Clinical trial NCT02267343: Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
Official title: ONO-4538 Phase III Study A Multicenter, Double-Blind, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 493
Sex: ALL
Minimum age (years): 20
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 ONO-4538 in patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) refractory to or intolerant of standard therapy.


Eligibility criteria: Inclusion Criteria:

* Men \& women ≥20 years of age
* Unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)
* Histologically confirmed adenocarcinoma
* Refractory to or intolerant of standard therapy
* ECOG Performance Status score 0 or 1
* A life expectancy of at least 3 months

Exclusion Criteria:

* Current or past history of severe hypersensitivity to any other antibody products
* Patients with multiple primary cancers
* Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
* Patients with active, known or suspected autoimmune disease

Primary outcomes:
measure: Overall survival
timeFrame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
measure: Objective response rate
timeFrame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
measure: Duration of response
timeFrame: Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
measure: Safety will be analyzed through the incidence of adverse events, serious adverse events
timeFrame: Continuously throughout study treatment and up to 28 days from last dose
measure: Safety will be analyzed through the incidence of laboratory abnormalities
timeFrame: Continuously throughout study treatment and up to 28 days from last dose
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Clinical Site
state: Aichi
city: Misawa
country: Japan
facility: Aomori Clinical Site
state: Aomori
city: Matsuyama
country: Japan
facility: Ehime Clinical Site
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Kobe
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Ishikawa Clinical Site
state: Ishikawa
city: Kawasaki
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Saku
country: Japan
facility: Nagano Clinical Site
state: Nagano
city: Osakasayama
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: Kitaadachi
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
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site
city: Gifu
country: Japan
facility: Gifu Clinical Site
city: Hiroshima
country: Japan
facility: Hiroshima Clinical Site
city: Osaka
country: Japan
facility: Osaka Clinical Site
city: Shizuoka
country: Japan
facility: Shizuoka Clinical Site
city: Busan-si
country: Korea, Republic of
facility: Busan-si Clinical Site
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site
city: Gyeonggi-Do
country: Korea, Republic of
facility: Gyeonggi-Do Clinical Site
city: Gyeonggi-Do
country: Korea, Republic of
facility: Gyeonggi-Do Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site
city: Taichung
country: Taiwan
facility: Taichung Clinical Site
city: Tainan
country: Taiwan
facility: Tainan Clinical Site
city: Taipei
country: Taiwan
facility: Taipei Clinical Site
city: Taipei
country: Taiwan
facility: Taipei Clinical Site
city: Taipei
country: Taiwan
facility: Taipei Clinical Site
city: Taipei
country: Taiwan
facility: Taipei Clinical Site
city: Taoyuan
country: Taiwan
facility: Taoyuan Clinical Site
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Mitsunobu Tanimoto
role: STUDY_DIRECTOR
References:
citation: Kang YK, Reck M, Nghiem P, Feng Y, Plautz G, Kim HR, Owonikoko TK, Boku N, Chen LT, Lei M, Chang H, Lin WH, Roy A, Bello A, Sheng J. Assessment of hyperprogression versus the natural course of disease development with nivolumab with or without ipilimumab versus placebo in phase III, randomized, controlled trials. J Immunother Cancer. 2022 Apr;10(4):e004273. doi: 10.1136/jitc-2021-004273.
citation: Kang YK, Boku N, Satoh T, Ryu MH, Chao Y, Kato K, Chung HC, Chen JS, Muro K, Kang WK, Yeh KH, Yoshikawa T, Oh SC, Bai LY, Tamura T, Lee KW, Hamamoto Y, Kim JG, Chin K, Oh DY, Minashi K, Cho JY, Tsuda M, Chen LT. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Dec 2;390(10111):2461-2471. doi: 10.1016/S0140-6736(17)31827-5. Epub 2017 Oct 6.