Clinical trial NCT02746796: Study of ONO-4538 in Gastric Cancer
Official title: ONO-4538 Phase II/III Study A Multicenter, Randomized Study in Patients With Unresectable Advanced or Recurrent Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 680
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 with chemotherapy in unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) not previously treated with the first-line therapy. Part 1 is intended to evaluate the tolerability, safety, and efficacy of ONO-4538 in combination with SOX therapy (Tegafur / gimeracil / oteracil potassium + Oxaliplatin) or CapeOX therapy (Capecitabine + Oxaliplatin). In part 2, the investigator or the subinvestigator will choose a chemotherapy (SOX or CapeOX therapy), taking into account the condition of each subject. Part 2 is planned to evaluate the efficacy and safety of ONO-4538 + chemotherapy in comparison with placebo + chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has not been treated with the first-line therapy with systemic antitumor agents for advanced or recurrent gastric cancer (including esophagogastric junction cancer)
* Have measurable lesions as defined in RECIST Guideline Version 1.1
* ECOG PS score 0 or 1
* Have a life expectancy of at least 3 months

Exclusion Criteria:

* Have multiple cancers
* Have a current or past history of severe hypersensitivity to any other antibody products
* 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: Progression-free survival (central assessment by IRRC) (only Part 2)
timeFrame: Up to study completion (estimated time frame: 48 months)
measure: Overall survival (only Part 2)
timeFrame: Up to study completion (estimated time frame: 54 months)
Secondary outcomes:
measure: Objective response rate (only Part 2)
timeFrame: Up to study completion (estimated time frame: 54 months)
measure: Progression-free survival (assessment by the site investigator)(only Part 2)
timeFrame: Up to study completion (estimated time frame: 54 months)
measure: Duration of response (only Part 2)
timeFrame: Up to study completion (estimated time frame: 54 months)
measure: Disease control rate (only Part 2)
timeFrame: Up to study completion (estimated time frame: 54 months)
measure: Time to response (only Part 2)
timeFrame: Up to study completion (estimated time frame: 54 months)
measure: Best overall response (only Part 2)
timeFrame: Up to study completion (estimated time frame: 54 months)
measure: Percent change in the sum of diameters of target lesions (only Part 2)
timeFrame: Up to study completion (estimated time frame: 54 months)
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: Nagoya
country: Japan
facility: Aichi Clinical Site
state: Aichi
city: Hirosaki
country: Japan
facility: Aomori Clinical Site
state: Aomori
city: Misawa
country: Japan
facility: Aomori Clinical Site
state: Aomori
city: Funabashi
country: Japan
facility: Chiba Clinical Site
state: Chiba
city: Kamogawa
country: Japan
facility: Chiba Clinical Site
state: Chiba
city: Kashiwa
country: Japan
facility: Chiba Clinical Site
state: Chiba
city: Matsuyama
country: Japan
facility: Ehime Clinical Site1
state: Ehime
city: Matsuyama
country: Japan
facility: Ehime Clinical Site2
state: Ehime
city: Iizuka
country: Japan
facility: Fukuoka Clinical Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Fukuoka Clinical Site1
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Fukuoka Clinical Site2
state: Fukuoka
city: Kurume
country: Japan
facility: Fukuoka Clinical Site
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu Clinical Site
state: Gifu
city: Ogaki
country: Japan
facility: Gifu Clinical Site
state: Gifu
city: Maebashi
country: Japan
facility: Gumma Clinical Site
state: Gumma
city: Takasaki
country: Japan
facility: Gumma Clinical Site
state: Gumma
city: Ota
country: Japan
facility: Gunma Clinical Site
state: Gunma
city: Kure
country: Japan
facility: Hiroshima Clinical Site
state: Hiroshima
city: Hakodate
country: Japan
facility: Hokkaido Clinical Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido Clinical Site4
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site1
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site2
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site3
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Amagasaki
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Kobe
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Higashiibaraki-gun
country: Japan
facility: Ibaraki Clinical Site
state: Ibaraki
city: Tsuchiura-shi
country: Japan
facility: Ibaraki Clinical Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Ishikawa Clinical Site1
state: Ishikawa
city: Kanazawa
country: Japan
facility: Ishikawa Clinical Site2
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Clinical Site
state: Iwate
city: Kita-gun
country: Japan
facility: Kagawa Clinical Site
state: Kagawa
city: Isehara
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Kamakura
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 Site1
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site2
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site3
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Clinical Site
state: Miyagi
city: Osaki
country: Japan
facility: Miyagi Clinical Site
state: Miyagi
city: Sendai-shi
country: Japan
facility: Miyagi Clinical Site
state: Miyagi
city: Saku
country: Japan
facility: Nagano Clinical Site
state: Nagano
city: Ikoma
country: Japan
facility: Nara Clinical Site
state: Nara
city: Kashihara-shi
country: Japan
facility: Nara Clinical Site
state: Nara
city: Kurashiki
country: Japan
facility: Okayama Clinical Site
state: Okayama
city: Izumi
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Osakasayama
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: Hidaka
country: Japan
facility: Saitama Clinical Site
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Saitama Clinical Site
state: Saitama
city: Hamamatsu-shi
country: Japan
facility: Shizuoka Clinical Site
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Tochigi Clinical Site
state: Tochigi
city: Utsunomiya
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: Fuchu
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Clinical Site1
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Clinical Site2
state: Tokyo
city: Tachikawa
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Yonago
country: Japan
facility: Tottori Clinical Site
state: Tottori
city: Sakata
country: Japan
facility: Yamagata Clinical Site
state: Yamagata
city: Akita
country: Japan
facility: Akita Clinical Site
city: Chiba
country: Japan
facility: Chiba Clinical Site1
city: Chiba
country: Japan
facility: Chiba Clinical Site2
city: Fukui
country: Japan
facility: Fukui Clinical Site
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site1
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site2
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site3
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site4
city: Fukushima
country: Japan
facility: Fukushima 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: Kumamoto
country: Japan
facility: Kumamoto Clinical Site1
city: Kumamoto
country: Japan
facility: Kumamoto Clinical Site2
city: Kumamoto
country: Japan
facility: Kumamoto Clinical Site3
city: Kyoto
country: Japan
facility: Kyoto Clinical Site1
city: Kyoto
country: Japan
facility: Kyoto Clinical Site2
city: Kyoto
country: Japan
facility: Kyoto Clinical Site3
city: Niigata
country: Japan
facility: Niigata Clinical Site
city: Okayama
country: Japan
facility: Okayama 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: Tokushima
country: Japan
facility: Tokushima 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 Site
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site 1
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site 2
city: Daejeon
country: Korea, Republic of
facility: Daejeon 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: Gyeongnam
country: Korea, Republic of
facility: Gyeongnam Clinical Site
city: Incheon
country: Korea, Republic of
facility: Incheon Clinical Site
city: Jeollabuk-Do
country: Korea, Republic of
facility: Jeollabuk-Do Clinical Site
city: Jeollanam-do
country: Korea, Republic of
facility: Jeollanam-do Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 1
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 2
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 3
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 4
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 5
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 6
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site7
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site8
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site9
city: Ulsan
country: Korea, Republic of
facility: Ulsan Clinical Site
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site1
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site2
city: New Taipei
country: Taiwan
facility: New Taipei Clinical Site 1
city: Taichung
country: Taiwan
facility: Taichung Clinical Site 1
city: Taichung
country: Taiwan
facility: Taichung Clinical Site2
city: Tainan
country: Taiwan
facility: Tainan Clinical Site1
city: Tainan
country: Taiwan
facility: Tainan Clinical Site2
city: Taipei
country: Taiwan
facility: Taipei Clinical Site1
city: Taipei
country: Taiwan
facility: Taipei Clinical Site2
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, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):234-247. doi: 10.1016/S1470-2045(21)00692-6. Epub 2022 Jan 11.
citation: Boku N, Ryu MH, Kato K, Chung HC, Minashi K, Lee KW, Cho H, Kang WK, Komatsu Y, Tsuda M, Yamaguchi K, Hara H, Fumita S, Azuma M, Chen LT, Kang YK. Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4). Ann Oncol. 2019 Feb 1;30(2):250-258. doi: 10.1093/annonc/mdy540.