Phase 2 trial of bintrafusp alfa as second-line therapy for patients with locally advanced/metastatic biliary tract cancers.

"CONFLICTS OF INTEREST Changhoon Yoo consults, advises, and received grants from Servier, Bayer, AstraZeneca, Celgene, Ipsen, and Boryung Pharmaceuticals. He consults and advises Merck and Co., Kenilworth, NJ, Eisai, Bristol Myers Squibb, Debiopharm, Kyowa Kirin, Novartis, the healthcare business of Merck KGaA, Darmstadt, Germany, Mundipharma, Roche, and Janssen. He received grants from Ono Pharmaceuticals, Ildong Pharmaceuticals, CKD Pharmaceuticals, and HK inno.N. Milind M. Javle advises and received grants from Incyte, Merck and Co., Kenilworth, NJ, QED, and the healthcare business of Merck, KGaA, Darmstadt, Germany. He advises Mundipharma, and OncoSil. He received grants from Bayer, Beigene, Novartis, Pieris, Rafael and Seattle Genetics. Helena Verdaguer Mata advises the healthcare business of Merck, KGaA, Darmstadt, Germany. She is on the speakers’ bureau for AstraZeneca. Filippo de Braud advises, is on the speakers’ board, received grants and compensation from Bristol Myers Squibb and Roche. He advises, is on the speakers’ board, and received grants from Merck and Co., Kenilworth, NJ, and Pfizer. He advises and is on the speakers’ board for Bayer, Dephaforum, and Ignyta. He advises and received grants and compensation from Celgene. He advises and received grants from Incyte and Novartis. He advises and received compensation from Amgen. He advises AstraZeneca, Daiichi Sankyo, Gentili, Eli Lilly, Fondazione Menarini, Octimet Oncology, Pharm Research Associated, Pierre Fabre, Servier, and Tiziana Life Sciences. He is on the speakers’ bureau for Biotechespert and Prime Oncology. He received grants from Kymab, the healthcare business of Merck KGaA, Darmstadt, Germany, NMS, and Tesaro. Jörg Trojan advises and or consults for Amgen, AstraZeneca, Bayer Healthcare, Bristol Myers Squibb, Eisai, Institute for Quality and Efficiency in Health Care (IQWiG), Ipsen, the healthcare business of Merck KGaA, Darmstadt, Germany, Merck and Co., Kenilworth, NJ, Lilly Imclone, PCI Biotech, onkowissen.de, Roche, Servier, and Streamedup. Jean-Luc Raoul consults for and is on the speakers’ bureau for Bayer HealthCare Pharmaceuticals. He consults for Biocompatibles. He is on the speakers’ bureau for Servier. Jin Won Kim consults for Roche, AstraZeneca, Beyond Bio, Eisai, Merck and Co., Kenilworth, NJ, Beigene, Bristol Myers Squibb, GC Cell, Ono Pharmaceutical, Sanofi-Aventis, Servier, TCUBEit. He received grants from HK inno.N and Jeil Pharmaceutical. Makoto Ueno reports honoraria from Taiho Pharmaceutical, Yakult Honsha, AstraZeneca, Ono Pharmaceutical, the healthcare business of Merck KGaA, Darmstadt, Germany, and Merck and Co., Kenilworth, NJ. He received grants from Taiho Pharmaceutical, Daiichi Sankyo, Eisai, AstraZeneca, Ono Pharmaceutical, Merck and Co., Kenilworth, NJ, the healthcare business of Merck KGaA, Darmstadt, Germany, Dainippon Sumitomo Pharma, Incyte, Yakult Honsha, and Astellas. Choong-kun Lee advises and consults for AstraZeneca. Susumu Hijioka reports honoraria from Taiho Pharmaceutical, AstraZeneca, Novartis, and Teijin Pharma. He received grants from Daiichi Sankyo and Astellas. Junji Furuse reports honoraria from Eisai, Bayer Yakuhin, Taiho Pharmaceutical, Ono Pharmaceutical, Novartis, Yakult Honsha, Teijin Pharma, Shionogi, EA Pharma, Eli Lilly Japan, Takeda, Chugai Pharma, Mochida Pharmaceutical, Nihon Servier, Sanofi, Fujifilm Toyama Chemical, Nobel Pharma, Pfizer, Sawai Pharmaceutical, Daiichi Sankyo, Sumitomo Dainippon, the healthcare business of Merck KGaA, Darmstadt, Germany, Nippon Kayaku, Merck and Co., Kenilworth, NJ, Shire, and Kyowa Hakko Kirin. He received grants from Ono Pharmaceutical, Merck and Co., Kenilworth, NJ, Sumitomo Dainippon, J-Pharma, Yakult Honsha, AstraZeneca, Daiichi Sankyo, Eisai, Bayer, Pfizer, NanoCarrier, Kyowa Hakko Kirin, Taiho Pharmaceutical, Chugai Pharma, Sanofi, Takeda, Mochida Pharmaceutical, Astellas Pharma, and Eli Lilly Japan. Masashi Sato is employed by Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Darmstadt, Germany. Yulia Vugmeyster is employed by and owns intellectual property rights in EMD, Billerica, MA, USA. Andreas Machl is employed by EMD Serono, Billerica, MA, USA. Marcis Bajars is employed by and owns stock in the healthcare business of Merck KGaA, Darmstadt, Germany. John Bridgewater consults, advises, and is on the speakers’ bureau for Bristol Myers Squibb. He consults, advises, and received grants from Incyte. He consults and advises the healthcare business of Merck KGaA, Darmstadt, Germany, and Roche. He advises Taiho and the healthcare business of Merck KGaA, Darmstadt, Germany. He is on the speakers’ bureau for Servier. He received grants from Merck and Co., Kenilworth, NJ. Do-Youn Oh consults for, advises, and received grants from AstraZeneca, Novartis, BeiGene, and Merck and Co., Kenilworth, NJ. She consults for and advises Genentech/Roche, the healthcare business of Merck KGaA, Darmstadt, Germany, Taiho, ASLAN, Halozyme, Zymeworks, BMS/Celgene, Basilea, Turning Point, Yuhan, Arcus Biosciences, and IQVIA. She received grants from Array, Eli Lilly, Servier, and Handok. Mitesh J. Borad advises and consults for ADC Therapeutics, Exelixis, Inspyr Therapeutics, G1 Therapeutics, Immunovative Therapies, OncBioMune, Western Oncolytics, Lynx Group, Genentech, Merck and Co., Kenilworth, NJ, and Huya. He received grants from Senhwa Pharmaceuticals, Adaptimmune, Agios, Halozyme, Celgene Pharmaceuticals, the healthcare business of Merck KGaA, Darmstadt, Germany, Toray, Dicerna, Taiho, Sun Biopharma, Isis Pharmaceuticals, Redhill Pharmaceuticals, Boston Biomed, Basilea, Incyte, and Mirna Pharmaceuticals. The remaining authors have no conflicts to report."

"FUNDING INFORMATION The trial was sponsored by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945) and was previously part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline."