drugset / Trial / NCT02625610
Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)
Phase 3
Completed
499 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
RandomizedSequentialOpen-labelTreatment
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
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 | — |