Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)

Summary

The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.

Timeline

Start

2015-12-24

Primary completion

2019-09-13

Completion

2021-06-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Chemotherapy + Best Supportive Care (BSC) vs Avelumab; p = 0.1779 NCT02625610 ↗

paper JAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy PMID 33197226 ↗

Publications

• Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
• Moehler M, Dvorkin M, Boku N, Ozguroglu M, Ryu MH, Muntean AS, Lonardi S, Nechaeva M, Bragagnoli AC, Coskun HS, Cubillo Gracian A, Takano T, Wong R, Safran H, Vaccaro GM, Wainberg ZA, Silver MR, Xiong H, Hong J, Taieb J, Bang YJ. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100. J Clin Oncol. 2021 Mar 20;39(9):966-977. doi: 10.1200/JCO.20.00892. Epub 2020 Nov 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Capecitabine	Small molecule	1000 mg/m2	—
Subject	Leucovorin	Small molecule	200 mg/m2	Intravenous
Subject	Leucovorin	Small molecule	400 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	400 mg/m2	—
Subject	fluorouracil	Small molecule	2400 mg/m2	—
Subject	fluorouracil	Small molecule	2600 mg/m2	—

Indications