An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)

CRETO-EAP

This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC unresponsive to BCG.

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Inclusion Criteria: * Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the amount of prior BCG treatment, but maintenance BCG should be administered on a schedule consistent with standard induction-maintenance protocols. Specifically, the definition of BCG unresponsive CIS will also require the following: 1. Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease) within 12 months of last dose of adequate BCG treatment for HGUC. 2. Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 12 months of the initial qualifying dose of BCG. 3. Pathological confirmation of BCG unresponsive CIS within 16 weeks of study enrollment. 4. CIS specimen must be predominantly urothelial (transitional cell) and have less than 50% variant histology. 5. No maximum limit to the amount of BCG administered; however, there should be no more than 12 months between cycles of BCG. * Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment NOTE: T1 disease resection site must have biopsy evaluation of the prior resection site 2-12 weeks prior to initial study treatment. * Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment. * Acceptable baseline organ function Exclusion Criteria: * Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer. * Has had active autoimmune or inflammatory disease requiring systemic treatment within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of systemic treatment and is allowed. * Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of Day 1 * Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 6 weeks after the last study treatment.

{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}

2024-06-05