Clinical trial NCT03006705: Study of Adjuvant ONO-4538 With Resected Gastric Cancer
Official title: A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2016-12-30
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed adenocarcinoma of the stomach
* Patients without a remnant cancer (R0) who have undergone gastrectomy
* Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Exclusion Criteria:

* Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer
* Multiple primary cancers
* A current or past history of severe hypersensitivity to any other antibody products
* Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease

Primary outcomes:
measure: Relapse-free survival (RFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: 3-year OS rate
timeFrame: 3 years
measure: 5-year OS rate
timeFrame: 5 years
measure: 3-year RFS rate
timeFrame: 3 years
measure: 5-year RFS rate
timeFrame: 5 years
measure: Safety will be analyzed through the incidence of adverse events, serious adverse events
timeFrame: Up to 28 days from last dose
measure: Safety will be analyzed through the incidence of laboratory abnormalities
timeFrame: Up to 28 days from last dose
Other outcomes:
Locations:
city: Anhui Province
country: China
facility: Anhui Province Clinical Site
city: Beijing
country: China
facility: Beijing Clinical Site1
city: Beijing
country: China
facility: Beijing Clinical Site2
city: Cuangdong Province
country: China
facility: Cuangdong Province Clinical Site
city: Guangdong Province
country: China
facility: Guangdong Province Clinical Site1
city: Guangdong Province
country: China
facility: Guangdong Province Clinical Site2
city: Henan Province
country: China
facility: Henan Province Clinical Site1
city: Henan Province
country: China
facility: Henan Province Clinical Site2
city: Jiangsu Province
country: China
facility: Jiangsu Province Clinical Site1
city: Jiangsu Province
country: China
facility: Jiangsu Province Clinical Site3
city: Jiangsu Province
country: China
facility: Jiangsu Province Clinical Site4
city: Jiangsu Province
country: China
facility: Jiangsu Province Clinical Site5
city: Jiangsu Province
country: China
facility: Jiangsu Province Clinical Site6
city: Jiangxi Province
country: China
facility: Jiangxi Province Clinical Site2
city: Jilin Province
country: China
facility: Jilin Province Clinical Site
city: Liaoning Province
country: China
facility: Liaoning Province Clinical Site
city: Shanxi Province
country: China
facility: Shanxi Province Clinical Site
city: Tianjin
country: China
facility: Tianjin Clinical Site1
city: Tianjin
country: China
facility: Tianjin Clinical Site2
city: Zhejiang Province
country: China
facility: Zhejiang Province Clinical Site
city: Zhengjiang Province
country: China
facility: Zhengjiang Province Clinical Site
city: Nagoya
country: Japan
facility: Aichi Clinical Site1
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Clinical Site2
state: Aichi
city: Kamogawa
country: Japan
facility: Chiba Clinical Site
state: Chiba
city: Matsuyama
country: Japan
facility: Ehime Clinical Site
state: Ehime
city: Matsuyama
country: Japan
facility: Ehime Clinicla Site
state: Ehime
city: Ōgaki
country: Japan
facility: Gifu Clinical Site
state: Gifu
city: Ota
country: Japan
facility: Gunma Clinical Site
state: Gunma
city: Takasaki
country: Japan
facility: Gunma Clinical Site
state: Gunma
city: Fukuyama
country: Japan
facility: Hiroshima Clinical Site
state: Hiroshima
city: Hakodate
country: Japan
facility: Hokkaido Clinical Site 3
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site 1
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site2
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Amagasaki
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Ishikawa Clinical Site
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Clinical Site
state: Iwate
city: Sagamihara
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Osaki
country: Japan
facility: Miyagi Clinical Site
state: Miyagi
city: Saku
country: Japan
facility: Nagano Clinical Site
state: Nagano
city: Kurashiki
country: Japan
facility: Okayama Clinical Site
state: Okayama
city: Hirakata
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Sakai
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Suita
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Toyonaka
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Ōsaka-sayama
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Clinical Site
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Saitama Clinical Site
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Clinical Site
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Tochigi Clinical Site
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Chiba
country: Japan
facility: Chiba Clinical Site
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site 1
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site 2
city: Gifu
country: Japan
facility: Gifu Clinical Site
city: Hiroshima
country: Japan
facility: Hiroshima Clinical Site1
city: Hiroshima
country: Japan
facility: Hiroshima Clinical Site2
city: Hiroshima
country: Japan
facility: Hiroshima Clinical Site3
city: Kochi
country: Japan
facility: Kochi Clinical Site
city: Kumamoto
country: Japan
facility: Kumamoto Clinical Site
city: Kyoto
country: Japan
facility: Kyoto Clinical Site
city: Niigata
country: Japan
facility: Niigata Clinical Site
city: Osaka
country: Japan
facility: Osaka Clinical Site1
city: Osaka
country: Japan
facility: Osaka Clinical Site2
city: Osaka
country: Japan
facility: Osaka Clinical Site3
city: Osaka
country: Japan
facility: Osaka Clinical Site4
city: Shizuoka
country: Japan
facility: Shizuoka Clinical Site
city: Toyama
country: Japan
facility: Toyama Clinical Site
city: Wakayama
country: Japan
facility: Wakayama Clinical Site
city: Yamagata
country: Japan
facility: Yamagata Clinical Site
city: Busan
country: Korea, Republic of
facility: Busan Clinical Site1
city: Busan
country: Korea, Republic of
facility: Busan Clinical Site2
city: Busan
country: Korea, Republic of
facility: Busan Clinical Site3
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site1
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site2
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site3
city: Daejeon
country: Korea, Republic of
facility: Daejeon Clinical Site 1
city: Daejeon
country: Korea, Republic of
facility: Daejeon Clinical Site 2
city: Gwangju
country: Korea, Republic of
facility: Gwangju Clinical Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi-do Clinical Site1
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi-do Clinical Site2
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi-do Clinical Site3
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi-do Clinical Site4
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi-do Clinical Site5
city: Jeollabuk-do
country: Korea, Republic of
facility: Jeollabuk-do Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 8
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 9
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site1
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site2
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site3
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site4
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site5
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site6
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site7
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site2
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site
city: New Taipei
country: Taiwan
facility: New Taipei Clinical Site
city: Taichung
country: Taiwan
facility: Taichung Clinical Site
city: Tainan
country: Taiwan
facility: Tainan Clinical Site2
city: Tainan
country: Taiwan
facility: Tainan Clinical Site
city: Taipei
country: Taiwan
facility: Taipei Clinical Site1
city: Taipei
country: Taiwan
facility: Taipei Clinical Site2
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References:
citation: 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.