An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorCG Oncology, Inc.
About this trial
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 criteria
Qualifiers
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.
Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior to study treatment
Ineligible to receive radical cystectomy (medically unfit) or refusal of radical cystectomy according to Investigator assessment.
Disqualifiers
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 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.
Trial design
Treatments tested in this trial
- Cretostimogene Grenadenorepvec
- n-dodecyl-B-D-maltoside
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov