Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
NCT ID: NCT02569242
Last Updated: 2022-07-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
419 participants
INTERVENTIONAL
2015-12-14
2020-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nivolumab Arm
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Nivolumab
Active Comparator Arm （Docetaxel/Paclitaxel）
Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
OR
Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Docetaxel/Paclitaxel
Interventions
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Nivolumab
Docetaxel/Paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed unresectable advanced or recurrent esophageal cancer
* Refractory to or intolerant of standard therapy
* ECOG Performance Status score 0 or 1
* A life expectancy of at least 3 months
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd.
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Georgetown University Med Ctr
Washington D.C., District of Columbia, United States
Orlando Health, Inc
Orlando, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Duke Cancer Institute
Durham, North Carolina, United States
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States
Odense University Hospital
Odense C, , Denmark
RWTH Aachen University
Aachen, , Germany
Charite Campus Virchow Klinikum
Berlin, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Universitatsklinikum Jena, Innere Medizin II
Jena, , Germany
MVZ Mitte
Leipzig, , Germany
University Of Mainz Medical Center
Mainz, , Germany
Klinikum reechts der Isar, Technical University Munchen
Munich, , Germany
HPG23
Bergamo, , Italy
Fondazione Irccs Istituto Nazionale Tumori
Milan, , Italy
Irccs Istituto Oncologico Veneto Iov
Padua, , Italy
Aichi Clinical Site
Nagoya, Aichi-ken, Japan
Aichi Clinical Site
Nagoya, Aichi-ken, Japan
Aomori Clinical Site
Hirosaki, Aomori, Japan
Chiba Clinical Site
Kashiwa, Chiba, Japan
Ehime Clinical Site
Matsuyama, Ehime, Japan
Hokkaido Clinical Site
Sapporo, Hokkaido, Japan
Hokkaido Clinical Site
Sapporo, Hokkaido, Japan
Hyogo Clinical Site
Akashi, Hyōgo, Japan
Hyogo Clinical Site
Kobe, Hyōgo, Japan
Kanagawa Clinical Site
Isehara, Kanagawa, Japan
Kanagawa Clinical Site
Kawasaki, Kanagawa, Japan
Kanagawa Clinical Site
Yokohama, Kanagawa, Japan
Kanagawa Clinical Site
Yokohama, Kanagawa, Japan
Mie Clinical Site
Tsu, Mie-ken, Japan
Miyagi Clinical Site
Sendai, Miyagi, Japan
Nagano Clinical Site
Saku, Nagano, Japan
Niigata Clinical Site
Nigatake, Niigata, Japan
Osaka Clinical Site
Sayama, Osaka, Japan
Osaka Clinical Site
Suita, Osaka, Japan
Osaka Clinical Site
Takatsuki, Osaka, Japan
Saitama Clinical Site
Hidaka, Saitama, Japan
Saitama Clinical Site
Kita-Adachi County, Saitama, Japan
Shizuoka Clinical Site
Suntou County, Shizuoka, Japan
Tochigi Clinical Site
Shimotsuke, Tochigi, Japan
Tokyo Clinical Site
Bunkyo-ku, Tokyo, Japan
Tokyo Clinical Site
Chuo-ku, Tokyo, Japan
Tokyo Clinical Site
Chuo-ku, Tokyo, Japan
Tokyo Clinical Site
Koto-ku, Tokyo, Japan
Tokyo Clinical Site
Meguro-ku, Tokyo, Japan
Tokyo Clinical Site
Minato-ku, Tokyo, Japan
Tokyo Clinical Site
Shinagawa-ku, Tokyo, Japan
Tokyo Clinical Site
Shinjuku-ku, Tokyo, Japan
Tokyo Clinical Site
Shinjuku-ku, Tokyo, Japan
Akita Clinical Site
Akita, , Japan
Chiba Clinical Site
Chiba, , Japan
Chiba Clinical Site
Chiba, , Japan
Fukuoka Clinical Site
Fukuoka, , Japan
Fukushima Clinical Site
Fukushima, , Japan
Hiroshima Clinical Site
Hiroshima, , Japan
Kagoshima Clinical Site
Kagoshima, , Japan
Kumamoto Clinical Site
Kumamoto, , Japan
Kyoto Clinical Site
Kyoto, , Japan
Kyoto Clinical Site
Kyoto, , Japan
Niigata Clinical Site
Niigata, , Japan
Osaka Clinical Site
Osaka, , Japan
Shizuoka Clinical Site
Shizuoka, , Japan
Busan Clinical Site
Busan, , South Korea
Daegu Clinical Site
Daegu, , South Korea
Daegu Clinical Site
Daegu, , South Korea
Daejeon Clinical Site
Daejeon, , South Korea
Gyeonggi-do Clinical Site
Gyeonggi-do, , South Korea
Hwasun-Gun Clinical Site
Hwasun-Gun, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Seoul Clinical Site
Seoul, , South Korea
Ulsan Clinical Site
Ulsan, , South Korea
Changhua Clinical Site
Changhua, , Taiwan
Chiayi Clinical Site
Chiayi City, , Taiwan
Kaohsiung Clinical Site
Kaohsiung City, , Taiwan
Kaohsiung Clinical Site
Kaohsiung City, , Taiwan
Kaohsiung Clinical Site
Kaohsiung City, , Taiwan
Keelung Clinical Site
Keelung, , Taiwan
Taichung Clinical Site
Taichung, , Taiwan
Tainan Clinical Site
Tainan City, , Taiwan
Taipei Clinical Site
Taipei, , Taiwan
Taipei Clinical Site
Taipei, , Taiwan
Taoyuan Clinical Site
Taoyuan District, , Taiwan
Velindre Cancer Centre
Cardiff, Cardiganshire, United Kingdom
The Beatson West Of Scotland Cancer Centre
Glasgow, Lanarkshire, United Kingdom
Countries
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References
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Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y, Yen CC, Kubota Y, Kim SB, Hsu CH, Holtved E, Xynos I, Kodani M, Kitagawa Y. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1506-1517. doi: 10.1016/S1470-2045(19)30626-6. Epub 2019 Sep 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ONO-4538-24/CA209-473
Identifier Type: -
Identifier Source: org_study_id
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