Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
- Registration Number
- NCT02569242
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 419
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Comparator Arm （Docetaxel/Paclitaxel） 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 Nivolumab Arm Nivolumab Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."
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. Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."
Trial Locations
- Locations (58)
Orlando Health, Inc
🇺🇸Orlando, Florida, United States
Georgetown University Med Ctr
🇺🇸Washington, District of Columbia, United States
Universitatsklinikum Jena, Innere Medizin II
🇩🇪Jena, Germany
Klinikum reechts der Isar, Technical University Munchen
🇩🇪Munich, Germany
Charite Campus Virchow Klinikum
🇩🇪Berlin, Germany
Vanderbilt-Ingram Cancer Ctr
🇺🇸Nashville, Tennessee, United States
HPG23
🇮🇹Bergamo, Italy
Chiba Clinical Site
🇯🇵Chiba, Japan
University Of Mainz Medical Center
🇩🇪Mainz, Germany
Gyeonggi-do Clinical Site
🇰🇷Gyeonggi-do, Korea, Republic of
Velindre Cancer Centre
🇬🇧Cardiff, Cardiganshire, United Kingdom
University Hospital Heidelberg
🇩🇪Heidelberg, Germany
Kanagawa Clinical Site
🇯🇵Yokohama, Kanagawa, Japan
Fukuoka Clinical Site
🇯🇵Fukuoka, Japan
Keelung Clinical Site
🇨🇳Keelung, Taiwan
Fondazione Irccs Istituto Nazionale Tumori
🇮🇹Milan, Italy
Taoyuan Clinical Site
🇨🇳Taoyuan, Taiwan
Daejeon Clinical Site
🇰🇷Daejeon, Korea, Republic of
RWTH Aachen University
🇩🇪Aachen, Germany
MVZ Mitte
🇩🇪Leipzig, Germany
The University Of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
The Beatson West Of Scotland Cancer Centre
🇬🇧Glasgow, Lanarkshire, United Kingdom
Daegu Clinical Site
🇰🇷Daegu, Korea, Republic of
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Hiroshima Clinical Site
🇯🇵Hiroshima, Japan
Busan Clinical Site
🇰🇷Busan, Korea, Republic of
Ulsan Clinical Site
🇰🇷Ulsan, Korea, Republic of
Odense University Hospital
🇩🇰Odense C, Denmark
Aichi Clinical Site
🇯🇵Nagoya, Aichi, Japan
Aomori Clinical Site
🇯🇵Hirosaki, Aomori, Japan
Hyogo Clinical Site
🇯🇵Kobe, Hyogo, Japan
Osaka Clinical Site
🇯🇵Osaka, Japan
Kyoto Clinical Site
🇯🇵Kyoto, Japan
Chiayi Clinical Site
🇨🇳Chiayi, Taiwan
Miyagi Clinical Site
🇯🇵Sendai, Miyagi, Japan
Niigata Clinical Site
🇯🇵Niigata, Japan
Changhua Clinical Site
🇨🇳Changhua, Taiwan
Ehime Clinical Site
🇯🇵Matsuyama, Ehime, Japan
Saitama Clinical Site
🇯🇵Kita-Adachi County, Saitama, Japan
Mie Clinical Site
🇯🇵Tsu, Mie, Japan
Nagano Clinical Site
🇯🇵Saku, Nagano, Japan
Hokkaido Clinical Site
🇯🇵Sapporo, Hokkaido, Japan
Akita Clinical Site
🇯🇵Akita, Japan
Kagoshima Clinical Site
🇯🇵Kagoshima, Japan
Kumamoto Clinical Site
🇯🇵Kumamoto, Japan
Kaohsiung Clinical Site
🇨🇳Kaohsiung, Taiwan
Taichung Clinical Site
🇨🇳Taichung, Taiwan
Taipei Clinical Site
🇨🇳Taipei, Taiwan
Shizuoka Clinical Site
🇯🇵Shizuoka, Japan
Tochigi Clinical Site
🇯🇵Shimotsuke, Tochigi, Japan
Fukushima Clinical Site
🇯🇵Fukushima, Japan
Tainan Clinical Site
🇨🇳Tainan, Taiwan
Tokyo Clinical Site
🇯🇵Shinjuku-ku, Tokyo, Japan
Irccs Istituto Oncologico Veneto Iov
🇮🇹Padova, Italy
Seoul Clinical Site
🇰🇷Seoul, Korea, Republic of
Hwasun-Gun Clinical Site
🇰🇷Hwasun-Gun, Korea, Republic of
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States