Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
ONO-4538 Phase III Study A Multicenter, Randomized, Open-label Study in Patients With Esophageal Cancer Refractory or Intolerant to Combination Therapy With Fluoropyrimidine and Platinum-based Drugs
1 other identifier
interventional
419
8 countries
89
Brief Summary
The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2015
Longer than P75 for phase_3
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedStudy Start
First participant enrolled
December 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2020
CompletedResults Posted
Study results publicly available
January 14, 2022
CompletedJuly 6, 2022
January 1, 2022
4.9 years
September 30, 2015
October 20, 2021
June 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive.
Secondary Outcomes (2)
Progression-free Survival
("Earlier date on which either the overall response was assessed as PD or the subject died of any cause" - "Date of randomization" + 1) / 30.4375.
Duration of Response
("Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause" - "Date of first assessment of confirmed CR or PR" + 1) / 30.4375.
Study Arms (2)
Nivolumab Arm
EXPERIMENTALNivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Active Comparator Arm （Docetaxel/Paclitaxel）
ACTIVE COMPARATORDocetaxel: 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
Interventions
Eligibility Criteria
You may qualify if:
- Men \& women ≥20 years of age
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ono Pharmaceutical Co. Ltdlead
- Bristol-Myers Squibbcollaborator
Study Sites (89)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Georgetown University Med Ctr
Washington D.C., District of Columbia, 20007, United States
Orlando Health, Inc
Orlando, Florida, 32806, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, 37232, United States
The University Of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Odense University Hospital
Odense C, 5000, Denmark
RWTH Aachen University
Aachen, 52057, Germany
Charite Campus Virchow Klinikum
Berlin, D-13353, Germany
University Hospital Heidelberg
Heidelberg, 69120, Germany
Universitatsklinikum Jena, Innere Medizin II
Jena, 07747, Germany
MVZ Mitte
Leipzig, 04103, Germany
University Of Mainz Medical Center
Mainz, 55131, Germany
Klinikum reechts der Isar, Technical University Munchen
Munich, 81675, Germany
HPG23
Bergamo, 24127, Italy
Fondazione Irccs Istituto Nazionale Tumori
Milan, 20133, Italy
Irccs Istituto Oncologico Veneto Iov
Padua, 35128, Italy
Aichi Clinical Site
Nagoya, Aichi-ken, 464-8681, Japan
Aichi Clinical Site
Nagoya, Aichi-ken, 466-8560, Japan
Aomori Clinical Site
Hirosaki, Aomori, 036-8563, Japan
Chiba Clinical Site
Kashiwa, Chiba, 277-8577, Japan
Ehime Clinical Site
Matsuyama, Ehime, 791-0288, Japan
Hokkaido Clinical Site
Sapporo, Hokkaido, 003-0027, Japan
Hokkaido Clinical Site
Sapporo, Hokkaido, 060-8648, Japan
Hyogo Clinical Site
Akashi, Hyōgo, 673-0021, Japan
Hyogo Clinical Site
Kobe, Hyōgo, 650-0047, Japan
Kanagawa Clinical Site
Isehara, Kanagawa, 259-1193, Japan
Kanagawa Clinical Site
Kawasaki, Kanagawa, 216-0015, Japan
Kanagawa Clinical Site
Yokohama, Kanagawa, 236-0004, Japan
Kanagawa Clinical Site
Yokohama, Kanagawa, 241-8515, Japan
Mie Clinical Site
Tsu, Mie-ken, 514-8507, Japan
Miyagi Clinical Site
Sendai, Miyagi, 980-8574, Japan
Nagano Clinical Site
Saku, Nagano, 385-0051, Japan
Niigata Clinical Site
Nigatake, Niigata, 951-8520, Japan
Osaka Clinical Site
Sayama, Osaka, 589-8511, Japan
Osaka Clinical Site
Suita, Osaka, 565-0871, Japan
Osaka Clinical Site
Takatsuki, Osaka, 569-0801, Japan
Saitama Clinical Site
Hidaka, Saitama, 350-1298, Japan
Saitama Clinical Site
Kita-Adachi County, Saitama, 362-0806, Japan
Shizuoka Clinical Site
Suntou County, Shizuoka, 411-8777, Japan
Tochigi Clinical Site
Shimotsuke, Tochigi, 329-0431, Japan
Tokyo Clinical Site
Bunkyo-ku, Tokyo, 113-0021, Japan
Tokyo Clinical Site
Chuo-ku, Tokyo, 104-0045, Japan
Tokyo Clinical Site
Chuo-ku, Tokyo, 104-8560, Japan
Tokyo Clinical Site
Koto-ku, Tokyo, 135-8550, Japan
Tokyo Clinical Site
Meguro-ku, Tokyo, 152-8902, Japan
Tokyo Clinical Site
Minato-ku, Tokyo, 105-8470, Japan
Tokyo Clinical Site
Shinagawa-ku, Tokyo, 142-8666, Japan
Tokyo Clinical Site
Shinjuku-ku, Tokyo, 160-8582, Japan
Tokyo Clinical Site
Shinjuku-ku, Tokyo, 162-8666, Japan
Akita Clinical Site
Akita, 010-8543, Japan
Chiba Clinical Site
Chiba, 260-0801, Japan
Chiba Clinical Site
Chiba, 260-8677, Japan
Fukuoka Clinical Site
Fukuoka, 812-8582, Japan
Fukushima Clinical Site
Fukushima, 960-1295, Japan
Hiroshima Clinical Site
Hiroshima, 734-8551, Japan
Kagoshima Clinical Site
Kagoshima, 890-8520, Japan
Kumamoto Clinical Site
Kumamoto, 860-8556, Japan
Kyoto Clinical Site
Kyoto, 602-8566, Japan
Kyoto Clinical Site
Kyoto, 606-8507, Japan
Niigata Clinical Site
Niigata, 951-8566, Japan
Osaka Clinical Site
Osaka, 537-8511, Japan
Shizuoka Clinical Site
Shizuoka, 420-8527, Japan
Busan Clinical Site
Busan, 49241, South Korea
Daegu Clinical Site
Daegu, 41404, South Korea
Daegu Clinical Site
Daegu, 41931, South Korea
Daejeon Clinical Site
Daejeon, 35015, South Korea
Gyeonggi-do Clinical Site
Gyeonggi-do, 13620, South Korea
Hwasun-Gun Clinical Site
Hwasun-Gun, 58128, South Korea
Seoul Clinical Site
Seoul, 03080, South Korea
Seoul Clinical Site
Seoul, 03722, South Korea
Seoul Clinical Site
Seoul, 05505, South Korea
Seoul Clinical Site
Seoul, 06351, South Korea
Seoul Clinical Site
Seoul, 06591, South Korea
Ulsan Clinical Site
Ulsan, 44033, South Korea
Changhua Clinical Site
Changhua, 500, Taiwan
Chiayi Clinical Site
Chiayi City, 61363, Taiwan
Kaohsiung Clinical Site
Kaohsiung City, 807, Taiwan
Kaohsiung Clinical Site
Kaohsiung City, 82445, Taiwan
Kaohsiung Clinical Site
Kaohsiung City, 83301, Taiwan
Keelung Clinical Site
Keelung, 20445, Taiwan
Taichung Clinical Site
Taichung, 40447, Taiwan
Tainan Clinical Site
Tainan, 704, Taiwan
Taipei Clinical Site
Taipei, 10048, Taiwan
Taipei Clinical Site
Taipei, 11217, Taiwan
Taoyuan Clinical Site
Taoyuan District, 333, Taiwan
Velindre Cancer Centre
Cardiff, Cardiganshire, CF142TL, United Kingdom
The Beatson West Of Scotland Cancer Centre
Glasgow, Lanarkshire, G12 0YN, United Kingdom
Related Publications (1)
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.
PMID: 31582355DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Center
- Organization
- Ono Pharmaceutical Co. Ltd
Study Officials
- STUDY DIRECTOR
Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd.
Ono Pharmaceutical Co. Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 6, 2015
Study Start
December 14, 2015
Primary Completion
October 23, 2020
Study Completion
October 23, 2020
Last Updated
July 6, 2022
Results First Posted
January 14, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share