Procedures
tumor, death, toxicity, toxicities, DLT
DISEASE, DISEASE PROGRESSION, TUMOR
Study participants received MEDI0457 at a fixed dose of 7 mg intramuscularly with electroporation using the CELLECTRA device (Inovio) on weeks 1, 3, 7, 12, and every 8 weeks thereafter. Durvalumab was administered at 1500 mg intravenously every 4 weeks beginning at week 4 of study treatment. Radiographic assessments using computerized tomography or magnetic resonance imaging were performed for evaluation of treatment response every 8 weeks. Images of target lesions and metrics for tumor measurements were conducted according to a multimedia structured reporting system called ViSion, which allows for display of serial image findings in graphical disease timelines. The combination of durvalumab and MEDI0457 was continued until disease progression, unacceptable toxicity, withdrawal of informed consent, or death.For each cohort, dose-limiting toxicities (DLT) were monitored for every 6 patients, with early discontinuation of trial enrollment if Pr(DLT > 30%|data) > 0.90 using a prior beta (0.6, 1.4) for toxicity; that is, given the observed data, if the posterior probability is greater than 0.90 that the true DLT rate is higher than 30%, the trial will be discontinued early. Descriptive statistics were used to summarize toxicities associated with study treatment.