Study on Nadofaragene Firadenovec Alone or with Chemotherapy/Immunotherapy for High-Grade Bladder Cancer Unresponsive to BCG
Sponsor: Ferring Pharmaceuticals
ClinicalTrials ID:NCT06545955
This clinical trial is testing a new treatment using nadofaragene firadenovec, either alone or combined with chemotherapy or immunotherapy, for patients with high-grade bladder cancer that hasn't responded to BCG treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to evaluate the safety and effectiveness of a treatment called nadofaragene firadenovec, which is given directly into the bladder. This treatment will be tested alone or in combination with chemotherapy or immunotherapy in patients with high-grade non-muscle invasive bladder cancer (NMIBC) that has not responded to BCG therapy. Previous research showed promising results, with over half of the patients achieving a complete response after three months.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with carcinoma in situ (CIS) or high-grade Ta/T1 bladder cancer.
- Cancer has not responded to at least two courses of BCG treatment in the past year.
- Cancer returned within 12 months after BCG treatment or within 6 months for high-grade Ta/T1 NMIBC.
- Received at least two courses of BCG, with specific requirements for the number of treatments.
- All visible tumors must be removed before starting the trial.
- ECOG performance status of 2 or less.
- Aged 18 years or older.
- Available for the entire duration of the trial.
- Life expectancy of more than 2 years.
- No cancer in the upper urinary tract or prostatic urethra, confirmed by recent imaging tests.
Exclusion Criteria
- Evidence of muscle-invasive or metastatic bladder cancer at screening.
- Certain high-risk features in biopsy samples, such as lymphovascular invasion or specific types of cancer cells.
- Current systemic treatment for bladder cancer, except for the study treatment.
- Recent participation in other clinical trials for BCG-unresponsive NMIBC.
- Previous pelvic radiation therapy within the last 5 years.
- Previous treatment with nadofaragene firadenovec.
- Previous systemic therapy for bladder cancer.
- Previous intravesical chemotherapy for BCG-unresponsive NMIBC.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ferring Investigational Site | 93720 | Fresno | California |
| Ferring Investigational Site | 90017 | Los Angeles | California |
| Ferring Investigational Site | 06519 | New Haven | Connecticut |
| Ferring Investigational Site | 30322 | Atlanta | Georgia |
| Ferring Investigational Site | 48084 | Troy | Michigan |
| Ferring Investigational Site | 12603 | Poughkeepsie | New York |
| Ferring Investigational Site | 19004 | Bala-Cynwyd | Pennsylvania |
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