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Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

ConditionIntermediate Risk Non-Muscle Invasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFerring Pharmaceuticals

About this trial

A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology [SUO] Guideline (2020)

Recurrence within 1 year, low-grade Ta

Solitary low-grade Ta >3 cm

Low-grade Ta, multifocal

Disqualifiers

Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit

High-grade T1

Any recurrent, high-grade Ta

High-grade Ta >3 cm (or multifocal)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nadofaragene Firadenovec

    Drug

    Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.

Treatment groups

454 Participants
are divided into 2 treatment groups
Group A: Arm 1 Nadofaragene FiradenovecExperimental treatment 1 intervention
Group B: Arm 2 - ObservationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recurrence Free survival

Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period.

Time frame
24 months

Secondary outcomes

1

Adverse Events

Frequency and intensity of adverse events will be recorded from the signed informed consent for participation in the trial up to month 24

Time frame
up to 24 months
2

Recurrence Free Survival at 12 Months

Recurrence free survival at 12 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 12 months

Time frame
12 months
3

Recurrence Free Survival at 24 Months

Recurrence free survival at 24 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 24 months

Time frame
24 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ferring Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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