Trial Title:
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
NCT ID:
NCT06331299
Condition:
Bladder Cancer
Urothelial Carcinoma
Urothelial Carcinoma Bladder
Conditions: Official terms:
Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Non-Muscle Invasive Bladder Neoplasms
Mitomycins
Mitomycin
Conditions: Keywords:
Non-muscle invasive bladder cancer
Low-grade non-muscle invasive bladder cancer
Intermediate-risk non-muscle invasive bladder cancer
NMIBC
UGN-103
UGN-102
Mitomycin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
UGN-103
Description:
UGN-103 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-103 allow for local administration of mitomycin as a liquid under
chilled conditions, with subsequent conversion to a semi-solid gel depot following
instillation into the bladder.
Arm group label:
UGN-103
Other name:
UGN-103 (mitomycin) for intravesical solution
Summary:
This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of
UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients
with low-grade non-muscle invasive bladder cancer (LG-NMIBC).
Detailed description:
Eligible patients will be treated with UGN-103 once weekly for 6 weeks (a total of 6
doses).
Efficacy will be assessed by the complete response rate (CRR) at the 3-month Visit
(approximately 3 months after the first instillation). Response will be determined 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 who 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.
During the Follow-up Period, patients will return to the clinic every 3 months for
evaluation of response. Patients will remain on study until disease recurrence, disease
progression, death, or the last patient completes 12 months of follow-up (ie, 15 months
after the first instillation), whichever occurs first.
Patients who have a non-complete response (NCR) at the 3-month Visit will undergo
investigator designated standard of care (SOC) and have a separate End of Study (EOS)
Visit performed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Provide 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 at least 1 prior episode of NMIBC. 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:
- Leukocytes ≥ 3,000/μL.
- Absolute neutrophil count ≥ 1,500/μL.
- Platelets ≥ 100,000/μL.
- Hemoglobin ≥ 9.0 g/dL.
- Total bilirubin ≤ 1.5 × 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 the previous 1 year.
2. History of HG bladder cancer (papillary or carcinoma in situ) in the past 2 years.
3. Known allergy or sensitivity to any component of the study treatment (including
excipients) 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 stage 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
transurethral resection of bladder tumors (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.
17. Where applicable per country regulation, the patient must not be currently committed
to an institution by virtue of an order issued by either judicial or administrative
authorities.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Genesis Research, LLC
Address:
City:
San Diego
Zip:
92123
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Amirali Salmasi, MD
Email:
Principal Investigator
Facility:
Name:
Great Lakes Physician dba WNYU
Address:
City:
Cheektowaga
Zip:
14225
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Kent Chevli, MD
Email:
Principal Investigator
Facility:
Name:
AccuMed Research Associates
Address:
City:
Garden City
Zip:
11530
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mitchell Efros, MD
Email:
Principal Investigator
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Abhishek Srivastava, MD
Email:
Principal Investigator
Facility:
Name:
Urology Associates P.C. - Nashville
Address:
City:
Nashville
Zip:
37209-4035
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Gautam Jayram, MD
Email:
Principal Investigator
Start date:
August 29, 2024
Completion date:
March 2026
Lead sponsor:
Agency:
UroGen Pharma Ltd.
Agency class:
Industry
Source:
UroGen Pharma Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331299
