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The study has been updated to version v2.10.0, indicating a new release with potentially significant changes from the previous version v2.9.7.
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32 days ago
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The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less Genetic and Rare Diseases Information Center resources: Esophageal Cancer Drug Information available for: Pembrolizumab FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Pembrolizumab Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Drug : Pembrolizumab Immune checkpoint inhibitor Other Names: Keytruda Primary Outcome Measures Outcome Measure Measure Description Time Frame Overall Response Rate (ORR) The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Disease was evaluated each cycle on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 2.1 months with a maximum of 14.9 months. Secondary Outcome Measures Outcome Measure Measure Description Time Frame Median Progression-free Survival (PFS) Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Disease was evaluated each cycle on treatment and in long-term follow-up every 12 weeks for up to 5 years. Maximum follow-up in this study cohort was 28.9 months Median Overall Survival (OS) OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. Disease was evaluated each cycle on treatment and in long-term follow-up every 12 weeks for up to 5 years. Maximum follow-up in this study cohort was 38.7 months. Number of Patients Experiencing Grade 3-4 Treatment-Related Toxicity All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Outcome defined as the number of patients experiencing at least one treatment-related grade 3-4 AE of any type during the time of observation. Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort was 2.1 months with maximum of 14.9 months. Keywords Provided by Peter Enzinger, MD, Dana-Farber Cancer Institute Esophageal Cancer Additional Relevant MeSH Terms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Carcinoma, Squamous Cell Neoplasms, Squamous Cell Esophageal Neoplasms Esophageal Squamous Cell Carcinoma 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 Peter Enzinger, MD, Dana-Farber Cancer Institute Study Protocol and Statistical Analysis Plan [ PDF , 2.06MB, 2019-02-26 ] Revision: v2.9.1'
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