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RESEARCH PRODUCT

Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer: JAVELIN Gastric 100 study design.

Huiling XiongTaieb JulienMarkus MoehlerAkihito TsujiRachel WongRachel WongChia Jui YenZev A. WainbergMin Hee RyuSamuel Le SourdIlaria ContiManish PatelLindsay OvertonHyun Cheol ChungYung-jue BangArtem PoltoratskyNarikazu BokuMaitreyi SharmaHasan ŞEnol CoşkunKeun Wook LeeGina M. VaccaroMikhail DvorkinAlina Muntean

subject

0301 basic medicineOncologyCancer Researchmedicine.medical_specialtyBevacizumabmedicine.medical_treatmentAntineoplastic AgentsAntibodies Monoclonal HumanizedMaintenance ChemotherapyAvelumab03 medical and health sciences0302 clinical medicineMaintenance therapyStomach NeoplasmsInternal medicineBiomarkers TumorMedicineHumansMolecular Targeted TherapyNeoplasm StagingChemotherapybusiness.industryCancerAntibodies MonoclonalGeneral Medicinemedicine.diseaseOxaliplatin030104 developmental biologyTreatment OutcomeOncology030220 oncology & carcinogenesisMonoclonalAdenocarcinomabusinessmedicine.drug

description

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.

yearjournalcountryeditionlanguage
2018-11-01Future oncology (London, England)
10.2217/fon-2018-0668https://pubmed.ncbi.nlm.nih.gov/30379568