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Study identifier: NCT06545955 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Non-muscle Invasive Bladder Cancer With Carcinoma in Situ  ·  Sponsor: Ferring Pharmaceuticals

PhasePhase 3
Planned participants250
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Ferring Pharmaceuticals  ·  833-548-1402 (US/Canada)  ·  disclosure@ferring.com

Ferring Pharmaceuticals  ·  +1862-286-5200 (not US/Canada)  ·  disclosure@ferring.com

Always discuss trial participation with your own doctor first.

Locations (76)

Center for NeurosciencesTucson, Arizona, United StatesRecruiting
Arkansas Urology, North Little RockLittle Rock, Arkansas, United StatesRecruiting
American Institute of ResearchLos Angeles, California, United StatesRecruiting
USC Kenneth Norris Jr Cancer HospitalLos Angeles, California, United StatesRecruiting
University of California, IrvineOrange, California, United StatesRecruiting
Genesis Research, LLC - San DiegoSan Diego, California, United StatesRecruiting
Advent HealthDenver, Colorado, United StatesRecruiting
Colorado Urology - St. Anthony Hospital CampusLakewood, Colorado, United StatesRecruiting
Yale School of MedicineNew Haven, Connecticut, United StatesRecruiting
Medstar Georgetown University HospitalWashington D.C., District of Columbia, United StatesRecruiting
Sarasota Memorial Healthcare SystemSarasota, Florida, United StatesRecruiting
Emory UniversityAtlanta, Georgia, United StatesRecruiting

+ 64 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06545955