Clinical trial NCT02569242: Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2015-10-06
Enrollment: 419
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Overall Survival
timeFrame: ("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:
measure: Progression-free Survival
timeFrame: ("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.
measure: Duration of Response
timeFrame: ("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.
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Washington
country: United States
facility: Georgetown University Med Ctr
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Ctr
state: Tennessee
city: Houston
country: United States
facility: The University Of Texas MD Anderson Cancer Center
state: Texas
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Aachen
country: Germany
facility: RWTH Aachen University
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Jena
country: Germany
facility: Universitatsklinikum Jena, Innere Medizin II
city: Leipzig
country: Germany
facility: MVZ Mitte
city: Mainz
country: Germany
facility: University Of Mainz Medical Center
city: Munich
country: Germany
facility: Klinikum reechts der Isar, Technical University Munchen
city: Bergamo
country: Italy
facility: HPG23
city: Milan
country: Italy
facility: Fondazione Irccs Istituto Nazionale Tumori
city: Padova
country: Italy
facility: Irccs Istituto Oncologico Veneto Iov
city: Nagoya
country: Japan
facility: Aichi Clinical Site
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Clinical Site
state: Aichi
city: Hirosaki
country: Japan
facility: Aomori Clinical Site
state: Aomori
city: Kashiwa
country: Japan
facility: Chiba Clinical Site
state: Chiba
city: Matsuyama
country: Japan
facility: Ehime Clinical Site
state: Ehime
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Clinical Site
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Kobe
country: Japan
facility: Hyogo Clinical Site
state: Hyogo
city: Isehara
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site
state: Kanagawa
city: Tsu
country: Japan
facility: Mie Clinical Site
state: Mie
city: Sendai
country: Japan
facility: Miyagi Clinical Site
state: Miyagi
city: Saku
country: Japan
facility: Nagano Clinical Site
state: Nagano
city: Nigatake
country: Japan
facility: Niigata Clinical Site
state: Niigata
city: Osakasayama
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Suita
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Clinical Site
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Clinical Site
state: Saitama
city: Kita-Adachi County
country: Japan
facility: Saitama Clinical Site
state: Saitama
city: Suntou County
country: Japan
facility: Shizuoka Clinical Site
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Tochigi Clinical Site
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Clinical Site
state: Tokyo
city: Akita
country: Japan
facility: Akita Clinical Site
city: Chiba
country: Japan
facility: Chiba Clinical Site
city: Chiba
country: Japan
facility: Chiba Clinical Site
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site
city: Fukushima
country: Japan
facility: Fukushima Clinical Site
city: Hiroshima
country: Japan
facility: Hiroshima Clinical Site
city: Kagoshima
country: Japan
facility: Kagoshima Clinical Site
city: Kumamoto
country: Japan
facility: Kumamoto Clinical Site
city: Kyoto
country: Japan
facility: Kyoto Clinical Site
city: Kyoto
country: Japan
facility: Kyoto Clinical Site
city: Niigata
country: Japan
facility: Niigata Clinical Site
city: Osaka
country: Japan
facility: Osaka Clinical Site
city: Shizuoka
country: Japan
facility: Shizuoka Clinical Site
city: Busan
country: Korea, Republic of
facility: Busan Clinical Site
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site
city: Daegu
country: Korea, Republic of
facility: Daegu Clinical Site
city: Daejeon
country: Korea, Republic of
facility: Daejeon Clinical Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Gyeonggi-do Clinical Site
city: Hwasun-Gun
country: Korea, Republic of
facility: Hwasun-Gun Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site
city: Ulsan
country: Korea, Republic of
facility: Ulsan Clinical Site
city: Changhua
country: Taiwan
facility: Changhua Clinical Site
city: Chiayi
country: Taiwan
facility: Chiayi Clinical Site
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Clinical Site
city: Keelung
country: Taiwan
facility: Keelung Clinical Site
city: Taichung
country: Taiwan
facility: Taichung Clinical Site
city: Tainan
country: Taiwan
facility: Tainan Clinical Site
city: Taipei
country: Taiwan
facility: Taipei Clinical Site
city: Taipei
country: Taiwan
facility: Taipei Clinical Site
city: Taoyuan
country: Taiwan
facility: Taoyuan Clinical Site
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
state: Cardiganshire
city: Glasgow
country: United Kingdom
facility: The Beatson West Of Scotland Cancer Centre
state: Lanarkshire
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References:
citation: 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.