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A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (ENVISION)

Primary Purpose

Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
UGN-102
Sponsored by
UroGen Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Non-muscle invasive bladder cancer, Low grade non-muscle invasive bladder cancer, Intermediate risk non-muscle invasive bladder cancer, NMIBC, UGN-102, Mitomycin

Eligibility Criteria

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

Inclusion Criteria:

  1. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
  2. Patient who has LG NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
  3. History of LG NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened.

  4. Has intermediate risk disease, defined as having 1 or 2 of the following:

    • Presence of multiple tumors;
    • Solitary tumor > 3 cm;
    • Early or frequent recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial Screening Visit).
  5. Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening.

  6. Has adequate organ and bone marrow function as determined by routine laboratory tests as below:

    • Leukocytes ≥ 3,000 per μL;
    • Absolute neutrophil count ≥ 1,500 per μL;
    • Platelets ≥ 100,000 per μL;
    • Hemoglobin ≥ 9.0 g/dL;
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
    • Alkaline phosphatase (ALP) ≤ 2.5 × ULN;
    • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
  7. Has an anticipated life expectancy of at least the duration of the trial.
  8. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.

Exclusion Criteria:

  1. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
  2. History of HG bladder cancer (papillary or carcinoma in situ [CIS]) in the past 2 years.
  3. Known allergy or sensitivity to mitomycin that in the Investigator's opinion cannot be readily managed.
  4. Clinically significant urethral stricture that would preclude passage of a urethral catheter.

  5. History of:

    • Neurogenic bladder;
    • Active urinary retention;
    • Any other condition that would prohibit normal voiding.
  6. Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC.
  7. Current tumor grading of T1.
  8. Concurrent upper tract urothelial carcinoma (UTUC).
  9. Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment.
  10. Is pregnant or breastfeeding.
  11. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the Investigator, the patient would be unable to comply with the protocol.
  12. History of prior treatment with an intravesical chemotherapeutic agent in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT.
  13. Has participated in a study with an investigational agent or device within 30 days of enrollment.
  14. Has previously participated in a study in which they received UGN-102.
  15. Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous basal cell or squamous cell carcinomas that can be treated locally are allowed.
  16. Has any other clinically significant medical or surgical condition that in the Investigator's opinion could compromise patient safety or the interpretation of study results.

Sites / Locations

  • Arizona Urology Specialists
  • Loma Linda University Medical Center
  • American Institute of Research
  • Tower Urology
  • Genesis Research
  • Wichita Urology Group
  • Chesapeake Urology Research Associates
  • John Hopkins University
  • Chesapeake Urology Research Associates
  • The Brigham and Women's Hospital, Inc.
  • Michigan Urology
  • University of Missouri
  • Urology Center Las Vegas
  • New Jersey Urology
  • New Jersey Urology
  • Atlantic Health System
  • Great Lakes Physician dba WNY Urology Associates
  • AccuMed Research Associates
  • Manhattan Medical Research
  • NYU Langone Health
  • Mount Sinai
  • Premier Medical Group of the Hudson Valley PC
  • University of Rochester
  • Stony Brook Cancer Center
  • TriState Urologic Services PSC INC., dba The Urology Group
  • Clinical Research Solutions
  • Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
  • Penn State Health Milton S. Hershey Medical Center and College of Medicine
  • Urology Associates, P.C.
  • Houston Methodist Research Institute
  • Spokane Urology, P.S.
  • Ordensklinikum Linz GmbH Elisabethinen Hospital, Department of Urology
  • Salzburg Regional Hospital, University Hospital of Urology and Andrology
  • Medical University Vienna, Department of Urology
  • Hospital Wels-Grieskirchen, Department of Urology and Andrology
  • Multiprofile Hospital for Active Treatment - Blagoevgrad
  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
  • Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom
  • Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"
  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
  • University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv
  • University Multiprofile Hospital for Active Treatment, Plovdiv
  • Multiprofile Hospital for Active Treatment Park Hospital
  • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
  • Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
  • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
  • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"
  • Multiprofile Hospital for Active Treatment - Targovishte
  • Multiprofile Hospital for Active Treatment "Life Hospital" Burgas
  • Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology
  • Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
  • First Private Hospital Vratsa, Department of Urology
  • Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology
  • East Viru Central Hospital, Surgery Clinic
  • East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
  • West Tallinn Central Hospital Ltd., Department of Urology
  • North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
  • Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
  • LTD Central University Clinic After Academic N. Kipshidze
  • JSC Jerarsi, Department of Urology
  • LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department
  • LTD Gidmedi, Urology Department
  • LTD L. Managadze National Center of Urology, Department of Urology
  • LTD MMT Hospital, Urology Department
  • Pineo Medical Ecosystem Ltd., Department of Urology
  • Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department
  • Liepajas Regional Hospital, Urology Department
  • P. Stradins Clinical University Hospital, Center for Urology
  • LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
  • Daugavpils Regional Hospital, Urology Department
  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
  • Klaipeda University Hospital
  • National Cancer Institute
  • Vilnius University Hospital Santaros Klinikos
  • AKMED
  • SCM sp. z o.o. (LLC)
  • Clinical Research Center Limited liability company Medic-R Limited partnership
  • Mazovian Oncology Hospital, Subdepartment of Urology
  • Clinical Center of Serbia, Clinic of Urology
  • Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology
  • Clinical Hospital Center Zemun, Urology unit
  • Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis
  • Hospital del Mar
  • Hospital de Basurto
  • University Hospital Foundation Jimenez Diaz
  • University Hospital 12 de Octubre
  • La Paz University Hospital
  • Central University Hospital de Asturias (HUCA)
  • Navarra University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UGN-102

Arm Description

Patients will receive 6 once-weekly intravesical instillations of UGN-102.

Outcomes

Primary Outcome Measures

Complete response rate (CRR)
CRR is defined as the proportion of patients who achieved CR at the 3-month Visit.

Secondary Outcome Measures

Duration of response (DOR)
DOR is defined as the time from the date of evidence of CR at the 3-month Visit to the earliest date of recurrence or progression or death due to any cause, whichever occurred first.
Durable complete response (DCR) rate
DCR rate at scheduled disease assessment time points, defined as the proportion of patients who achieved CR at the 3-month Visit and maintained CR (ie, no detectable disease) up to that particular follow-up disease assessment.
Disease-free survival (DFS)
DFS in patients who achieved CR at the 3-month Visit, defined as the time from first dose to the earliest date of recurrence or progression or death due to any cause, whichever occurred first.
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology, serum chemistry, and urinalysis).
The number of patients with each type of event will be summarized.

Full Information

First Posted
February 7, 2022
Last Updated
September 28, 2023
Sponsor
UroGen Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05243550
Brief Title
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
Acronym
ENVISION
Official Title
A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
February 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UroGen Pharma Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This Phase 3, multinational, single-arm, multicenter study will evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).
Detailed Description
Eligible patients will receive 6 once-weekly intravesical instillations of UGN-102. All patients will return to the clinic approximately 3 months after the first instillation for determination of response to treatment. Assessment of response will be based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions by central pathology lab (if applicable), and interpretation of urine cytology by central pathology lab. Patients confirmed to have a complete response (CR) at the 3-month Visit, defined as having no detectable disease (NDD) in the bladder, will enter the Follow-up Period of the study. Patients confirmed to have a non-complete response (NCR) will undergo Investigator designated standard of care (SOC) treatment of remaining lesions and then enter the Follow-up Period of the study. During the Follow-up Period, patients will return to the clinic every 3 months for up to 24 months (ie, 27 months after the first instillation) for evaluation of response. Patients who remain disease free at the 27-month Visit will continue to return to the clinic every 6 months for up to 36 months (ie, 63 months after the first instillation) or until disease recurrence, disease progression, death, or the study is closed by the Sponsor, whichever occurs first. Patients confirmed to have a disease recurrence during the Follow-up Period or a disease progression at the 3-month Visit or during the Follow-up Period will undergo Investigator designated SOC treatment and have a separate End of Study (EOS) Visit performed. The timing of the EOS Visit will be approximately 3 months after SOC treatment of disease recurrence or progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
Keywords
Non-muscle invasive bladder cancer, Low grade non-muscle invasive bladder cancer, Intermediate risk non-muscle invasive bladder cancer, NMIBC, UGN-102, Mitomycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UGN-102
Arm Type
Experimental
Arm Description
Patients will receive 6 once-weekly intravesical instillations of UGN-102.
Intervention Type
Drug
Intervention Name(s)
UGN-102
Other Intervention Name(s)
UGN-102 (mitomycin) for intravesical solution
Intervention Description
UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder. The UGN-102 admixture for intravesical instillations contains 75 mg mitomycin in 56 mL admixture (1.33 mg mitomycin per 1 mL).
Primary Outcome Measure Information:
Title
Complete response rate (CRR)
Description
CRR is defined as the proportion of patients who achieved CR at the 3-month Visit.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Duration of response (DOR)
Description
DOR is defined as the time from the date of evidence of CR at the 3-month Visit to the earliest date of recurrence or progression or death due to any cause, whichever occurred first.
Time Frame
Up to 63 months
Title
Durable complete response (DCR) rate
Description
DCR rate at scheduled disease assessment time points, defined as the proportion of patients who achieved CR at the 3-month Visit and maintained CR (ie, no detectable disease) up to that particular follow-up disease assessment.
Time Frame
Up to 63 months
Title
Disease-free survival (DFS)
Description
DFS in patients who achieved CR at the 3-month Visit, defined as the time from first dose to the earliest date of recurrence or progression or death due to any cause, whichever occurred first.
Time Frame
Up to 63 months
Title
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology, serum chemistry, and urinalysis).
Description
The number of patients with each type of event will be summarized.
Time Frame
Up to 63 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol. Patient who has LG NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening. History of LG NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened. Has intermediate risk disease, defined as having 1 or 2 of the following: Presence of multiple tumors; Solitary tumor > 3 cm; Early or frequent recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial Screening Visit). Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening. Has adequate organ and bone marrow function as determined by routine laboratory tests as below: Leukocytes ≥ 3,000 per μL; Absolute neutrophil count ≥ 1,500 per μL; Platelets ≥ 100,000 per μL; Hemoglobin ≥ 9.0 g/dL; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 2.5 × ULN; Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min. Has an anticipated life expectancy of at least the duration of the trial. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment. Exclusion Criteria: Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year. History of HG bladder cancer (papillary or carcinoma in situ [CIS]) in the past 2 years. Known allergy or sensitivity to mitomycin that in the Investigator's opinion cannot be readily managed. Clinically significant urethral stricture that would preclude passage of a urethral catheter. History of: Neurogenic bladder; Active urinary retention; Any other condition that would prohibit normal voiding. Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC. Current tumor grading of T1. Concurrent upper tract urothelial carcinoma (UTUC). Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment. Is pregnant or breastfeeding. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the Investigator, the patient would be unable to comply with the protocol. History of prior treatment with an intravesical chemotherapeutic agent in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT. Has participated in a study with an investigational agent or device within 30 days of enrollment. Has previously participated in a study in which they received UGN-102. Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous basal cell or squamous cell carcinomas that can be treated locally are allowed. Has any other clinically significant medical or surgical condition that in the Investigator's opinion could compromise patient safety or the interpretation of study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandip Prasad, MD
Organizational Affiliation
Atlantic Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Urology Specialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Tower Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Genesis Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Wichita Urology Group
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
John Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
The Brigham and Women's Hospital, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Michigan Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Urology Center Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
New Jersey Urology
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
New Jersey Urology
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Great Lakes Physician dba WNY Urology Associates
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Stony Brook Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
TriState Urologic Services PSC INC., dba The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Clinical Research Solutions
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center and College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Urology Associates, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Spokane Urology, P.S.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Ordensklinikum Linz GmbH Elisabethinen Hospital, Department of Urology
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Salzburg Regional Hospital, University Hospital of Urology and Andrology
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medical University Vienna, Department of Urology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hospital Wels-Grieskirchen, Department of Urology and Andrology
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Multiprofile Hospital for Active Treatment - Blagoevgrad
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom
City
Lom
ZIP/Postal Code
3600
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment, Plovdiv
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Park Hospital
City
Plovdiv
ZIP/Postal Code
4109
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Targovishte
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Life Hospital" Burgas
City
Varna
ZIP/Postal Code
8008
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
Facility Name
First Private Hospital Vratsa, Department of Urology
City
Vratsa
ZIP/Postal Code
3001
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology
City
Yambol
ZIP/Postal Code
8600
Country
Bulgaria
Facility Name
East Viru Central Hospital, Surgery Clinic
City
Kohtla-Järve
ZIP/Postal Code
31025
Country
Estonia
Facility Name
East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
West Tallinn Central Hospital Ltd., Department of Urology
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
LTD Central University Clinic After Academic N. Kipshidze
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
JSC Jerarsi, Department of Urology
City
Tbilisi
Country
Georgia
Facility Name
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department
City
Tbilisi
Country
Georgia
Facility Name
LTD Gidmedi, Urology Department
City
Tbilisi
Country
Georgia
Facility Name
LTD L. Managadze National Center of Urology, Department of Urology
City
Tbilisi
Country
Georgia
Facility Name
LTD MMT Hospital, Urology Department
City
Tbilisi
Country
Georgia
Facility Name
Pineo Medical Ecosystem Ltd., Department of Urology
City
Tbilisi
Country
Georgia
Facility Name
Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department
City
Tbilisi
Country
Georgia
Facility Name
Liepajas Regional Hospital, Urology Department
City
Liepāja
ZIP/Postal Code
LV-3414
Country
Latvia
Facility Name
P. Stradins Clinical University Hospital, Center for Urology
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Daugavpils Regional Hospital, Urology Department
City
Riga
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Facility Name
Klaipeda University Hospital
City
Klaipėda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
National Cancer Institute
City
Vilnius
ZIP/Postal Code
LT-08660
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
AKMED
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Facility Name
SCM sp. z o.o. (LLC)
City
Kraków
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Clinical Research Center Limited liability company Medic-R Limited partnership
City
Poznań
ZIP/Postal Code
61-737
Country
Poland
Facility Name
Mazovian Oncology Hospital, Subdepartment of Urology
City
Wieliszew
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Clinical Center of Serbia, Clinic of Urology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Hospital Center Zemun, Urology unit
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
University Hospital Foundation Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
University Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
La Paz University Hospital
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Central University Hospital de Asturias (HUCA)
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Navarra University Hospital
City
Pamplona
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer

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