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This is an open-label, dose-escalation, non-randomized, phase I study in patients with histologically confirmed Stage III or IV melanoma and at least three metastatic cutaneous or subcutaneous lesions suitable for: intralesional (IL) injection (1 lesion), accessible for biopsy (1 lesion), and response evaluation by RECIST (v1.1) and modified RECIST (irRC) (1 lesion). The primary objective is to determine whether IL administration of BCG followed by intravenous (IV) infusion of ipilimumab is safe. Ipilimumab (YERVOY®) is the monoclonal anti-CTLA-4 antibody approved by the FDA and TGA as anticancer therapy for melanoma. Secondary objectives of the study are: a) clinical efficacy, to document whether this combination therapy induces tumour responses; and b) immunogenicity, to identify if the combination induces immune responses against the tumours. All patients will be included in the analysis of efficacy and immunogenicity.
Cohort 1 (9 patients with <10mm induration after tuberculin Purified Protein Derivative [PPD] test): Group 1 (3 patients) will receive one IL injection of 200 µl BCG containing 0.16 - 0.64 x 106 cfu followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks, starting on day 36. Group 2 (3 patients) and 3 (n=3) will receive 200 µl BCG containing 0.8 - 3.2 x 106 cfu and 4.0 -16.0 x 106 cfu, respectively, followed by the same ipilimumab regimen. Safety will be evaluated in this cohort.
Cohort 2 (up to 9 patients with ≥10mm induration after PPD test): Enrolment will start after the final patient in Cohort 1, Group 1 has reached study week 7. Then enrolment can proceed in parallel for Cohort 2 and Cohort 1 Groups 2 and 3. Patients will receive 0.16 -0.64 x 106 cfu BCG followed by four IV infusions of 3 mg/kg ipilimumab every 3 weeks, starting on day 36. Evaluation of safety in this cohort will be observational.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bacillus Calmette-Guérin (BCG) vaccine, Ipilimumab
Austin Health, LICR Melbourne Austin Branch
Ludwig Institute for Cancer Research
Published on BioPortfolio: 2014-08-27T04:00:41-0400
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