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The study has been updated to version v2.10.0 and now includes 8 locations, replacing the previous version v2.9.7.
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The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Prostate cancer MedlinePlus related topics: Prostate Cancer Drug Information available for: Pembrolizumab FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Non-Randomized Interventional Model : Sequential Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Part A: ADXS31-142 Participants received ADXS31-142 1 × 10^9 colony-forming units (CFU), 5 × 10^9 CFU, or 1 × 10^10 CFU intravenously (IV) every 3 weeks (Q3W) in a 12-week cycle for up to 24 months or until disease progression or discontinuation. Drug : ADXS31-142 ADXS31-142 IV infusion Experimental : Part B: ADXS31-142 + Pembrolizumab Participants received ADXS31-142 1 × 10^9 CFU) IV Q3W (in a 12-week cycle) in combination with 200 mg pembrolizumab IV Q3W for three times, with a fourth pembrolizumab dose 3 weeks later (in 12 week-cycles) for up to 24 months or until disease progression or discontinuation. Drug : ADXS31-142 ADXS31-142 IV infusion Drug : Pembrolizumab Pembrolizumab IV infusion Other Names: MK-3475 Primary Outcome Measures Outcome Measure Measure Description Time Frame Number of Participants With Treatment-Emergent Adverse Events An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Adverse events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication were considered 'treatment emergent'. From first dose up to 30 days after last dose (maximum duration: 108 weeks) Secondary Outcome Measures Outcome Measure Measure Description Time Frame Objective Response Rate (ORR) The objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 was defined as the number of participants with objective evidence of radiologic complete response (CR: disappearance of all target lesions) and partial response (PR: at least a 30% decrease in the sum of the longest diameters of target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions) as determined from investigator response assessments. Disease Control Rates are based upon confirmed events only. From screening until progression or death (maximum duration: 104 weeks) Objective Response Rate According to Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) The ORR according to irRECIST was defined as the number of participants with objective evidence of radiologic immune-related CR (irCR: Disappearance of all target lesions) and immune-related PR (irPR: At least 30% decrease in tumor burden compared with baseline) as determined from investigator response assessments. From screening until progression or death (maximum duration: 104 weeks) Progression-free Survival, Assessed by RECIST Version 1.1 Progression-free survival (PFS) was defined as the time from randomization until objective tumor progression based on response evaluation criteria in solid tumors (RECIST) version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method. From screening until progression or death (maximum duration: 104 weeks) Overall Survival Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method. Additional Relevant MeSH Terms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Prostatic Neoplasms Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Pembrolizumab Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Study Documents Provided by Advaxis, Inc. Study Protocol and Statistical Analysis Plan [ PDF , 18.23MB, 2017-04-21 ] Helpful Links Provided by Advaxis, Inc. Related Info Revision: v2.9.1.
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