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Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
FE 999326
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

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

Inclusion Criteria: Have at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only Ta/T1 high-grade disease with concomitant CIS or Ta/T1 high-grade disease without concomitant CIS Subjects who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. Life expectancy >2 years, in the opinion of the investigator Eastern Cooperative Oncology Group (ECOG) status 2 or less Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra Subjects with prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) <10 ng/dL Exclusion Criteria: Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit. Current systemic therapy for bladder cancer Current or prior investigational treatment for BCG unresponsive NMIBC or any other investigational drug within 1 month prior to screening Current or prior pelvic external beam radiotherapy within 5 years of entry Use of other adenovirus vector medications, including COVID-19 vaccines, within 2 weeks before and after instillation History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. Subjects who cannot hold instillation for 1 hour Subjects who cannot tolerate intravesical dosing or intravesical surgical manipulation Intravesical therapy within 8 weeks prior to beginning trial treatment, with the exception of: Cytotoxic agents when administered as a single instillation immediately following a TURBT procedure Previous intravesical BCG therapy Systemic immunosuppressive therapy within 3 months prior to screening

Sites / Locations

  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FE 999326

Arm Description

Outcomes

Primary Outcome Measures

Whether or not a subject with CIS (with or without concomitant high-grade Ta or T1 papillary disease) responds to treatment, defined as complete response at any time after first administration of FE 999326
A subject with CIS (with or without concomitant high-grade Ta or T1 papillary disease) has achieved a complete response at an efficacy assessment if urine cytology is negative and there are no lesions on cystoscopy. If biopsy of the bladder is performed, this must be negative.

Secondary Outcome Measures

Duration of complete response in subjects with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who show a complete response at any time after first administration of FE 999326
Whether or not a subject with high-grade Ta or T1 papillary disease (without concomitant CIS) responds to treatment, defined as absence of recurrence of high-grade disease
Duration of event-free survival in subjects with high-grade Ta or T1 papillary disease (without concomitant CIS) and in subjects with CIS (with or without papillary disease)
Incidence of cystectomy
Time to cystectomy
Overall survival
Concentration of FE 999326-specific DNA levels in urine
Type, incidence, relatedness and severity of treatment emergent adverse events

Full Information

First Posted
December 21, 2022
Last Updated
October 17, 2023
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05704244
Brief Title
Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
Official Title
A Phase 3, Open Label Trial to Evaluate the Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
December 27, 2024 (Anticipated)
Study Completion Date
December 27, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the safety and efficacy of FE 999326 in Japanese subjects with high-grade, BCG unresponsive NMIBC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
FE 999326
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FE 999326
Other Intervention Name(s)
nadofaragene firadenovec
Intervention Description
75 mL FE 999326 (3 x 10^11 vp/mL) of sterile suspension instilled once every 3 months into the bladder via a urinary catheter
Primary Outcome Measure Information:
Title
Whether or not a subject with CIS (with or without concomitant high-grade Ta or T1 papillary disease) responds to treatment, defined as complete response at any time after first administration of FE 999326
Description
A subject with CIS (with or without concomitant high-grade Ta or T1 papillary disease) has achieved a complete response at an efficacy assessment if urine cytology is negative and there are no lesions on cystoscopy. If biopsy of the bladder is performed, this must be negative.
Time Frame
At Month 12 assessment
Secondary Outcome Measure Information:
Title
Duration of complete response in subjects with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who show a complete response at any time after first administration of FE 999326
Time Frame
Up to 5 years
Title
Whether or not a subject with high-grade Ta or T1 papillary disease (without concomitant CIS) responds to treatment, defined as absence of recurrence of high-grade disease
Time Frame
Up to 4 years
Title
Duration of event-free survival in subjects with high-grade Ta or T1 papillary disease (without concomitant CIS) and in subjects with CIS (with or without papillary disease)
Time Frame
Up to 5 years
Title
Incidence of cystectomy
Time Frame
Up to 4 years
Title
Time to cystectomy
Time Frame
Up to 4 years
Title
Overall survival
Time Frame
Up to 5 years
Title
Concentration of FE 999326-specific DNA levels in urine
Time Frame
Up to day 1 of month 4 after start of treatment; and 3, 6, 9 and 12 months after last dose (up to 5 years after start of treatment)
Title
Type, incidence, relatedness and severity of treatment emergent adverse events
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only Ta/T1 high-grade disease with concomitant CIS or Ta/T1 high-grade disease without concomitant CIS Subjects who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. Life expectancy >2 years, in the opinion of the investigator Eastern Cooperative Oncology Group (ECOG) status 2 or less Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra Subjects with prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) <10 ng/dL Exclusion Criteria: Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit. Current systemic therapy for bladder cancer Current or prior investigational treatment for BCG unresponsive NMIBC or any other investigational drug within 1 month prior to screening Current or prior pelvic external beam radiotherapy within 5 years of entry Use of other adenovirus vector medications, including COVID-19 vaccines, within 2 weeks before and after instillation History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. Subjects who cannot hold instillation for 1 hour Subjects who cannot tolerate intravesical dosing or intravesical surgical manipulation Intravesical therapy within 8 weeks prior to beginning trial treatment, with the exception of: Cytotoxic agents when administered as a single instillation immediately following a TURBT procedure Previous intravesical BCG therapy Systemic immunosuppressive therapy within 3 months prior to screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Global Clinical Compliance
Phone
+1 833-548-1402 (US/Canada)
Email
DK0-Disclosure@ferring.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Clinical Compliance
Phone
+1 862-286-5200 (outside US)
Email
DK0-Disclosure@ferring.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ferring Investigational Site
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Hakodate-shi
State/Province
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Hitachi-shi
State/Province
Ibaraki
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Tsukuba-shi
State/Province
Ibaraki
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Nankoku-shi
State/Province
Kochi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Tsu-shi
State/Province
Mie
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Kashihara-shi
State/Province
Nara
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Okayama-shi
State/Province
Okayama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Takatsuki-shi
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Mitaka-shi
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Toyama-shi
State/Province
Toyama
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)

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