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; Julien Taieb; Yung Jue Bang

doi:10.2217/fon-2018-0668

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 ContiJulien Taieb, Yung Jue Bang

Knight Cancer Institute

Research output: Contribution to journal › Article › peer-review

21 Scopus citations

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 language	English (US)
Pages (from-to)	567-577
Number of pages	11
Journal	Future Oncology
Volume	15
Issue number	6
DOIs	https://doi.org/10.2217/fon-2018-0668
State	Published - Feb 2019

Keywords

PD-L1
avelumab
gastric cancer

ASJC Scopus subject areas

Oncology
Cancer Research

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10.2217/fon-2018-0668

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Moehler, M., Ryu, M. H., Dvorkin, M., Lee, K. W., Coşkun, H., Wong, R., Chung, H. C., Poltoratsky, A., Tsuji, A., Yen, C. J., Muntean, A. S., Le Sourd, S., Vaccaro, G. M., Overton, L., Boku, N., Wainberg, Z. A., Patel, M., Sharma, M., Xiong, H., ... 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, M, Ryu, MH, Dvorkin, M, Lee, KW, Coşkun, H, Wong, R, Chung, HC, Poltoratsky, A, Tsuji, A, Yen, CJ, 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

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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.",

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AU - Lee, Keun Wook

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AU - Chung, Hyun C.

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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

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

Abstract

Keywords

ASJC Scopus subject areas

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