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    32 days ago
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    Summary
    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Lung cancer MedlinePlus related topics: Lung Cancer Genetic and Rare Diseases Information Center resources: Transitional Cell Carcinoma Drug Information available for: Atezolizumab 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 : atezolizumab (MPDL3280A) + epacadostat (INCB024360) atezolizumab (MPDL3280A) 1200 mg given every 3 weeks + epacadostat (INCB024360) 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified Drug : atezolizumab atezolizumab: administered intravenously (IV) every three weeks (q3w) Other Names: MPDL3280A Drug : epacadostat epacadostat: Oral daily dosing Other Names: INCB024360 Primary Outcome Measures Outcome Measure Measure Description Time Frame Incidence of adverse events (AEs) Continuously for duration of study participation and up to 42 days after the last dose [approximately 8 months Incidence of dose-limiting toxicities (DLTs) 21 days following the first administration of atezolizumab and epacadostat Secondary Outcome Measures Outcome Measure Measure Description Time Frame Objective response rate (ORR) ORR determined by radiographic disease assessments per modified RECIST v1.1 Measured every 6 weeks for duration of study participation [approximately 8 months] Durability of response Time from the earliest date of disease response until earliest date of disease progression based on modified RECIST v1.1 Measured every 6 weeks for duration of study participation [approximately 8 months] Progression-free survival Time from date of enrollment until the earliest date of disease progression per modified RECIST v1.1 or death due to any cause, whichever is earlier. Measured every 6 weeks for duration of study participation [approximately 8 months] Duration of disease control Time from first dose until report of disease progression for subjects who reported stable disease or better based on modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Additional Relevant MeSH Terms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Transitional Cell Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Antineoplastic Agents Atezolizumab Revision: v2.9.1.'
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