[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-382109-105":3,"detail-sidebar-cat-0-en-105":81,"doc-detail-382109-en":131},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","a-phase-ii-clinical-trial-of-nivolumab-and-temozolomide-for-neuroendocrine-neoplasms","A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms","","Treatment options remain limited for patients with metastatic neuroendocrine neoplasms (NEN). This nonrandomized phase II trial evaluates combination nivolumab plus temozolomide in advanced NEN and analyzes immune changes in peripheral blood. Response rate (RECIST 1.1) serves as the primary endpoint, with progression-free survival, overall survival, and safety as secondary endpoints. Exploratory mass cytometry characterizes immune cell subset dynamics.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/a-phase-ii-clinical-trial-of-nivolumab-and-temozolomide-for-neuroendocrine-neoplasms/382109/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/a-phase-ii-clinical-trial-of-nivolumab-and-temozolomide-for-neuroendocrine-neoplasms/382109.png","ImageObject",300,407,{"name":42,"@type":43},"acoobca","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-11-03","2026-09-24",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",11,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What is the purpose of this phase II trial?","Question",{"text":63,"@type":64},"The study evaluates combination nivolumab and temozolomide for advanced neuroendocrine neoplasms and examines immune changes in peripheral blood.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"How were responses and outcomes measured?",{"text":68,"@type":64},"The primary endpoint was response rate assessed by RECIST 1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.",{"name":70,"@type":61,"acceptedAnswer":71},"What immune changes were observed during treatment?",{"text":72,"@type":64},"After 2 weeks, circulating CD8+ T cells increased while CD4+ T cells decreased. Exploratory profiling also showed lower LAG-3–expressing T cells in patients experiencing a partial response.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},382109,1790808833,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,110,115,120,123,127],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":107,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":108,"slug":109},7,40,"healthcare",{"id":111,"doc_module":4,"doc_module_name":25,"category_name":112,"show_sort_weight":113,"slug":114},8,"Research & Report",30,"research-report",{"id":116,"doc_module":4,"doc_module_name":25,"category_name":117,"show_sort_weight":118,"slug":119},9,"Religion & Spirituality",20,"religion-spirituality",{"id":118,"doc_module":4,"doc_module_name":25,"category_name":121,"show_sort_weight":118,"slug":122},"World Cup","world-cup",{"id":124,"doc_module":4,"doc_module_name":25,"category_name":125,"show_sort_weight":124,"slug":126},10,"Lifestyle","lifestyle",{"id":128,"doc_module":4,"doc_module_name":25,"category_name":129,"show_sort_weight":97,"slug":130},19,"General","general",{"code":4,"msg":82,"data":132},{"doc_id":79,"user_id":133,"nickname":42,"user_avatar":134,"doc_module":4,"category_id":107,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":55,"language":140,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":12,"update_tm":144,"read_time":145},3985747870733,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms  \nDwight H. Owen1, Brooke Benner2, Lai Wei3, Vineeth Sukrithan1, Ashima Goyal1, Ye Zhou1, Carly Pilcher4, Sheryl-Ann Suffren4, Gwen Christenson4, Nancy Curtis4, Megan Jukich4, Emily Schwarz2,  \nHimanshu Savardekar2, Ruthann Norman2, Sarah Ferguson4, Barbara Kleiber4, Robert Wesolowski1, William E. Carson III2, Gregory A. Otterson1, Claire F. Verschraegen1, Manisha H. Shah1, and Bhavana Konda1  \n◥  \nPurpose: Treatment options are limited in patients with metastatic neuroendocrine neoplasms (NEN) . We present the results fora phase II trial of combination nivolumab and temozolomide inpatients with advanced NEN along with results of immune changes in peripheral blood.  \nPatients and Methods: NCT03728361is anonrandomized, phase II study of nivolumab and temozolomide in patients with NEN. The primary endpoint was response rate using RECIST 1.1 . Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Immune profilingwas performedbymass cytometry to evaluate the effect on peripheral blood immune cell subsets.  \nResults: Among all 28 patients with NEN, the confirmed response rate was 9/28 [32.1%, 95% confidence interval (CI): 15.9–52.4] . Of 11 patients with lung NEN, the response rate was  \n64%(n ¼ 7); there was a significant difference in responses by primary tumor location (lung vs. others, P ¼ 0.020) . The median PFS was8.8months(95%CI:3.9–11.1months), and median OS was 32.3 months (95% CI: 20.7—not reached months) . Exploratory blood immune cell profiling revealed an increase in circulating CD8þ T cells(27.9% 􀀂 13.4% vs. 31.7% 􀀂 14.6%, P ¼ 0.03)anda decrease in CD4þ T cells (59.6% 􀀂 13. 1% vs. 56.5% 􀀂 13.0%, P ¼ 0.001) after 2 weeks of treatment. LAG-3–expressing total T cells were lower inpatients experiencing a partial response (0.18% 􀀂 0.24% vs. 0.83% 􀀂 0.55%, P ¼ 0.028). Myeloid-derived suppressor cell levels increased during the study and did not correlate with response.  \nConclusions: Combination nivolumab and temozolomide demonstrated promising activity in NEN.  \nSee related commentary by Velez and Garon, p. 691  \nIntroduction  \nNeuroendocrine neoplasms (NEN) consist of a diverse group of tumors including low-grade gastroenteropancreatic neuroendocrine tumors (GEP-NET), thymic and lung NET as well as the aggressive, rapidly growing neuroendocrine carcinomas (NEC; ref. 1) . NEN can arise as primary tumors in almost any organ system of the body and Ki-67 index is often used to classify NETs into three grades per the World Health Organization (WHO) classification (2) . Current treatment options are limited and palliative in nature for patients with all types of metastatic NEN. Systemic therapy with somatostatin analogs (SSA) has been shown to provide control of carcinoid syndrome,  \n1Division of Medical Oncology, Department of Internal Medicine, The Ohio State University-James Comprehensive Cancer Center, Columbus, Ohio. 2Division of Surgical Oncology, Department of Surgery, The Ohio State University-James Comprehensive Cancer Center, Columbus, Ohio. 3Department of Biomedical Informatics and Center for Biostatistics, The Ohio State University - James Comprehensive Cancer Center, Columbus, Ohio. 4Clinical Trials Office, The Ohio State University-James Comprehensive Cancer Center, Columbus, Ohio.  \nD. H. Owen and B. Benner contributed as co-first authors and M. H. Shah and  \nB. Konda as co-senior authors of this article.  \nCorresponding Author: Dwight H. Owen, The Ohio State University -James Comprehensive Cancer Center, 1800 Cannon Drive, Columbus, OH 43201 .  \nPhone: 614-685-2039; E-mail: [Dwight.Owen@osumc.edu](Dwight.Owen@osumc.edu)[ ](Dwight.Owen@osumc.edu)[Clin Cancer Res 2023](Clin Cancer Res 2023);[29:731](29:731)–[41](41)  \n[doi:](doi: 10.1158/1078-0432.CCR-22-1552)[ 10.1158/1078-0432.CCR-22-1552](doi: 10.1158/1078-0432.CCR-22-1552)  \nThis open access article is distributed under the Creative Commons A","cbCaikAucj3Bgv9h","https://ap.wps.com/l/cbCaikAucj3Bgv9h","pdf",6151034,"English","## Purpose\n## Patients and Methods\n## Results\n## Conclusions\n## Introduction","[{\"question\":\"What is the purpose of this phase II trial?\",\"answer\":\"The study evaluates combination nivolumab and temozolomide for advanced neuroendocrine neoplasms and examines immune changes in peripheral blood.\"},{\"question\":\"How were responses and outcomes measured?\",\"answer\":\"The primary endpoint was response rate assessed by RECIST 1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.\"},{\"question\":\"What immune changes were observed during treatment?\",\"answer\":\"After 2 weeks, circulating CD8+ T cells increased while CD4+ T cells decreased. Exploratory profiling also showed lower LAG-3–expressing T cells in patients experiencing a partial response.\"}]","A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms | PDF",1790249113,28]