Phase 1 trial of avelumab (anti-PD-L1) in Japanese patients with advanced solid tumors, including dose expansion in patients with gastric or gastroesophageal junction cancer: the JAVELIN Solid Tumor JPN trial.

"Conflict of interest TD has received research funding from AbbVie, Astellas Pharma, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai Pharma, Daiichi Sankyo, IQVIA, Janssen, Kyowa Hakko Kirin, Lilly Japan, MSD, Merck Serono, Novartis, Pfizer, Sumitomo Group Takeda, and Taiho Pharmaceutical, and reports consulting roles for Amgen, Chugai Pharma, Daiichi Sankyo, Kyowa Hakko Kirin, Lilly Japan, MSD, Sumitomo Dainippon, and Taiho Pharmaceutical. SI reports honoraria from Chugai Pharma and Takeda, and has received research funding from AbbVie, AstraZeneca, Astellas, Bayer, Chugai Pharma, Daiichi Sankyo, Eisai, Lilly, Merck Serono, Nano Carrier, Novartis, Ono Pharmaceutical, Otsuka, Sanofi, Sumitomo Dainippon, Taiho Pharmaceutical, and Teijin. KM reports honoraria from Chugai Pharma, Merck Serono, Takeda, Taiho Pharmaceutical, and Yakult. TS reports honoraria and consulting or advisory roles for Bristol-Myers Squibb, Chugai Pharma, and Merck Serono; TS also reports consulting or advisory roles for Lilly and has received research funding from Chugai Pharma and Yakult. SH reports honoraria from Novartis, Taiho Pharmaceutical, Takeda, and Yakult, and reports consulting or advisory roles for Lilly and Yakult. TE has received research funding from Merck Serono. TN reports honoraria from Merck Serono. HH reports honoraria from Chugai Pharma, Lilly, Merck Serono, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, and Yakult, and reports consulting or advisory roles from Chugai Pharma, MSD, Merck Serono, and Ono Pharmaceutical. HH has received research funding from AstraZeneca, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Eisai, Incyte, Lilly, LSK BioPharma, MSD, Merck Serono, Ono Pharmaceutical, Pfizer, Sumitomo Dainippon, Taiho Pharmaceutical, and Takeda. NM and SO have no disclosures to report. YK reports honoraria and speaker services for Bayer, Novartis, and Pfizer; YK also reports speaker services for Chugai Pharma, Lilly, Merck Serono, and Taiho Pharmaceutical, and research funding from Bayer, Chugai Pharma, Lilly, MSD, Novartis, Ono Pharmaceutical, Taiho, and Yakult. YS reports honoraria from Bayer Yakuhin, Chugai Pharma, Daiichi Sankyo, Lilly, Merck Serono, Novartis, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, and Yakult; YS has also received research funding from Chugai Pharma, Lilly, Merck Serono, MSD, and Taiho Pharmaceutical. SS and MW are employees of Merck Serono."

"We thank the patients and their families, the investigators, the coinvestigators, and the study teams at each of the participating centers and at Merck KGaA, Darmstadt, Germany and Merck Serono, Tokyo, Japan (a Japanese subsidiary of Merck KGaA, Darmstadt, Germany). We also thank Vikram Chand (formerly of EMD Serono) for his medical guidance during the conduct of the trial. This trial was sponsored by Merck KGaA and is part of an alliance between Merck KGaA and Pfizer (New York, NY, USA). Medical writing support was provided by ClinicalThinking and funded by Merck KGaA and Pfizer."