← Back to Search

Virus Therapy

Nadofaragene Firadenovec for Bladder Cancer (ABLE-42 Trial)

Phase 4
Recruiting
Research Sponsored by Ferring Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Current and prior systemic or local therapy for bladder cancer since first dose of nadofaragene firadenovec
Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months after nadofaragene firadenovec retreatment
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

"This trial is offering a second dose of medication to participants with a certain type of bladder cancer who did not respond well to the first dose they received before entering the trial."

Who is the study for?
This trial is for individuals with a type of bladder cancer called CIS, possibly alongside high-grade Ta/T1 disease. They should have already received one dose of nadofaragene firadenovec without disease progression but no response either, within the last 5 months. Participants must have had prior BCG therapy and be considered at low risk for disease progression.
What is being tested?
The study tests if giving another dose (reinduction) of nadofaragene firadenovec can be effective in patients who didn't respond to their first dose. It's specifically for those who've used this treatment commercially before joining the trial.
What are the potential side effects?
While specific side effects are not listed here, gene therapy treatments like nadofaragene firadenovec may cause immune reactions, flu-like symptoms, irritation at the injection site, and potential long-term risks which will be monitored.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received treatments for bladder cancer after my first dose of nadofaragene firadenovec.
Select...
My cancer has spread into muscle or beyond.
Select...
I have not taken experimental drugs for bladder cancer or any other condition after starting nadofaragene firadenovec.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months after nadofaragene firadenovec retreatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after nadofaragene firadenovec retreatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Durability of CR at months 12 after nadofaragene firadenovec retreatment
Durability of CR at months 6 after nadofaragene firadenovec retreatment
Durability of CR at months 9 after nadofaragene firadenovec retreatment

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nadofaragene FiradenovecExperimental Treatment1 Intervention
Eligible subjects will receive nadofaragene firadenovec. This will be instilled quarterly in the bladder followed by quarterly disease assessments.

Find a Location

Who is running the clinical trial?

Ferring PharmaceuticalsLead Sponsor
322 Previous Clinical Trials
1,242,251 Total Patients Enrolled
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
70 Previous Clinical Trials
1,158,568 Total Patients Enrolled
~17 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top