Clinical Trial Details
An Expanded Access Program of Cretostimogene Grenadenorepvec in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG)
Overview
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Age Groups | Adult, Older Adult |
Inclusion Criteria:
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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:
- Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or HG T1 disease)
- Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 15 months of the initial qualifying dose of BCG.
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Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment
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Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
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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
- Replacement therapy is not considered an excluded form of systemic treatment and is allowed.
- Has received systemic anticancer therapy, including investigational agents, within 4 weeks of Day 1
- Is pregnant, currently breastfeeding or intending to breastfeed, beginning at Screening through 1 week after the last study treatment.
