Clinical Trial Protocol

REVIVE study: a prospective observational study in chemotherapy after nivolumab therapy for advanced gastric cancer

Yukiya Narita

https://orcid.org/0000-0002-8018-0077

Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, 464-8681, Japan

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Hirokazu Shoji

Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, 104-0045, Japan

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Sadayuki Kawai

Department of Medical Oncology, Shizuoka General Hospital, Shizuoka, 420-5827, Japan

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Takuro Mizukami

https://orcid.org/0000-0002-9960-5629

Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, 216-8511, Japan

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Michio Nakamura

https://orcid.org/0000-0002-1509-9811

Department of Gastroenterology, Sapporo City General Hospital, Sapporo, 060-8604, Japan

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Toshikazu Moriwaki

Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8577, Japan

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Takeharu Yamanaka

Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, 236-0004, Japan

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Yu Sunakawa

https://orcid.org/0000-0002-0163-7543

Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, 216-8511, Japan

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Hisato Kawakami

Department of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama, 577-8502, Japan

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Tomohiro Nishina

Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, 791-0280, Japan

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Toshihiro Misumi

Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, 236-0004, Japan

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Kei Muro

*Author for correspondence: Tel.: +815 276 2611; Fax: +815 2764 9855;

E-mail Address: kmuro@aichi-cc.jp

Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, 464-8681, Japan

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Published Online:21 Sep 2020https://doi.org/10.2217/fon-2020-0621

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Abstract

Nivolumab is an increasingly used standard care treatment for heavily pretreated patients with advanced gastric cancer, with increasing clinical use in Japan. Data from retrospective studies on various tumors have shown the objective response rate to cytotoxic chemotherapy potentially improves after an exposure to immune checkpoint inhibitors. Based on these data, we conducted the multicenter observational REVIVE study to evaluate the efficacy and safety of cytotoxic chemotherapy in nivolumab-refractory or nivolumab-intolerant patients with advanced gastric cancer. Patients who are refractory or intolerant to nivolumab and scheduled to receive irinotecan monotherapy, oxaliplatin combination treatment or oral trifluridine/tipiracil hydrochloride therapy will be included. The primary end point is overall survival of nivolumab-pretreated patients with advanced gastric cancer after the cytotoxic chemotherapy.

Clinical trial registration: UMIN000032182 ( umin.ac.jp)

Lay abstract

Nivolumab is an increasingly used standard care treatment for heavily-pretreated patients with advanced gastric cancer, with increasing clinical use in Japan. Data from retrospective studies on various tumors have shown the objective response rate to cytotoxic chemotherapy potentially improves after an exposure to immune checkpoint inhibitors. Based on these data, we conducted the multicenter observational REVIVE study to evaluate the efficacy and safety of cytotoxic chemotherapy in nivolumab-refractory or nivolumab-intolerant patients with advanced gastric cancer.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 17, No. 8
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History

Received 15 June 2020

Accepted 18 August 2020

Published online 21 September 2020

Published in print March 2021

Information
© 2021 Future Medicine Ltd
Keywords
Author contributions
Y Narita generated and edited the figures and wrote the manuscript. The manuscript was reviewed by H Shoji, S Kawai, T Mizukami, M Nakamura, T Moriwaki, T Yamanaka, Y Sunakawa, H Kawakami, T Nishina, T Misumi and K Muro. All authors read and approved the final version of the manuscript.
Financial & competing interests disclosure
This study is provided to Public Health Research Foundation with support from Ono Pharmaceutical Co., Ltd and Bristol-Myers Squibb Bristol-Myers Squibb Company. Y Narita reports grants and personal fees from Ono Pharmaceutical Co., Ltd and Bristol-Myers Squibb, personal fees from Eli Lilly, Yakult Honsha, Daiichi Sankyo and Taiho, outside the submitted work; H Shoji reports research fund from Ono pharmaceutical Co., Ltd, MSD and Astellas, outside the submitted work; T Mizukami reports grants and personal fees from Taiho Pharmaceutical, Eli Lilly Japan, grants from Ono Pharmaceutical, personal fees from Sanofi, Asahi Kasei Pharmaceutical, and Takeda pharmaceutical, outside the submitted work; T Moriwaki reports grants and personal fees from Takeda Pharmaceutical, Chugai Pharma, Taiho Pharmaceutical and Yakult Honsha, personal fees from Sanofi, Eli Lilly Japan and Ono pharmaceutical Co., Ltd, grants from MSD Oncology, outside the submitted work; T Yamanaka reports grants and personal fees from Takeda, Chugai, Boehringer Ingelheim, Taiho, Daiichi-Sankyo and Bayer, grants from Ono, Merck Serono, Astellas and Eli Lilly, personal fees from Pfizer, Sysmex, Huya Biosciences and Gilead Sciences, outside the submitted work; Y Sunakawa reports personal fees from Bristol-Myers Squibb Japan during the conduct of the study; personal fees from Chugai Pharma, Taiho Pharmaceutical, Lilly Japan, Sanofi, Bristol-Myers Squibb Japan, Yakult Honsha, Bayer Yakuhin, Kyowa Kirin, Nippon Kayaku and Daiichi Sankyo, outside the submitted work; H Kawakami reports grants from Daiichi Sankyo, personal fees from Eli Lilly, Ono pharmaceutical, Co., Ltd, Chugai pharmaceutical Co., Ltd, Taiho pharmaceutical Co., Ltd, MSD pharmaceutical, Co., Ltd, Merck Serono, Takeda pharmaceutical, Co., Ltd, Astra Zeneca KK and Yakult pharmaceutical industry, Co., Ltd, outside the submitted work; T Nishina reports grants and personal fees from Taiho pharma, Chugai pharma, Ono pharmaceutical Co., Ltd, Bristol-Myers Squibb and Lilly, grants from Daiichi Sankyo, MSD and Dainippon sumitomo pharma, outside the submitted work; and K Muro reports grants and personal fees from Ono pharmaceutical Co., Ltd and Sanofi, grants from Daiichi Sankyo, Parexel International, Shionogi Pharma, Sumitomo Dainippon, MSD, Pfizer, Mediscience Planning and Solasia Pharma, personal fees from Eli Lilly, Chugai, Takeda, Taiho, Bristol-Myers Squibb and Bayer, outside the submitted work. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
The authors thank Enago (www.enago.jp) for English language editing and all the patients who participated in this study and their families.

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REVIVE study: a prospective observational study in chemotherapy after nivolumab therapy for advanced gastric cancer

Abstract

Lay abstract

References