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Standard advanced treatment combines gemcitabine with cisplatin, yet immune-suppressed tumor microenvironments limit response to checkpoint inhibitor monotherapy. 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Median overall survival was 12.7 months with pembrolizumab plus gemcitabine/cisplatin versus 10.9 months with placebo plus gemcitabine/cisplatin, with a hazard ratio of 0.83.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},177586,1790254478,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":45},7971461740909,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Article Type: Fast-track Article - Randomised Controlled Trial\nTitle: Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled phase 3 trial\nAuthors: Prof Robin Kate Kelley, MD,1* Makoto Ueno, MD,2* Prof Changhoon Yoo, MD,3 Prof Richard S Finn, MD,4 Prof Junji Furuse, MD,5 Prof Zhenggang Ren, MD,6 Thomas Yau, MD,7 Heinz-Josef Klümpen, PhD,8 Prof Stephen L Chan, MD,9 Masato Ozaka, MD,10 Prof Chris Verslype, MD,11 Mohamed Bouattour, MD,12 Prof Joon Oh Park, MD,13 Olga Barajas, MD,14 Uwe Pelzer, MD,15 Prof Juan W Valle, MD,16 Li Yu, PhD,17 Usha Malhotra, MD,18 Abby B Siegel, MD,18 Prof Julien Edeline, PhD,19 Prof Arndt Vogel, MD20* on behalf of the KEYNOTE-966 Investigators†\nAffiliations: 1Department of Medicine (Hematology/Oncology), UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA; 2Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan; 3Department of Oncology, Asan Medical Center; University of Ulsan College of Medicine, Seoul, Republic of Korea; 4Department of Medicine, Division of Hematology/Oncology, Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 5Department of Medical Oncology, Kyorin University Hospital, Tokyo, Japan (currently affiliated with Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan); 6Department of Hepatic Oncology, Liver Cancer Institute of Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, Shanghai, China; 7Department of Medicine, University of Hong Kong, Hong Kong, China; 8Department of Medical Oncology, Amsterdam University Medical Centers, Cancer Center Amsterdam, Amsterdam, the Netherlands; 9State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Sir Yue-Kong Pao Center for Cancer, the Chinese University of Hong Kong, Hong Kong; 10Department of Hepato-Biliary-Pancreatic Medicine, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research (JFCR), Tokyo, Japan; 11Digestive Oncology, University Hospitals Leuven, Leuven, Belgium; 12Liver Cancer Unit, Hôpital Beaujon, Clichy, France; 13Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 14Department of Medical Oncology, Arturo López Pérez Foundation, Santiago, Chile; 15Department of Hematology, Oncology and Cancer Immunology, Charite Campus Mitte, Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health, Berlin, Germany; 16Division of Cancer Sciences, University of Manchester and Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom; 17Biostatistics and Research Decision Sciences, Merck & Co., Inc., Rahway, NJ, USA; 18Global Clinical Development, Merck & Co., Inc., Rahway, NJ, USA; 19INSERM, University Rennes, Department of Medical Oncology, CLCC Eugène Marquis, COSS (Chemistry Oncogenesis Signaling), Rennes, France; 20Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany\n*Drs. Kelley, Ueno, and Vogel contributed equally to this article.\n†The KEYNOTE-966 Investigators are listed in the appendix (pp 2-4).\nAddress for Correspondence\nProf Arndt Vogel, MD\nDepartment of Gastroenterology, Hepatology and Endocrinology\nHannover Medical School\nCarl-Neuberg-Str.1, 30625 Hannover, Germany\nEmail: vogel.arndt@mh-hannover.de\nTel: +49 511 532 9590\nSummary\nBackground: Biliary tract cancers, which arise from the intrahepatic or extrahepatic bile ducts and the gallbladder, generally have a poor prognosis and are rising in incidence worldwide. The standard-of-care treatment for advanced biliary tract cancer has been chemotherapy with gemcitabine and cisplatin. Because most biliary tract cancers have an immune-suppressed microenvironment, immune checkpoint","cbCaivqVFx7c2Qm1","https://ap.wps.com/l/cbCaivqVFx7c2Qm1","docx",555929,61,"English","# Background\n# Methods\n# Findings\n# Study design and endpoints","[{\"question\":\"What question did KEYNOTE-966 address?\",\"answer\":\"Whether adding pembrolizumab to gemcitabine and cisplatin improves outcomes compared with gemcitabine and cisplatin alone in advanced biliary tract cancer.\"},{\"question\":\"How were participants assigned and what treatment schedules were used?\",\"answer\":\"Participants were randomized 1:1 to pembrolizumab 200 mg or placebo every 3 weeks, each combined with gemcitabine on days 1 and 8 every 3 weeks and cisplatin on days 1 and 8 every 3 weeks.\"},{\"question\":\"What were the primary outcome and its main results?\",\"answer\":\"Overall survival was the primary endpoint. Median overall survival was 12.7 months with pembrolizumab plus gemcitabine/cisplatin versus 10.9 months with placebo plus gemcitabine/cisplatin, with a hazard ratio of 0.83.\"}]","Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for advanced biliary tract cancer (KEYNOTE-966) - a randomised, double-blind, placebo-controlled phase 3 trial | DOCX",1788328454]