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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: Nasopharyngeal Carcinoma 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 Total 51 weeks for 17 doses of pembrolizumab: Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab) Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab) Drug : Pembrolizumab 200mg every 3 weeks infusion Other Names: Concurrent Chemoradiation Primary Outcome Measures Outcome Measure Measure Description Time Frame Two-year progression free survival 2 years Secondary Outcome Measures Outcome Measure Measure Description Time Frame Grade 4 mucositis/skin reaction or any Grade 5 adverse event assessed to be definitely, probably, or possibly related to protocol treatment during the first year use toxicity chart to capture during the first year Grade 4 mucositis/skin reaction or any Grade 5 adverse event assessed to be definitely, probably, or possibly related to protocol treatment occurring after the first year after the first year Patient tolerability to each component (neoadjuvant, concurrent and maintenance part) of the protocol treatment regimen 2 year Other ≥ Grade 3 adverse events 2 year Death during or within 30 days of discontinuation of protocol treatment during or within 30 days One- and two-year distant metastases rates 1 year and 2 years One- and two-year local-regional progression rates 1 year and 2 years One- and two-year rates of second primary cancer 1 year and 2 years One- and two-year overall survival rates 1 year and 2 years Additional Relevant MeSH Terms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Nasopharyngeal Neoplasms Nasopharyngeal 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 No Studies a U.S. FDA-Regulated Device Product No Revision: v2.9.1'
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    Check dated 2024-06-25T08:21:38.000Z thumbnail image

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