Brief Title
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Complete response rate (CRR)
Secondary Outcome
Duration of response (DOR)
Condition
Bladder Cancer
Intervention
UGN-102
Study Arms / Comparison Groups
UGN-102
Description: Patients will receive 6 once-weekly intravesical instillations of UGN-102.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
220
Start Date
March 1, 2022
Completion Date
February 2028
Primary Completion Date
February 2023
Eligibility Criteria
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.
[3:09 PM] Madlen Malinowski
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sandip Prasad, MD, +1 215-809-9828, [email protected]
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT05243550
Organization ID
BL011
Responsible Party
Sponsor
Study Sponsor
UroGen Pharma Ltd.
Study Sponsor
Sandip Prasad, MD, Principal Investigator, Atlantic Health System
Verification Date
June 2022