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The study has been updated to version v2.10.0, replacing 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 recently changed to 'Show less MedlinePlus Genetics related topics: Head and neck squamous cell carcinoma Drug Information available for: Nivolumab 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 : Nivolumab+Lirilumab The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Drug : Nivolumab Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Drug : Lirilumab Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Primary Outcome Measures Outcome Measure Measure Description Time Frame 1-Year Disease-Free Survival Percentage The percentage of patients who were alive and disease free at one year past salvage surgery. Patients who were alive at last contact prior to the one year mark are censored. Data analysis conducted through Kaplan Meier methods. 1 year since salvage surgery, up to 1 year and 23 days since treatment start Secondary Outcome Measures Outcome Measure Measure Description Time Frame Response at Time of Salvage Surgery Response is classified using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Complete Response - Disappearance of all lesions and pathologic lymph nodes. Partial Response - At least 30% decrease in sum of longest diameters (SLD) for the target lesions, no new lesions, and no progression of non-target lesions. Progressive Disease - At least 20% increase in SLD compared to smallest SLD in study or progression of non-target lesions or development of new lesions Stable Disease - No Partial Response and no Progressive Disease. At the time of salvage surgery, up to 23 days from treatment start date. Median Disease-Free Survival Rate The median time that patients were alive and disease free after salvage surgery. Patients who were alive at last contact are censored at last contact. Data analysis conducted through Kaplan Meier methods Up to 27.2 months post salvage surgery, up to 28 months total. 1-Year Overall Survival Percentage Percentage of participants who were alive at 1 year since salvage surgery. Patients alive at last contact prior to 1 year were censored. 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score The median change in Programmed Cell Death Ligand - 1 Combined Positive Score (PD-L1 CPS) from baseline to surgery. The score is derived from tumor tissue samples that measures the presence of both tumor and immune cell staining for the PD-L1 marker. Scored from 0-100, a higher score suggests the patient might respond better to treatment. A pathological responder is defined as having less than 50% viable tumor at the time of surgery. Measured at baseline and then at time of salvage surgery, up to 23 days. Keywords Provided by Glenn J. Hanna, Dana-Farber Cancer Institute Squamous Cell Carcinoma Additional Relevant MeSH Terms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Nivolumab 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 Glenn J. Hanna, Dana-Farber Cancer Institute Study Protocol and Statistical Analysis Plan [ PDF , 1.08MB, 2019-08-16 ] Revision: v2.9.1'
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