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Brief Title: UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer

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

INTRODUCTION

  • Org Study ID: BL011
  • Secondary ID: N/A
  • NTC ID: NCT05243550
  • Sponsor: UroGen Pharma Ltd.

DESCRIPTION

To learn more about the ENVISION study and see the most current and accurate list of study sites and contacts please visit: https://clinicaltrials.gov/ct2/show/NCT05243550

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.

  • Overall Status
    Recruiting
  • Start Date
    March 1, 2022
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete response rate (CRR)

Primary Outcome 1 - Timeframe: 3 months

CONDITION

  • Bladder Cancer
  • Urothelial Carcinoma
  • Urothelial Carcinoma Bladder

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Sandip Prasad, MD

Role: Principal Investigator

Affiliation: Atlantic Health System

Overall Contact

Name: Sandip Prasad, MD

Phone: +1 215-809-9828, +1 646-844-6084

Email: christy.obercian@urogen.com, jessica.walker@urogen.com

LOCATION

Facility Status Contact
Facility: Arizona Urology Specialists
Tucson, Arizona 85704
United States
Status: Recruiting Contact: Contact
Kalpesh Patel, MD
520-784-7019
kpatel@aiurology.com
Facility: Loma Linda University Medical Center
Loma Linda, California 92350
United States
Status: Recruiting Contact: Principal Investigator
Kalpesh Patel, MD
909-558-0702
bhu@llu.edu
Facility: American Institute of Research
Los Angeles, California 90017
United States
Status: Recruiting Contact: Contact
Brian Hu, MD
213-481-7142
jkowalczyk@aireasearch.us
Facility: Tower Urology
Los Angeles, California 90048
United States
Status: Recruiting Contact: Principal Investigator
Brian Hu, MD
310-854-9898
josephsond@towerurology.com
Facility: Wichita Urology Group
Wichita, Kansas 67226
United States
Status: Recruiting Contact: Contact
Jennifer Linehan, MD
317-274-1791
cgerler@iu.edu
Facility: Chesapeake Urology Research Associates
Baltimore, Maryland 21204
United States
Status: Recruiting Contact: Contact
Jennifer Linehan, MD
316-636-6141
fjoudi@wichitaurology.com
Facility: John Hopkins University
Baltimore, Maryland 21218
United States
Status: Recruiting Contact: Principal Investigator
Piyush Agarwal, MD
316-636-6141
aho@wichitaurology.com
Facility: Chesapeake Urology Research Associates
Hanover, Maryland 21076
United States
Status: Recruiting Contact: Contact
Piyush Agarwal, MD
410-825-5454
bneuman@chesuro.com
Facility: Michigan Urology
Troy, Michigan 48084
United States
Status: Recruiting Contact: Contact
Courtney Dhondt
651-999-6800
rdcura@chesuro.com
Facility: University of Missouri
Columbia, Missouri 65212
United States
Status: Recruiting Contact: Contact
Amanda Ho
702-212-3428
Hafronj@michiganurology.com
Facility: Urology Center Las Vegas
Las Vegas, Nevada 89144
United States
Status: Recruiting Contact: Contact
Fadi Nabih Joudi, MD
856-673-1613
amilbank@mnurology.com
Facility: Atlantic Health System
Morristown, New Jersey 07960
United States
Status: Recruiting Contact: Contact
Rian Dickstein, MD
973-437-6744
gbrown@njurology.com
Facility: Great Lakes Physician dba WNY Urology Associates
Cheektowaga, New York 14225
United States
Status: Recruiting Contact: Principal Investigator
Mark Preston
516-746-2190
cwright@njurology.com
Facility: AccuMed Research Associates
Garden City, New York 11530
United States
Status: Recruiting Contact: Contact
Jason Hafron
516-746-2190
sandip.prasad@atlantichealth.org
Facility: Manhattan Medical Research
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Aaron Milbank
212-480-3333
kchevli@wnyurology.com
Facility: Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York 12603
United States
Status: Recruiting Contact: Principal Investigator
Michael Verni, MD
(513) 841-7555
william.huang@NYUMC.org
Facility: Stony Brook Cancer Center
Stony Brook, New York 11794
United States
Status: Recruiting Contact: Principal Investigator
Gordon A Brown, DO
610-667-0458
john.sfakianos@mountsinai.org
Facility: TriState Urologic Services PSC INC., dba The Urology Group
Cincinnati, Ohio 45212
United States
Status: Recruiting Contact: Principal Investigator
Christopher Wright, MD
713-441-6455
jacobj@upstate.edu
Facility: Clinical Research Solutions
Middleburg Heights, Ohio 44130
United States
Status: Recruiting Contact: Contact
Sandip Prasad, MD

wcorbett@urologygroup.com
Facility: Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Sandip Prasad, MD

Dr.lgervasi@crssites.com
Facility: Urology Associates, P.C.
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Kent Chevli, MD

daniel.lee4@pennmedicine.upenn.edu
Facility: Spokane Urology, P.S.
Spokane, Washington 99202
United States
Status: Recruiting Contact: Contact
Mitchell Efros, MD

rsatkunasiva@houstonmethodist.org
Facility: Multiprofile Hospital for Active Treatment - Blagoevgrad
Blagoevgrad, 2700
Bulgaria
Status: Recruiting Contact: Principal Investigator
William Huang, MD

Pearce_Research@spokaneurology.com
Facility: Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology
Gabrovo, 5300
Bulgaria
Status: Recruiting Contact: Contact
William Huang, MD

Facility: Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom
Lom, 3600
Bulgaria
Status: Recruiting Contact: Principal Investigator
William Huang, MD

Facility: Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"
Montana, 3400
Bulgaria
Status: Recruiting Contact: Contact
John Sfakianos

Facility: University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic
Pleven, 5800
Bulgaria
Status: Recruiting Contact: Contact
Evan Goldfischer

Facility: University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology
Pleven, 5800
Bulgaria
Status: Recruiting Contact: Contact
William Tabayoyong

Facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv
Plovdiv, 4002
Bulgaria
Status: Recruiting Contact: Contact
David Golombos, MD

Facility: University Multiprofile Hospital for Active Treatment, Plovdiv
Plovdiv, 4003
Bulgaria
Status: Recruiting Contact: Contact
David Golombos, MD

Facility: Multiprofile Hospital for Active Treatment Park Hospital
Plovdiv, 4109
Bulgaria
Status: Recruiting Contact: Principal Investigator
Chris Pieczonka

Facility: University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology
Ruse, 7000
Bulgaria
Status: Recruiting Contact: Contact
Joseph Jacob

Facility: Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology
Shumen, 9700
Bulgaria
Status: Recruiting Contact: Contact
Marc Pliskin, DO

Facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic
Sofia, 1606
Bulgaria
Status: Recruiting Contact: Contact
Marc Pliskin, DO

Facility: University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"
Stara Zagora, 6000
Bulgaria
Status: Recruiting Contact: Principal Investigator
Lawrence Gervasi

Facility: Multiprofile Hospital for Active Treatment - Targovishte
Targovishte, 7700
Bulgaria
Status: Recruiting Contact: Contact
Lawrence Gervasi, MD

Facility: Multiprofile Hospital for Active Treatment "Life Hospital" Burgas
Varna, 8008
Bulgaria
Status: Recruiting Contact: Principal Investigator
Laurence Belkoff, DO

Facility: Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology
Varna, 9000
Bulgaria
Status: Recruiting Contact: Contact
Laurence Belkoff, DO

Facility: Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic
Varna, 9002
Bulgaria
Status: Recruiting Contact: Principal Investigator
Jay Raman, MD

Facility: First Private Hospital Vratsa, Department of Urology
Vratsa, 3001
Bulgaria
Status: Recruiting Contact: Contact
Jay Raman, MD

Facility: Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology
Yambol, 8600
Bulgaria
Status: Recruiting Contact: Principal Investigator
Daniel Lee

Facility: East Viru Central Hospital, Surgery Clinic
Kohtla-Järve, 31025
Estonia
Status: Recruiting Contact: Contact
David Morris, MD

Facility: East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology
Tallinn, 10138
Estonia
Status: Recruiting Contact: Contact
David Morris, MD

Facility: West Tallinn Central Hospital Ltd., Department of Urology
Tallinn, 10617
Estonia
Status: Recruiting Contact: Principal Investigator
Brian Mazzarella, MD

Facility: North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre
Tallinn, 13419
Estonia
Status: Recruiting Contact: Contact
Raj Satkunasivam

Facility: Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation
Tartu, 50406
Estonia
Status: Recruiting Contact: Contact
Shane Pearce

Facility: LTD Central University Clinic After Academic N. Kipshidze
Tbilisi, 0160
Georgia
Status: Recruiting Contact: Contact
Petar Uzunov, MD

Facility: JSC Jerarsi, Department of Urology
Tbilisi, LV-3414
Georgia
Status: Recruiting Contact: Contact
Petar Uzunov, MD

Facility: LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department
Tbilisi, LV-1002
Georgia
Status: Recruiting Contact: Principal Investigator
Georgi Atanasov, MD

Facility: LTD Gidmedi, Urology Department
Tbilisi, LV-1038
Georgia
Status: Recruiting Contact: Contact
Georgi Atanasov, MD

Facility: LTD L. Managadze National Center of Urology, Department of Urology
Tbilisi, LV-5417
Georgia
Status: Recruiting Contact: Principal Investigator
Sasho Tsvetkov, MD

Facility: LTD MMT Hospital, Urology Department
Tbilisi, 11000
Georgia
Status: Recruiting Contact: Contact
Sasho Tsvetkov, MD

Facility: Pineo Medical Ecosystem Ltd., Department of Urology
Tbilisi, 11080
Georgia
Status: Recruiting Contact: Principal Investigator
Georgi Chakarov, MD

Facility: Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department
Tbilisi, 11080
Georgia
Status: Recruiting Contact: Contact
Georgi Chakarov, MD

Facility: Liepajas Regional Hospital, Urology Department
Liepāja, 34000
Latvia
Status: Recruiting Contact: Principal Investigator
Nikolay Kolev, MD

Facility: P. Stradins Clinical University Hospital, Center for Urology
Riga,
Latvia
Status: Recruiting Contact: Contact
Nikolay Kolev, MD

Facility: LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology
Riga,
Latvia
Status: Recruiting Contact: Principal Investigator
Assoc. Prof. Boyan Atanasov, MD

Facility: Daugavpils Regional Hospital, Urology Department
Riga,
Latvia
Status: Recruiting Contact: Contact
Assoc. Prof. Boyan Atanasov, MD

Facility: Clinical Center of Serbia, Clinic of Urology
Belgrade,
Serbia
Status: Recruiting Contact: Principal Investigator
Petar Antonov, MD