Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

June 12, 2022 updated by: Ono Pharmaceutical Co. Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

419

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense C, Denmark, 5000
        • Odense University Hospital
  • Germany
      • Aachen, Germany, 52057
        • RWTH Aachen University
      • Berlin, Germany, D-13353
        • Charite Campus Virchow Klinikum
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg
      • Jena, Germany, 07747
        • Universitatsklinikum Jena, Innere Medizin II
      • Leipzig, Germany, 04103
        • MVZ Mitte
      • Mainz, Germany, 55131
        • University of Mainz Medical Center
      • Munich, Germany, 81675
        • Klinikum reechts der Isar, Technical University Munchen
  • Italy
      • Bergamo, Italy, 24127
        • HPG23
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale Tumori
      • Padova, Italy, 35128
        • IRCCS Istituto Oncologico Veneto IOV
  • Japan
      • Akita, Japan, 010-8543
        • Akita Clinical Site
      • Chiba, Japan, 260-0801
        • Chiba Clinical Site
      • Chiba, Japan, 260-8677
        • Chiba Clinical Site
      • Fukuoka, Japan, 812-8582
        • Fukuoka Clinical site
      • Fukushima, Japan, 960-1295
        • Fukushima Clinical Site
      • Hiroshima, Japan, 734-8551
        • Hiroshima Clinical Site
      • Kagoshima, Japan, 890-8520
        • Kagoshima Clinical Site
      • Kumamoto, Japan, 860-8556
        • Kumamoto Clinical site
      • Kyoto, Japan, 602-8566
        • Kyoto Clinical Site
      • Kyoto, Japan, 606-8507
        • Kyoto Clinical Site
      • Niigata, Japan, 951-8566
        • Niigata Clinical Site
      • Osaka, Japan, 537-8511
        • Osaka Clinical site
      • Shizuoka, Japan, 420-8527
        • Shizuoka Clinical site
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Clinical Site
      • Nagoya, Aichi, Japan, 466-8560
        • Aichi Clinical Site
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Aomori Clinical Site
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Chiba Clinical Site
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0288
        • Ehime Clinical Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido Clinical site
      • Sapporo, Hokkaido, Japan, 003-0027
        • Hokkaido Clinical site
    • Hyogo
      • Akashi, Hyogo, Japan, 673-0021
        • Hyogo Clinical Site
      • Kobe, Hyogo, Japan, 650-0047
        • Hyogo Clinical Site
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Kanagawa Clinical Site
      • Kawasaki, Kanagawa, Japan, 216-0015
        • Kanagawa Clinical Site
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Clinical Site
      • Yokohama, Kanagawa, Japan, 236-0004
        • Kanagawa Clinical Site
    • Mie
      • Tsu, Mie, Japan, 514-8507
        • Mie Clinical Site
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Miyagi Clinical Site
    • Nagano
      • Saku, Nagano, Japan, 385-0051
        • Nagano Clinical Site
    • Niigata
      • Nigatake, Niigata, Japan, 951-8520
        • Niigata Clinical Site
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
        • Osaka Clinical site
      • Suita, Osaka, Japan, 565-0871
        • Osaka Clinical site
      • Takatsuki, Osaka, Japan, 569-0801
        • Osaka Clinical site
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Clinical site
      • Kita-Adachi County, Saitama, Japan, 362-0806
        • Saitama Clinical site
    • Shizuoka
      • Suntou County, Shizuoka, Japan, 411-8777
        • Shizuoka Clinical site
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0431
        • Tochigi Clinical site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-0021
        • Tokyo Clinical site
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Tokyo Clinical site
      • Chuo-ku, Tokyo, Japan, 104-8560
        • Tokyo Clinical site
      • Koto-ku, Tokyo, Japan, 135-8550
        • Tokyo Clinical site
      • Meguro-ku, Tokyo, Japan, 152-8902
        • Tokyo Clinical site
      • Minato-ku, Tokyo, Japan, 105-8470
        • Tokyo Clinical site
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Tokyo Clinical site
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Tokyo Clinical site
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Clinical site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Busan Clinical Site
      • Daegu, Korea, Republic of, 41404
        • Daegu Clinical Site
      • Daegu, Korea, Republic of, 41931
        • Daegu Clinical Site
      • Daejeon, Korea, Republic of, 35015
        • Daejeon Clinical Site
      • Gyeonggi-do, Korea, Republic of, 13620
        • Gyeonggi-do Clinical Site
      • Hwasun-Gun, Korea, Republic of, 58128
        • Hwasun-Gun Clinical Site
      • Seoul, Korea, Republic of, 03080
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 03722
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 05505
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 06351
        • Seoul Clinical Site
      • Seoul, Korea, Republic of, 06591
        • Seoul Clinical Site
      • Ulsan, Korea, Republic of, 44033
        • Ulsan Clinical Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Clinical Site
      • Chiayi, Taiwan, 61363
        • Chiayi Clinical Site
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Clinical Site
      • Kaohsiung, Taiwan, 82445
        • Kaohsiung Clinical Site
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Clinical Site
      • Keelung, Taiwan, 20445
        • Keelung Clinical Site
      • Taichung, Taiwan, 40447
        • Taichung Clinical Site
      • Tainan, Taiwan, 704
        • Tainan Clinical Site
      • Taipei, Taiwan, 10048
        • Taipei Clinical Site
      • Taipei, Taiwan, 11217
        • Taipei Clinical Site
      • Taoyuan, Taiwan, 333
        • Taoyuan Clinical Site
  • United Kingdom
    • Cardiganshire
      • Cardiff, Cardiganshire, United Kingdom, CF142TL
        • Velindre Cancer Centre
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Med Ctr
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health, Inc
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Ctr
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivolumab Arm
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Drug: Nivolumab
Active Comparator: Active Comparator Arm （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
Drug: Docetaxel/Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
("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

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
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.
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.
Duration of Response
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd., Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2015

Primary Completion (Actual)

October 23, 2020

Study Completion (Actual)

October 23, 2020

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4538-24/CA209-473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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