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Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Docetaxel/Paclitaxel
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner MD Anderson Cancer Center
  • Georgetown University Med Ctr
  • Orlando Health, Inc
  • Massachusetts General Hospital
  • Duke Cancer Institute
  • Vanderbilt-Ingram Cancer Ctr
  • The University Of Texas MD Anderson Cancer Center
  • Odense University Hospital
  • RWTH Aachen University
  • Charite Campus Virchow Klinikum
  • University Hospital Heidelberg
  • Universitatsklinikum Jena, Innere Medizin II
  • MVZ Mitte
  • University Of Mainz Medical Center
  • Klinikum reechts der Isar, Technical University Munchen
  • HPG23
  • Fondazione Irccs Istituto Nazionale Tumori
  • Irccs Istituto Oncologico Veneto Iov
  • Aichi Clinical Site
  • Aichi Clinical Site
  • Aomori Clinical Site
  • Chiba Clinical Site
  • Ehime Clinical Site
  • Hokkaido Clinical Site
  • Hokkaido Clinical Site
  • Hyogo Clinical Site
  • Hyogo Clinical Site
  • Kanagawa Clinical Site
  • Kanagawa Clinical Site
  • Kanagawa Clinical Site
  • Kanagawa Clinical Site
  • Mie Clinical Site
  • Miyagi Clinical Site
  • Nagano Clinical Site
  • Niigata Clinical Site
  • Osaka Clinical Site
  • Osaka Clinical Site
  • Osaka Clinical Site
  • Saitama Clinical Site
  • Saitama Clinical Site
  • Shizuoka Clinical Site
  • Tochigi Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Tokyo Clinical Site
  • Akita Clinical Site
  • Chiba Clinical Site
  • Chiba Clinical Site
  • Fukuoka Clinical Site
  • Fukushima Clinical Site
  • Hiroshima Clinical Site
  • Kagoshima Clinical Site
  • Kumamoto Clinical Site
  • Kyoto Clinical Site
  • Kyoto Clinical Site
  • Niigata Clinical Site
  • Osaka Clinical Site
  • Shizuoka Clinical Site
  • Busan Clinical Site
  • Daegu Clinical Site
  • Daegu Clinical Site
  • Daejeon Clinical Site
  • Gyeonggi-do Clinical Site
  • Hwasun-Gun Clinical Site
  • Seoul Clinical Site
  • Seoul Clinical Site
  • Seoul Clinical Site
  • Seoul Clinical Site
  • Seoul Clinical Site
  • Ulsan Clinical Site
  • Changhua Clinical Site
  • Chiayi Clinical Site
  • Kaohsiung Clinical Site
  • Kaohsiung Clinical Site
  • Kaohsiung Clinical Site
  • Keelung Clinical Site
  • Taichung Clinical Site
  • Tainan Clinical Site
  • Taipei Clinical Site
  • Taipei Clinical Site
  • Taoyuan Clinical Site
  • Velindre Cancer Centre
  • The Beatson West Of Scotland Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nivolumab Arm

Active Comparator Arm （Docetaxel/Paclitaxel）

Arm Description

Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

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

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

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)."
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)."

Full Information

First Posted
September 30, 2015
Last Updated
June 12, 2022
Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02569242
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2015 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab Arm
Arm Type
Experimental
Arm Description
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Arm Title
Active Comparator Arm （Docetaxel/Paclitaxel）
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Type
Drug
Intervention Name(s)
Docetaxel/Paclitaxel
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
("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 Measure Information:
Title
Progression-free Survival
Description
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)."
Time Frame
("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.
Title
Duration of Response
Description
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)."
Time Frame
("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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd.
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Georgetown University Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Orlando Health, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The University Of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
RWTH Aachen University
City
Aachen
ZIP/Postal Code
52057
Country
Germany
Facility Name
Charite Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsklinikum Jena, Innere Medizin II
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
MVZ Mitte
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
University Of Mainz Medical Center
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum reechts der Isar, Technical University Munchen
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
HPG23
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Fondazione Irccs Istituto Nazionale Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Irccs Istituto Oncologico Veneto Iov
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Aichi Clinical Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Aichi Clinical Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Aomori Clinical Site
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Chiba Clinical Site
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Ehime Clinical Site
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0288
Country
Japan
Facility Name
Hokkaido Clinical Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0027
Country
Japan
Facility Name
Hokkaido Clinical Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Hyogo Clinical Site
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-0021
Country
Japan
Facility Name
Hyogo Clinical Site
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-0015
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kanagawa Clinical Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Mie Clinical Site
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Miyagi Clinical Site
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Nagano Clinical Site
City
Saku
State/Province
Nagano
ZIP/Postal Code
385-0051
Country
Japan
Facility Name
Niigata Clinical Site
City
Nigatake
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka Clinical Site
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka Clinical Site
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Osaka Clinical Site
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-0801
Country
Japan
Facility Name
Saitama Clinical Site
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Saitama Clinical Site
City
Kita-Adachi County
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Clinical Site
City
Suntou County
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Clinical Site
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0431
Country
Japan
Facility Name
Tokyo Clinical Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-0021
Country
Japan
Facility Name
Tokyo Clinical Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Tokyo Clinical Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Tokyo Clinical Site
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Tokyo Clinical Site
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Tokyo Clinical Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Tokyo Clinical Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Tokyo Clinical Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Tokyo Clinical Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Akita Clinical Site
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Chiba Clinical Site
City
Chiba
ZIP/Postal Code
260-0801
Country
Japan
Facility Name
Chiba Clinical Site
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Fukuoka Clinical Site
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukushima Clinical Site
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Hiroshima Clinical Site
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Kagoshima Clinical Site
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kumamoto Clinical Site
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto Clinical Site
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kyoto Clinical Site
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Niigata Clinical Site
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka Clinical Site
City
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Shizuoka Clinical Site
City
Shizuoka
ZIP/Postal Code
420-8527
Country
Japan
Facility Name
Busan Clinical Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Daegu Clinical Site
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Daegu Clinical Site
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Daejeon Clinical Site
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Gyeonggi-do Clinical Site
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Hwasun-Gun Clinical Site
City
Hwasun-Gun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul Clinical Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ulsan Clinical Site
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Changhua Clinical Site
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Chiayi Clinical Site
City
Chiayi
ZIP/Postal Code
61363
Country
Taiwan
Facility Name
Kaohsiung Clinical Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Clinical Site
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Facility Name
Kaohsiung Clinical Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Keelung Clinical Site
City
Keelung
ZIP/Postal Code
20445
Country
Taiwan
Facility Name
Taichung Clinical Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Tainan Clinical Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Clinical Site
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taipei Clinical Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Taoyuan Clinical Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Velindre Cancer Centre
City
Cardiff
State/Province
Cardiganshire
ZIP/Postal Code
CF142TL
Country
United Kingdom
Facility Name
The Beatson West Of Scotland Cancer Centre
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing URL
https://www.ono.co.jp/eng/rd/policy.html
Citations:
PubMed Identifier
31582355
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. Erratum In: Lancet Oncol. 2019 Nov;20(11):e613.
Results Reference
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Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

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