Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer

JAVELIN Gastric 100 study design

Markus Moehler, Min Hee Ryu, Mikhail Dvorkin, Keun Wook Lee, Hasan Coşkun, Rachel Wong, Hyun C. Chung, Artem Poltoratsky, Akihito Tsuji, Chia-Jui Yen, Alina S. Muntean, Samuel Le Sourd, Gina M. Vaccaro, Lindsay Overton, Narikazu Boku, Zev A. Wainberg, Manish Patel, Maitreyi Sharma, Huiling Xiong, Ilaria Conti & 2 others Julien Taieb, Yung Jue Bang

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)567-577
Number of pages11
JournalFuture Oncology
Volume15
Issue number6
DOIs
Publication statusPublished - 2019 Feb 1

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Stomach Neoplasms
Esophagogastric Junction
Stomach
oxaliplatin
Maintenance
Drug Therapy
Disease-Free Survival
Neoplasms
Adenocarcinoma
Immunoglobulin G
Monoclonal Antibodies
Quality of Life
Safety
Survival
Therapeutics
Population
avelumab

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Moehler, M., Ryu, M. H., Dvorkin, M., Lee, K. W., Coşkun, H., Wong, R., ... Bang, Y. J. (2019). Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer: JAVELIN Gastric 100 study design. Future Oncology, 15(6), 567-577. https://doi.org/10.2217/fon-2018-0668
Moehler, Markus ; Ryu, Min Hee ; Dvorkin, Mikhail ; Lee, Keun Wook ; Coşkun, Hasan ; Wong, Rachel ; Chung, Hyun C. ; Poltoratsky, Artem ; Tsuji, Akihito ; Yen, Chia-Jui ; Muntean, Alina S. ; Le Sourd, Samuel ; Vaccaro, Gina M. ; Overton, Lindsay ; Boku, Narikazu ; Wainberg, Zev A. ; Patel, Manish ; Sharma, Maitreyi ; Xiong, Huiling ; Conti, Ilaria ; Taieb, Julien ; Bang, Yung Jue. / Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer : JAVELIN Gastric 100 study design. In: Future Oncology. 2019 ; Vol. 15, No. 6. pp. 567-577.
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Moehler, M, Ryu, MH, Dvorkin, M, Lee, KW, Coşkun, H, Wong, R, Chung, HC, Poltoratsky, A, Tsuji, A, Yen, C-J, Muntean, AS, Le Sourd, S, Vaccaro, GM, Overton, L, Boku, N, Wainberg, ZA, Patel, M, Sharma, M, Xiong, H, Conti, I, Taieb, J & Bang, YJ 2019, 'Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer: JAVELIN Gastric 100 study design', Future Oncology, vol. 15, no. 6, pp. 567-577. https://doi.org/10.2217/fon-2018-0668

Maintenance avelumab versus continuation of first-line chemotherapy in gastric cancer : JAVELIN Gastric 100 study design. / Moehler, Markus; Ryu, Min Hee; Dvorkin, Mikhail; Lee, Keun Wook; Coşkun, Hasan; Wong, Rachel; Chung, Hyun C.; Poltoratsky, Artem; Tsuji, Akihito; Yen, Chia-Jui; Muntean, Alina S.; Le Sourd, Samuel; Vaccaro, Gina M.; Overton, Lindsay; Boku, Narikazu; Wainberg, Zev A.; Patel, Manish; Sharma, Maitreyi; Xiong, Huiling; Conti, Ilaria; Taieb, Julien; Bang, Yung Jue.

In: Future Oncology, Vol. 15, No. 6, 01.02.2019, p. 567-577.

Research output: Contribution to journalArticle

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T2 - JAVELIN Gastric 100 study design

AU - Moehler, Markus

AU - Ryu, Min Hee

AU - Dvorkin, Mikhail

AU - Lee, Keun Wook

AU - Coşkun, Hasan

AU - Wong, Rachel

AU - Chung, Hyun C.

AU - Poltoratsky, Artem

AU - Tsuji, Akihito

AU - Yen, Chia-Jui

AU - Muntean, Alina S.

AU - Le Sourd, Samuel

AU - Vaccaro, Gina M.

AU - Overton, Lindsay

AU - Boku, Narikazu

AU - Wainberg, Zev A.

AU - Patel, Manish

AU - Sharma, Maitreyi

AU - Xiong, Huiling

AU - Conti, Ilaria

AU - Taieb, Julien

AU - Bang, Yung Jue

PY - 2019/2/1

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N2 - 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.

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