Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ONO-4538
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
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
Sites / Locations
- Aichi Clinical Site
- Aomori Clinical Site
- Ehime Clinical Site
- Hokkaido Clinical Site
- Hyogo Clinical Site
- Hyogo Clinical Site
- Ishikawa Clinical Site
- Kanagawa Clinical Site
- Kanagawa Clinical Site
- Kanagawa Clinical Site
- Nagano Clinical Site
- Osaka Clinical Site
- Osaka Clinical Site
- Osaka Clinical Site
- Saitama Clinical Site
- Shizuoka Clinical Site
- Tochigi Clinical Site
- Tokyo Clinical Site
- Tokyo Clinical Site
- Tokyo Clinical Site
- Tokyo Clinical Site
- Chiba Clinical Site
- Fukuoka Clinical Site
- Fukuoka Clinical Site
- Gifu Clinical Site
- Hiroshima Clinical Site
- Osaka Clinical Site
- Shizuoka Clinical Site
- Busan-si Clinical Site
- Daegu Clinical Site
- Gyeonggi-Do Clinical Site
- Gyeonggi-Do Clinical Site
- Seoul Clinical Site
- Seoul Clinical Site
- Seoul Clinical Site
- Seoul Clinical Site
- Seoul Clinical Site
- Seoul Clinical Site
- Seoul Clinical Site
- Seoul Clinical Site
- Kaohsiung Clinical Site
- Kaohsiung Clinical Site
- Taichung Clinical Site
- Tainan Clinical Site
- Taipei Clinical Site
- Taipei Clinical Site
- Taipei Clinical Site
- Taipei Clinical Site
- Taoyuan Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ONO-4538 Arm
Placebo Arm
Arm Description
ONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Progression-free survival
Objective response rate
Duration of response
Safety will be analyzed through the incidence of adverse events, serious adverse events
Safety will be analyzed through the incidence of laboratory abnormalities
Full Information
NCT ID
NCT02267343
First Posted
October 9, 2014
Last Updated
November 16, 2021
Sponsor
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02267343
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
January 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
493 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ONO-4538 Arm
Arm Type
Experimental
Arm Description
ONO-4538 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Intervention Type
Drug
Intervention Name(s)
ONO-4538
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Up to study completion (estimated time frame: 30 months), every 2 weeks in principle
Title
Objective response rate
Time Frame
Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Title
Duration of response
Time Frame
Up to study completion (estimated time frame: 30 months), every 6 weeks in principle
Title
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time Frame
Continuously throughout study treatment and up to 28 days from last dose
Title
Safety will be analyzed through the incidence of laboratory abnormalities
Time Frame
Continuously throughout study treatment and up to 28 days from last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsunobu Tanimoto
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Clinical Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Aomori Clinical Site
City
Misawa
State/Province
Aomori
ZIP/Postal Code
033-0022
Country
Japan
Facility Name
Ehime Clinical Site
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Hokkaido Clinical Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hyogo Clinical Site
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Hyogo Clinical Site
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Ishikawa Clinical Site
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Nagano Clinical Site
City
Saku
State/Province
Nagano
ZIP/Postal Code
385-0051
Country
Japan
Facility Name
Osaka Clinical Site
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka Clinical Site
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Osaka Clinical Site
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saitama Clinical Site
City
Kitaadachi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Clinical Site
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Clinical Site
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokyo Clinical Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Tokyo Clinical Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Tokyo Clinical Site
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Tokyo Clinical Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Chiba Clinical Site
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gifu Clinical Site
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Hiroshima Clinical Site
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Osaka Clinical Site
City
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Shizuoka Clinical Site
City
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Busan-si Clinical Site
City
Busan-si
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Daegu Clinical Site
City
Daegu
ZIP/Postal Code
702-210
Country
Korea, Republic of
Facility Name
Gyeonggi-Do Clinical Site
City
Gyeonggi-Do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Gyeonggi-Do Clinical Site
City
Gyeonggi-Do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Kaohsiung Clinical Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Clinical Site
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Taichung Clinical Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Tainan Clinical Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Clinical Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Clinical Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Taipei Clinical Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Taipei Clinical Site
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Facility Name
Taoyuan Clinical Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing URL
https://www.ono.co.jp/eng/rd/policy.html
Citations:
PubMed Identifier
35383114
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.
Results Reference
derived
PubMed Identifier
28993052
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.
Results Reference
derived
Learn more about this trial
Study of ONO-4538 in Unresectable Advanced or Recurrent Gastric Cancer
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