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A phase 2, randomised, multi-centre, open label trial to evaluate the safety and efficacy of intravesical nadofaragene firadenovec alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in subjects with high-grade Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC)

Cancer Center
Status
In recruitment
headquarters
Pamplona/Madrid
Early phase

Technical Summary

  • A PHASE 2, RANDOMISED, MULTI-CENTRE, OPEN LABEL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVESICAL NADOFARAGENE FIRADENOVEC ALONE OR IN COMBINATION WITH CHEMOTHERAPY (GEMCITABINE AND DOCETAXEL) OR IMMUNOTHERAPY (PEMBROLIZUMAB) IN SUBJECTS WITH HIGH-GRADE BACILLUS CALMETTE-GUERIN (BCG) UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)
  • Code EudraCT: 2024-512177-27-00
  • Protocol number: 000434
  • Promoter: Ferring Pharmaceuticals
  • Molecule/Drug: nadofaragene firadenovec intravesical
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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