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- Check4 days agoChange DetectedThe study has been updated to version v2.10.0, with three locations now included, replacing the previous version v2.9.7.SummaryDifference0.4%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less 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 Interventional Model Description: This is a multi-centre, single arm phase 2 study of Pembrolizumab (Keytruda™ or MK-3475) in treatment naïve patients with poor prognosis carcinoma of unknown primary site (CUP). Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Arm 1 - Pembrolizumab Arm 1 - Pembrolizumab injection dosed at 200 mg given Q3 weeks by IV infusion on Day 1 of each 3 week cycle. Drug : Pembrolizumab Injection Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W. Other Names: Keytruda Primary Outcome Measures Outcome Measure Measure Description Time Frame Number of participants that develop an objective response to treatment. The objective response rate will be assessed by RECIST 1.1 Within 3 years Number of participants that develop an adverse event to treatment. Treatment related adverse events will be assessed using CTCAE v4.0. Within 3 years Secondary Outcome Measures Outcome Measure Measure Description Time Frame The overall survival (OS) of participants. OS is the time from treatment initiation to death due to any cause Within 4 years The progression free survival (PFS) of participants. Progression will be assessed by RECIST 1.1 Within 4 years The duration of response (DOR) of participants. Response will be assessed by RECIST 1.1 Within 4 years Keywords Provided by AHS Cancer Control Alberta CUP Pembrolizumab KEYTRUDA Additional Relevant MeSH Terms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasm Metastasis Neoplastic Processes Pathologic Processes Carcinoma Neoplasms, Unknown Primary Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Pembrolizumab Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Product Manufactured in and Exported from the U.S. Yes Revision: v2.9.1'SummaryDifference14%
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