Bladder CancerPhase 4ABLE-42NCT06390111
A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.
A Phase 4 study testing nadofaragene firadenovec in people with Bladder Cancer and Ta/T1, run by Ferring Pharmaceuticals at 2 sites in United States.
Trial summary
In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered reinduction when entering the trial. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bladder Cancer, Ta/T1, CIS
- What is being tested?
- nadofaragene firadenovec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2024to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed, as documented, with CIS ± high-grade disease Ta/T1 and absence of progression after first dose of nadofaragene firadenovec within the last 5 months from instillation.
- Diagnosed, as documented, with:
- Low risk of disease progression as assessed at the discretion of the investigator
- Previous Bacillus Calmette Guerin (BCG) therapy (BCG exposed) with no maximum limit to the amount of BCG administered
Who cannot join
- Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive include but are not limited to:
- Presence of lymphovascular invasion and / or micropapillary disease as shown in the histology of the biopsy sample
- Subjects with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor
- Current and prior systemic or local therapy for bladder cancer since first dose of nadofaragene firadenovec
- Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non-interventional study does not apply) since first dose of nadofaragene firadenovec
- Clinically significant and unexplained elevated liver or renal function tests
- 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. Also subjects with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance are excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ferring Investigational Site
Atlanta, Georgia, 30328
Ferring Investigational Site
Little Rock, Arkansas, 72211
About this study
Official title: A Phase 4, Multi-center, Open Label Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.
In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered reinduction when entering the trial.
- Conditions
- Bladder Cancer, Ta/T1, CIS
- Being tested
- nadofaragene firadenovec
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nadofaragene firadenovecDrug
Also called Adstiladrin
The investigational medicinal product dose, concentration, and assessments are aligned with nadofaragene firadenovec US prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Nadofaragene Firadenovec | Experimental | Eligible subjects will receive nadofaragene firadenovec. This will be instilled quarterly in the bladder followed by quarterly disease assessments. Receives: Drug: nadofaragene firadenovec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment
Measured: at month 3
Secondary outcomes (10)
Maintenance of CR at months 6 after nadofaragene firadenovec retreatment
Measured: at 6 months after nadofaragene firadenovec retreatment
Maintenance of CR at months 9 after nadofaragene firadenovec retreatment
Measured: at 9 months after nadofaragene firadenovec retreatment
Maintenance of CR at months 12 after nadofaragene firadenovec retreatment
Measured: at 12 months after nadofaragene firadenovec retreatment
Durability of CR at months 6 after nadofaragene firadenovec retreatment
No evidence of CIS and/or high-grade Ta/T1
Measured: at 6 months after nadofaragene firadenovec retreatment
Durability of CR at months 9 after nadofaragene firadenovec retreatment
No evidence of CIS and/or high-grade Ta/T1
Measured: at 9 months after nadofaragene firadenovec retreatment
Durability of CR at months 12 after nadofaragene firadenovec retreatment
No evidence of CIS and/or high-grade Ta/T1
Measured: at 12 months after nadofaragene firadenovec retreatment
Muscle-invasive progression of disease up to month 12 after nadofaragene firadenovec retreatment
Measured: Up to12 months after nadofaragene firadenovec retreatment
Incidence of cystectomy
Measured: Up to 12 months after nadofaragene firadenovec retreatment
Time to cystectomy
Measured: Up to 12 months after nadofaragene firadenovec retreatment
Pathological staging at cystectomy
Measured: Up to 12 months after nadofaragene firadenovec retreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start17 Jun 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Why it stopped: Ferring decided to prioritize collection of ADSTILADRIN re-induction data in patients with HR BCG-unresponsive NMIBC who did not have a CR to the initial dose of ADSTILADRIN through data sources within the clinical setting including ABLE-22 and -41.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390111
- Sponsor's protocol ID
- 000439
- Acronym
- ABLE-42
- Status last verified
- Aug 2024
- First submitted
- 19 Apr 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multi-center, Open Label Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.
- ClinicalTrials.gov ID
- NCT06390111
- Acronym / sponsor ID
- ABLE-42 / 000439
- Conditions
- Bladder Cancer, Ta/T1, CIS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ferring decided to prioritize collection of ADSTILADRIN re-induction data in patients with HR BCG-unresponsive NMIBC who did not have a CR to the initial dose of ADSTILADRIN through data sources within the clinical setting including ABLE-22 and -41.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered reinduction when entering the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nadofaragene Firadenovec | Experimental | Drug: nadofaragene firadenovecEligible subjects will receive nadofaragene firadenovec. This will be instilled quarterly in the bladder followed by quarterly disease assessments. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed, as documented, with CIS ± high-grade disease Ta/T1 and absence of progression after first dose of nadofaragene firadenovec within the last 5 months from instillation.
- Diagnosed, as documented, with:
Key exclusion criteria (7 listed)
- Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive include but are not limited to:
- Current and prior systemic or local therapy for bladder cancer since first dose of nadofaragene firadenovec
- Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non-interventional study does not apply) since first dose of nadofaragene firadenovec
- Clinically significant and unexplained elevated liver or renal function tests
- 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. Also subjects with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nadofaragene firadenovecAlso: AdstiladrinThe investigational medicinal product dose, concentration, and assessments are aligned with nadofaragene firadenovec US prescribing information. | Drug | Nadofaragene Firadenovec |
Primary outcome
Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment
Time frame: at month 3
10 secondary outcomes
Maintenance of CR at months 6 after nadofaragene firadenovec retreatment
Time frame: at 6 months after nadofaragene firadenovec retreatment
Maintenance of CR at months 9 after nadofaragene firadenovec retreatment
Time frame: at 9 months after nadofaragene firadenovec retreatment
Maintenance of CR at months 12 after nadofaragene firadenovec retreatment
Time frame: at 12 months after nadofaragene firadenovec retreatment
Durability of CR at months 6 after nadofaragene firadenovec retreatment
Time frame: at 6 months after nadofaragene firadenovec retreatment
Durability of CR at months 9 after nadofaragene firadenovec retreatment
Time frame: at 9 months after nadofaragene firadenovec retreatment
Durability of CR at months 12 after nadofaragene firadenovec retreatment
Time frame: at 12 months after nadofaragene firadenovec retreatment
Muscle-invasive progression of disease up to month 12 after nadofaragene firadenovec retreatment
Time frame: Up to12 months after nadofaragene firadenovec retreatment
Incidence of cystectomy
Time frame: Up to 12 months after nadofaragene firadenovec retreatment
Time to cystectomy
Time frame: Up to 12 months after nadofaragene firadenovec retreatment
Pathological staging at cystectomy
Time frame: Up to 12 months after nadofaragene firadenovec retreatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nadofaragene firadenovec in people with Bladder Cancer and Ta/T1, run by Ferring Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment (time frame: at month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.