Phase I Study of Intralesional Bacillus Calmette-Guerin (BCG) Followed by Ipilimumab in Advanced Metastatic Melanoma
Status:
Terminated
Trial end date:
2015-08-17
Target enrollment:
Participant gender:
Summary
This was a Phase 1, open-label, dose-escalation, single-center study in patients with
histologically confirmed Stage III or IV melanoma and at least 3 metastatic cutaneous or
subcutaneous lesions that were suitable and accessible for intralesional (IL) injection (1
lesion), biopsy (1 lesion), and response evaluation (1 lesion). The primary objective was to
determine the safety of IL administration of bacillus Calmette-Guerin (BCG) followed by oral
dosing with an antibiotic (isoniazid) and intravenous (IV) infusions of ipilimumab. Secondary
objectives were to evaluate the clinical efficacy (induction of tumor response) and
immunogenicity (induction of immune response against the tumors) of the combination regimen.