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- Check4 days agoChange DetectedThe study has expanded to include 117 locations, and the website has been updated to version 2.10.0, replacing the previous version 2.9.7.SummaryDifference0.3%
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- Check30 days agoChange DetectedThe value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent change in the webpage content related to the study of ADXS11-001 in participants with High Risk Locally Advanced Cervical Cancer (AIM2CERV). This change may reflect updates or modifications to the study details or results.SummaryDifference0.1%
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- Check32 days agoChange DetectedThe value 'Show more Show more Show more Revision: v2.9.0' has recently changed to 'Show less Show less MedlinePlus related topics: Cervical Cancer FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Placebo Comparator : Placebo Participants with locally advanced cervical cancer at higher risk for recurrence (HRLACC) received ADXS11-001 matching placebo by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course placebo matching to either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase. Drug : Placebo Experimental : ADXS11-001 Participants with HRLACC received ADXS11-001 at a dose of 1x10^9 colony forming units (CFU) by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course of either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase. Drug : ADXS11-001 Primary Outcome Measures Outcome Measure Measure Description Time Frame Disease Free Survival (DFS) DFS was defined as the time from randomization until death or recurrence. The date of recurrence was defined as the date of the first time point when recurrence of disease was determined. The determination of recurrence should occur by definitive pathologic tissue confirmation (e.g., biopsy/fine needle aspirate). However, in those cases where it was not medically feasible to obtain a tissue sample then radiographic evidence, when confirmed by independent radiology review, was used to determine recurrence. From the time of randomization to recurrence or death (Maximum duration: 44.7 months) Secondary Outcome Measures Outcome Measure Measure Description Time Frame Number of Participants With Treatment Emergent Adverse Events Adverse event (AE): any untoward medical occurrence in a participant administered a study treatment & which did not necessarily have to have a causal relationship with the study treatment. An AE is, any unfavorable & unintended sign, 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. Any worsening of a pre-existing condition that was temporally associated with the use of study treatment. AE with onset dates on or after the first dose of study treatment were considered treatment emergent. From first dose of study drug until end of study (Up to 44.7 months) Overall Survival (OS) Overall survival was defined as the time from the date of randomization until death due to any cause. From the date of randomization until death due to any cause (Maximum duration: 44.7 months) Additional Relevant MeSH Terms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Uterine Cervical Neoplasms 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 , 2.71MB, 2020-12-07 ] Revision: v2.9.1SummaryDifference27%
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