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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)
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
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