| Literature DB >> 30379568 |
Markus Moehler1, Min-Hee Ryu2, Mikhail Dvorkin3, Keun-Wook Lee4, Hasan Ş Coşkun5, Rachel Wong6,7, Hyun C Chung8, Artem Poltoratsky9, Akihito Tsuji10, Chia Jui Yen11, Alina S Muntean12, Samuel Le Sourd13, Gina M Vaccaro14, Lindsay Overton15, Narikazu Boku16, Zev A Wainberg17, Manish Patel18, Maitreyi Sharma19, Huiling Xiong19, Ilaria Conti19, Julien Taieb20, Yung-Jue Bang21.
Abstract
Avelumab is a human anti-PD-L1 IgG1 monoclonal antibody that has shown antitumor activity in early phase studies in advanced/metastatic gastric/gastroesophageal junction cancer, including as first-line maintenance therapy. Here, we describe the design of JAVELIN Gastric 100 (NCT02625610), an open-label, Phase III trial. A total of 499 patients with locally advanced/metastatic HER2- gastric/gastroesophageal junction cancer adenocarcinoma, who had achieved at least stable disease following 12 weeks of first-line oxaliplatin/fluoropyrimidine chemotherapy, have been randomized 1:1 to receive avelumab maintenance therapy or continue chemotherapy. The primary objective is to demonstrate superior overall survival in all randomized patients or in the PD-L1+ population. Secondary objectives are to demonstrate superiority for progression-free survival and objective response rate, compare quality of life measures, and determine safety.Entities:
Keywords: PD-L1; avelumab; gastric cancer
Mesh：
Substances：
Year: 2018 PMID： 30379568 DOI： 10.2217/fon-2018-0668
Source DB: PubMed Journal: Future Oncol ISSN： 1479-6694 Impact factor: 3.404