Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4538 Arm | Experimental | 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 Arm | Placebo Comparator | Placebo intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4538 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Up to study completion (estimated time frame: 30 months), every 2 weeks in principle |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Up to study completion (estimated time frame: 30 months), every 2 weeks in principle | |
| Objective response rate | Up to study completion (estimated time frame: 30 months), every 6 weeks in principle |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mitsunobu Tanimoto | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Clinical Site | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Aomori Clinical Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35383114 | Derived | 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. | |
| 28993052 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Duration of response | Up to study completion (estimated time frame: 30 months), every 6 weeks in principle |
| Safety will be analyzed through the incidence of adverse events, serious adverse events | Continuously throughout study treatment and up to 28 days from last dose |
| Safety will be analyzed through the incidence of laboratory abnormalities | Continuously throughout study treatment and up to 28 days from last dose |
| Misawa |
| Aomori |
| 033-0022 |
| Japan |
| Ehime Clinical Site | Matsuyama | Ehime | 791-0280 | Japan |
| Hokkaido Clinical Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Hyogo Clinical Site | Akashi | Hyōgo | 673-8558 | Japan |
| Hyogo Clinical Site | Kobe | Hyōgo | 650-0047 | Japan |
| Ishikawa Clinical Site | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kanagawa Clinical Site | Kawasaki | Kanagawa | 216-8511 | Japan |
| Kanagawa Clinical Site | Sagamihara | Kanagawa | 252-0375 | Japan |
| Kanagawa Clinical Site | Yokohama | Kanagawa | 241-8515 | Japan |
| Nagano Clinical Site | Saku | Nagano | 385-0051 | Japan |
| Osaka Clinical Site | Sayama | Osaka | 589-8511 | Japan |
| Osaka Clinical Site | Suita | Osaka | 565-0871 | Japan |
| Osaka Clinical Site | Takatsuki | Osaka | 569-8686 | Japan |
| Saitama Clinical Site | Kitaadachi | Saitama | 362-0806 | Japan |
| Shizuoka Clinical Site | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Tochigi Clinical Site | Shimotsuke | Tochigi | 329-0498 | Japan |
| Tokyo Clinical Site | Bunkyo-ku | Tokyo | 113-8677 | Japan |
| Tokyo Clinical Site | Chuo-ku | Tokyo | 104-0045 | Japan |
| Tokyo Clinical Site | Koto-ku | Tokyo | 135-8550 | Japan |
| Tokyo Clinical Site | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Chiba Clinical Site | Chiba | 260-8717 | Japan |
| Fukuoka Clinical Site | Fukuoka | 811-1395 | Japan |
| Fukuoka Clinical Site | Fukuoka | 812-8582 | Japan |
| Gifu Clinical Site | Gifu | 501-1194 | Japan |
| Hiroshima Clinical Site | Hiroshima | 730-8518 | Japan |
| Osaka Clinical Site | Osaka | 537-8511 | Japan |
| Shizuoka Clinical Site | Shizuoka | 420-8527 | Japan |
| Busan-si Clinical Site | Busan | 602-715 | South Korea |
| Daegu Clinical Site | Daegu | 702-210 | South Korea |
| Gyeonggi-Do Clinical Site | Gyeonggi-do | 410-769 | South Korea |
| Gyeonggi-Do Clinical Site | Gyeonggi-do | 463-707 | South Korea |
| Seoul Clinical Site | Seoul | 110-744 | South Korea |
| Seoul Clinical Site | Seoul | 120-752 | South Korea |
| Seoul Clinical Site | Seoul | 135-710 | South Korea |
| Seoul Clinical Site | Seoul | 135-720 | South Korea |
| Seoul Clinical Site | Seoul | 136-705 | South Korea |
| Seoul Clinical Site | Seoul | 137-701 | South Korea |
| Seoul Clinical Site | Seoul | 138-736 | South Korea |
| Seoul Clinical Site | Seoul | 152-703 | South Korea |
| Kaohsiung Clinical Site | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Clinical Site | Kaohsiung City | 833 | Taiwan |
| Taichung Clinical Site | Taichung | 40447 | Taiwan |
| Tainan Clinical Site | Tainan | 704 | Taiwan |
| Taipei Clinical Site | Taipei | 10002 | Taiwan |
| Taipei Clinical Site | Taipei | 112 | Taiwan |
| Taipei Clinical Site | Taipei | 114 | Taiwan |
| Taipei Clinical Site | Taipei | 116 | Taiwan |
| Taoyuan Clinical Site | Taoyuan | 333 | Taiwan |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided