Hospital - University Health Network
  • Centre Hospitalier Universitaire de Quebec- L'Hotel-Dieu de Quebec
  • GUT (Society of Urologic Innovative Therapies), GbR
  • Universitair Medisch Centrum St Radboud, Department of Urology
  • Uniwersyteckie Centrum Kliniczne
  • Oddział Urologii, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie [Department of Urology, Independent Public Teaching Hospital #4 in Lublin]
  • Maria Sklodowska-Curie Institute of Oncology
  • Wojewódzki Szpital Specjalistyczny we Wrocławiu
  • Nottingham Urology Centre, NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EN3348

Mitomycin C

Arm Description

8 mg mixed with sterile water for injection for a total volume of 50mL

40 mg powder will be reconstituted with sterile water for injection to a total volume of 40 mL

Outcomes

Primary Outcome Measures

Comparison of Event-free Survival of Intravesical EN3348 With Mitomycin C.
Primary efficacy endpoint will be event-free survival - the interval from randomization to an event. An event is defined as tumor recurrence, tumor progression to muscle invasive bladder cancer or death, whichever occurs first. Tumor recurrence or progression must be documented by bladder biopsy.

Secondary Outcome Measures

Comparison of Safety of EN3348 With Mitomycin C [Adverse Events (Other Than Serious Adverse Events) With Frequency Threshold of 5% or Greater].
Safety endpoint displayed includes adverse events (other than serious adverse events) with a frequency threshold of 5% or greater, for each treatment arm. No statistical comparisons have been performed between the 2 treatment arms.

Full Information

First Posted
September 12, 2010
Last Updated
August 23, 2017
Sponsor
Bioniche Life Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01200992
Brief Title
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
Acronym
EMBARC-RF
Official Title
A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of Recruitment
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioniche Life Sciences Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide. Subjects with either recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for participation in this study. Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1, and/or CIS) at least 6 months from the start of a full induction course of BCG with or without maintenance/re-treatment at 3 months. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months following a full induction course of BCG with or without maintenance/re-treatment at 3 months. Subjects with recurrent disease must have recurred within 18 months following the last dose of BCG. Approximately 450 subjects will be randomized. The primary objective of this study is to evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment of subjects with recurrent or refractory NMIBC. The secondary objective is to evaluate the safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC. This study will consist of 4 phases: Screening, Induction, Maintenance and Follow-Up and will be conducted over 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ, Mycobacterium
Keywords
Urinary Bladder Neoplasms, Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Urinary Bladder Diseases, Urologic Diseases, Mycobacterial cell wall DNA complex, Intravesical drug administration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EN3348
Arm Type
Experimental
Arm Description
8 mg mixed with sterile water for injection for a total volume of 50mL
Arm Title
Mitomycin C
Arm Type
Active Comparator
Arm Description
40 mg powder will be reconstituted with sterile water for injection to a total volume of 40 mL
Intervention Type
Biological
Intervention Name(s)
EN3348
Intervention Description
Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12
Intervention Type
Biological
Intervention Name(s)
Mitomycin C
Intervention Description
Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12
Primary Outcome Measure Information:
Title
Comparison of Event-free Survival of Intravesical EN3348 With Mitomycin C.
Description
Primary efficacy endpoint will be event-free survival - the interval from randomization to an event. An event is defined as tumor recurrence, tumor progression to muscle invasive bladder cancer or death, whichever occurs first. Tumor recurrence or progression must be documented by bladder biopsy.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Comparison of Safety of EN3348 With Mitomycin C [Adverse Events (Other Than Serious Adverse Events) With Frequency Threshold of 5% or Greater].
Description
Safety endpoint displayed includes adverse events (other than serious adverse events) with a frequency threshold of 5% or greater, for each treatment arm. No statistical comparisons have been performed between the 2 treatment arms.
Time Frame
Through study early termination, approximately 23 months from first subject enrolled.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is 18 years of age and older at time of consent signing Have either BCG recurrent or refractory NMIBC: Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1 and/or CIS) at least 6 months from the start of a full induction course of BCG with or without maintenance/re-treatment at 3 months Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months following a full induction course of BCG with or without maintenance/re-treatment at 3 months. Subjects with recurrent disease must have recurred within 18 months following the last dose of BCG A full induction course of BCG is defined as at least 5 out of 6 total expected instillations of BCG within a period of 2 months, regardless of dose strength Have histologically confirmed NMIBC (according to 2004 WHO classification) within 8 weeks prior to randomization High grade Ta papillary lesion(s) High or low grade T1 papillary lesion(s)(biopsy sample must include evidence of muscularis propria) CIS, with or without Ta or T1 papillary tumor(s) of any grade Have had all visible papillary and resectable CIS lesion(s) removed by TURBT within 8 weeks prior to randomization Available for the duration of the study including follow-up (approximately 36 months) Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 2 or less Have no evidence of urothelial carcinoma involving the upper urinary tract or the urethra (confirmed by extravesical work up, which may include radiological imaging and/or biopsy) within 6 months of randomization: If previous work up occurred more than 6 months from randomization, extravesical work up must be repeated prior to randomization in order to determine eligibility Subjects (male and female) of child-bearing potential (including female subjects who are post-menopausal for less than 1 year) must be willing to practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment Is able to understand and give written informed consent Exclusion Criteria: Current or previous history of muscle invasive bladder tumors Current or previous history of lymph node positive and/or metastatic bladder cancer Current evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder Currently receiving systemic cancer therapy (cytotoxic/cytostatic or immunotherapy) Currently receiving treatment with a prohibited therapy Current or prior history of systemic lupus erythematosus Systemic immunotherapy within 6 months of randomization Treatment with an investigational agent within 30 days or 5 half lives from randomization, whichever is longer Prior treatment with an intravesical chemotherapeutic agent within 3 months of randomization except for single perioperative dose of chemotherapy immediately post-TURBT Prior treatment with EN3348 (MCC) or any other mycobacterial cell wall composition or formulation Refractory to mitomycin C (failure to achieve tumor-free status following minimum of a 6 week induction course of mitomycin C) Contraindication to mitomycin C Untreated urinary tract or bladder infection ANC <1000/µL and hemoglobin <10 g/dL Known cardiovascular disease such as myocardial infarction within the past 3 months, unstable angina pectoris, congestive heart failure (NYHA Class III or IV) or uncontrolled cardiac arrhythmia Female subjects who are pregnant or lactating Congenital or acquired immune deficiency Have current or history of documented or suspected malignancy of any organ system (diagnosed, treated or untreated) within the past 5 years (with the exception of localized transitional cell carcinoma of the ureter treated with ureterectomy or nephroureterectomy, adequately treated basal cell or squamous cell carcinoma of the skin or asymptomatic non-metastatic prostate cancer either previously successfully treated or currently under active surveillance or receiving hormone therapy only) Bladder contracture or history of an inability to retain the instillate for a minimum of 1 hour, even with premedication Inability to tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy) Clinically significant active infections Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol
Facility Information:
Facility Name
Alaska Clinical Research Center, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
BCG Oncology, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arizona Urologic Specialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Urology Specialists of Southern California - Burbank
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Urology Specialist of Southern California - Encino
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
West Coast Clinical Research
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Urology Specialists of Southern California - Torrance
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Genitourinary Surgical Consultants, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Urology Associates
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Grove Hill Medical Center
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Florida Urological Associates, PA
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
Urological Research Network
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Urology Health Team, PLLC
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Northeast Indiana Research, LLC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Kansas City Urology Care, P.A.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Corbin Clinical Resources
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Myron I. Murdock, MD, LLC
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Bay State Urologists
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Delaware Valley Urology, LLC Burlington
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Delaware Valley Urology
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
The Capital Region Medical Research Foundation, Inc.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Accumed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Montefiore Medical Center
City
The Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
TriState Urologic Services PSC, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Columbus Urology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43220
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Unison Clinical Research
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Parkhurst Research Organization, LLC
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
Urologic Consultants of SE PA
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Urology Health Specialists, LLC
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Ilumina Clinical Associates
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Facility Name
Triangle Urological Group
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Mount Nittany Physician Group
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Pharma Resource
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Urology Associates of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
Facility Name
Urology Clinics of North Texas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Urology Associates of South Texas
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Southern Interior Medical Research, Inc.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Pacific Urologic Research
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N1
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Mor Urology Inc.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3X 1W1
Country
Canada
Facility Name
Office of Dr. Bernard Goldfarb
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 7K8
Country
Canada
Facility Name
The Fe/Male Health Centres
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec- L'Hotel-Dieu de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada
Facility Name
GUT (Society of Urologic Innovative Therapies), GbR
City
Kirchheim unter Teck
ZIP/Postal Code
73230
Country
Germany
Facility Name
Universitair Medisch Centrum St Radboud, Department of Urology
City
Nijmegen
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Oddział Urologii, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie [Department of Urology, Independent Public Teaching Hospital #4 in Lublin]
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Maria Sklodowska-Curie Institute of Oncology
City
Warszawa
ZIP/Postal Code
20-781
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny we Wrocławiu
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Nottingham Urology Centre, NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

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Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer

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