Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer (ABLE-32)

Ferring

Status and phase: Enrolling; Phase 3

Conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer

Treatments: Drug: Nadofaragene Firadenovec

Study type: Interventional

Funder types: Industry

Identifiers

NCT06510374

U1111-1284-0685 (Other Identifier)

000423

Details and patient eligibility

About

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

Enrollment: 454 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

• Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:

  • Recurrence within 1 year, low-grade Ta

  • Solitary low-grade Ta >3 cm

  • Low-grade Ta, multifocal

  • Solitary high-grade Ta, ≤3 cm

  • Low-grade T1

    • Restage TURBT may be done at the discretion of the investigator

Exclusion criteria

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

High risk NMIBC defined as:

• High-grade T1
• Any recurrent, high-grade Ta
• High-grade Ta >3 cm (or multifocal)
• Any carcinoma in situ (CIS)
• Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
• Any variant histology
• Any prostatic urethral involvement

Low risk NMIBC defined as:

• First occurrence of low-grade solitary Ta ≤3 cm
• Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence
• Papillary urothelial neoplasm of low malignant potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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454 participants in 2 patient groups

Arm 1 Nadofaragene Firadenovec

Experimental group

Description:

Participants in the nadofaragene firadenovec arm will receive quarterly instillations with nadofaragene firadenovec for 24 months. For these subjects, the disease evaluation visits will occur within 2 weeks prior to the investigation medicinal products instillation visits.

Treatment:

Drug: Nadofaragene Firadenovec

Arm 2 - Observation

No Intervention group

Description:

Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period. .