Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569242
• Other study ID #: ONO-4538-24/CA209-473
• Status: Completed
• Phase: Phase 3
• Start date: December 14, 2015
• Est. completion date: October 23, 2020

Study information

• Verified date: January 2022
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Nivolumab

• Docetaxel/Paclitaxel

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense C
Germany	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
Italy	HPG23	Bergamo
Italy	Fondazione Irccs Istituto Nazionale Tumori	Milan
Italy	Irccs Istituto Oncologico Veneto Iov	Padova
Japan	Hyogo Clinical Site	Akashi	Hyogo
Japan	Akita Clinical Site	Akita
Japan	Tokyo Clinical Site	Bunkyo-ku	Tokyo
Japan	Chiba Clinical Site	Chiba
Japan	Chiba Clinical Site	Chiba
Japan	Tokyo Clinical Site	Chuo-ku	Tokyo
Japan	Tokyo Clinical Site	Chuo-ku	Tokyo
Japan	Fukuoka Clinical Site	Fukuoka
Japan	Fukushima Clinical Site	Fukushima
Japan	Saitama Clinical Site	Hidaka	Saitama
Japan	Aomori Clinical Site	Hirosaki	Aomori
Japan	Hiroshima Clinical Site	Hiroshima
Japan	Kanagawa Clinical Site	Isehara	Kanagawa
Japan	Kagoshima Clinical Site	Kagoshima
Japan	Chiba Clinical Site	Kashiwa	Chiba
Japan	Kanagawa Clinical Site	Kawasaki	Kanagawa
Japan	Saitama Clinical Site	Kita-Adachi County	Saitama
Japan	Hyogo Clinical Site	Kobe	Hyogo
Japan	Tokyo Clinical Site	Koto-ku	Tokyo
Japan	Kumamoto Clinical Site	Kumamoto
Japan	Kyoto Clinical Site	Kyoto
Japan	Kyoto Clinical Site	Kyoto
Japan	Ehime Clinical Site	Matsuyama	Ehime
Japan	Tokyo Clinical Site	Meguro-ku	Tokyo
Japan	Tokyo Clinical Site	Minato-ku	Tokyo
Japan	Aichi Clinical Site	Nagoya	Aichi
Japan	Aichi Clinical Site	Nagoya	Aichi
Japan	Niigata Clinical Site	Nigatake	Niigata
Japan	Niigata Clinical Site	Niigata
Japan	Osaka Clinical Site	Osaka
Japan	Osaka Clinical Site	Osakasayama	Osaka
Japan	Nagano Clinical Site	Saku	Nagano
Japan	Hokkaido Clinical Site	Sapporo	Hokkaido
Japan	Hokkaido Clinical Site	Sapporo	Hokkaido
Japan	Miyagi Clinical Site	Sendai	Miyagi
Japan	Tochigi Clinical Site	Shimotsuke	Tochigi
Japan	Tokyo Clinical Site	Shinagawa-ku	Tokyo
Japan	Tokyo Clinical Site	Shinjuku-ku	Tokyo
Japan	Tokyo Clinical Site	Shinjuku-ku	Tokyo
Japan	Shizuoka Clinical Site	Shizuoka
Japan	Osaka Clinical Site	Suita	Osaka
Japan	Shizuoka Clinical Site	Suntou County	Shizuoka
Japan	Osaka Clinical Site	Takatsuki	Osaka
Japan	Mie Clinical Site	Tsu	Mie
Japan	Kanagawa Clinical Site	Yokohama	Kanagawa
Japan	Kanagawa Clinical Site	Yokohama	Kanagawa
Korea, Republic of	Busan Clinical Site	Busan
Korea, Republic of	Daegu Clinical Site	Daegu
Korea, Republic of	Daegu Clinical Site	Daegu
Korea, Republic of	Daejeon Clinical Site	Daejeon
Korea, Republic of	Gyeonggi-do Clinical Site	Gyeonggi-do
Korea, Republic of	Hwasun-Gun Clinical Site	Hwasun-Gun
Korea, Republic of	Seoul Clinical Site	Seoul
Korea, Republic of	Seoul Clinical Site	Seoul
Korea, Republic of	Seoul Clinical Site	Seoul
Korea, Republic of	Seoul Clinical Site	Seoul
Korea, Republic of	Seoul Clinical Site	Seoul
Korea, Republic of	Ulsan Clinical Site	Ulsan
Taiwan	Changhua Clinical Site	Changhua
Taiwan	Chiayi Clinical Site	Chiayi
Taiwan	Kaohsiung Clinical Site	Kaohsiung
Taiwan	Kaohsiung Clinical Site	Kaohsiung
Taiwan	Kaohsiung Clinical Site	Kaohsiung
Taiwan	Keelung Clinical Site	Keelung
Taiwan	Taichung Clinical Site	Taichung
Taiwan	Tainan Clinical Site	Tainan
Taiwan	Taipei Clinical Site	Taipei
Taiwan	Taipei Clinical Site	Taipei
Taiwan	Taoyuan Clinical Site	Taoyuan
United Kingdom	Velindre Cancer Centre	Cardiff	Cardiganshire
United Kingdom	The Beatson West Of Scotland Cancer Centre	Glasgow	Lanarkshire
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke Cancer Institute	Durham	North Carolina
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	The University Of Texas MD Anderson Cancer Center	Houston	Texas
United States	Vanderbilt-Ingram Cancer Ctr	Nashville	Tennessee
United States	Orlando Health, Inc	Orlando	Florida
United States	Georgetown University Med Ctr	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Denmark,  Germany,  Italy,  Japan,  Korea, Republic of,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free Survival	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)."	("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.
Secondary	Duration of Response	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)."	("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.