A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer

The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).

Trial Details

NCT ID
NCT06545955
Phase
PHASE3
Sponsor
Ferring Pharmaceuticals
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Nadofaragene Firadenovec
  • Gemcitabine
  • Docetaxel
  • Pembrolizumab
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Diagnosed, as documented, with carcinoma in situ (CIS) ±Ta/T1 high-grade disease.
  • For T1 disease biopsies should contain muscle fibres.
  • Unresponsive to ≥2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last 12 months. BCG-unresponsive refers to participants with high-g…
  • Have received at least 2 courses of BCG within a 12 month period - defined as at least 5 of 6 induction BCG instillations and at least 2 of 3 insti…

For full eligibility, visit ClinicalTrials.gov.

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