Bladder Cancer Clinical Trial
Official title:
An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC unresponsive to BCG.
All participants will be assigned the same treatment schedule. Participants will receive an induction course and, if there is no disease recurrence at Week 13, participants will receive a cycle of 3 weekly treatments up to Week 15. If there is persistent HG Ta and/or CIS at Week 13, participants may receive a second induction course. If there is no disease present thereafter, participants will receive 3 weekly treatment cycles every 12 weeks through Month 12. After Month 12, participants will receive 3 weekly treatment cycles every 6 months through the last treatment cycle at Month 24, or until discontinuation from the study treatment. Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 12 weeks and CTU/MRU every 24 weeks, for up to 2 years. ;
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|---|---|---|---|
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