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. (ABLE-42)

Ferring

Status and phase: Withdrawn; Phase 4

Conditions: Bladder Cancer; CIS; Ta/T1

Treatments: Drug: nadofaragene firadenovec

Study type: Interventional

Funder types: Industry

Identifiers

NCT06390111

000439

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Nadofaragene Firadenovec

Experimental group

Description:

Eligible subjects will receive nadofaragene firadenovec. This will be instilled quarterly in the bladder followed by quarterly disease assessments.

Treatment:

Drug: nadofaragene firadenovec