Study on Reinduction Treatment with Nadofaragene Firadenovec for Patients with CIS ± High-grade Ta/T1 Bladder Cancer Not Responding to Initial Treatment

Sponsor: Ferring Pharmaceuticals

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06390111

Provider View

This clinical trial is offering a second round of treatment with Nadofaragene Firadenovec for patients with a specific type of bladder cancer (CIS ± high-grade Ta/T1) who did not respond to their first dose. The study aims to evaluate the effectiveness of this reinduction therapy.

Patient Parameters

Program Overview

This phase 4 study is for patients with non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS) with or without high-grade Ta/T1 disease. If these patients did not have a complete response to their first dose of Nadofaragene Firadenovec, they will be offered another round of treatment upon entering the trial. The goal is to see if this additional treatment can help control the cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with CIS ± high-grade Ta/T1 bladder cancer and no progression after the first dose of Nadofaragene Firadenovec within the last 5 months.
  • Considered to have a low risk of disease progression, as determined by the study doctor.
  • Previously treated with Bacillus Calmette Guerin (BCG) therapy, with no limit on the amount of BCG received.

Exclusion Criteria

  • Evidence of muscle-invasive or metastatic bladder cancer at the screening visit.
    • Includes signs like lymphovascular invasion or micropapillary disease in biopsy results.
    • T1 disease with hydronephrosis caused by the primary tumor.
  • Received any systemic or local therapy for bladder cancer since the first dose of Nadofaragene Firadenovec.
  • Participated in any investigational treatment for BCG-unresponsive NMIBC or other investigational drugs since the first dose of Nadofaragene Firadenovec.
  • Unexplained high liver or kidney function test results.
  • History of other cancers within the past 5 years, except for treated skin cancers or certain upper tract urothelial cancers after surgery. Patients with other genitourinary cancers under active surveillance are also excluded.

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