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A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Sponsor
Ono Pharmaceutical Co. Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05144854
Collaborator
(none)
600
Enrollment
57
Locations
2
Arms
65.8
Anticipated Duration (Months)
10.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Actual Study Start Date :
Nov 5, 2021
Anticipated Primary Completion Date :
Feb 1, 2027
Anticipated Study Completion Date :
May 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: ONO-4538 + ipilimumab + chemotherapy

Drug: ONO-4538
Specified dose on specified days
Other Names:
  • Nivolumab
  • Opdivo

    • Drug: Ipilimumab
    Specified dose on specified days
    Other Names:
  • BMS-734016
  • Yervoy

    • Drug: Oxaliplatin
    Specified dose on specified days

    Drug: Capecitabine
    Specified dose on specified days

    Drug: S-1
    Specified dose on specified days
    Other Names:
  • Tegafur-gimeracil-oteracil potassium

    		•
    Active Comparator: Chemotherapy

    Drug: Oxaliplatin
    Specified dose on specified days

    Drug: Capecitabine
    Specified dose on specified days

    Drug: S-1
    Specified dose on specified days
    Other Names:
  • Tegafur-gimeracil-oteracil potassium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [up to 3 years]

    Secondary Outcome Measures

    1. Progression-free survival (PFS) (site investigator assessment) [up to 3 years]

    2. Objective response rate (ORR) (site investigator assessment) [up to 3 years]

    3. Best overall response (BOR) (site investigator assessment) [up to 3 years]

    4. Duration of response (DOR) (site investigator assessment) [up to 3 years]

    5. Disease control rate (DCR) (site investigator assessment) [up to 3 years]

    6. Time to response (TTR) (site investigator assessment) [up to 3 years]

    7. Maximum percent change in the sum diameters of the target lesions (site investigator assessment) [up to 3 years]

    8. Progression-free survival after the next line of therapy (PFS2) (site investigator assessment) [up to 3 years]

    9. Adverse event [Up to 30 days after the last dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma

    2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1

    3. Participants who have a life expectancy of at least 3 months

    Exclusion Criteria:

    1. Participants with a history or complications of multiple cancers

    2. Participants with a complication or history of severe hypersensitivity to any other antibody products

    3. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center Hospital East Kashiwa-shi Chiba Japan
    2 Kanagawa Cancer Center Yokohama-shi Kanagawa Japan
    3 Osaki Citizen Hospital Osaki-shi Miyagi Japan
    4 Osaka University Hospital Suita-shi Osaka Japan
    5 Saitama Medical University International Medical Center Hidaka-shi Saitama Japan
    6 Saitama Cancer Center Ina-machi, Kitaadati-gun Saitama Japan
    7 Shizuoka Cancer Center Nagaizumi-Cho, Sunto-Gun Shizuoka Japan
    8 University of Tokyo Hospital Bunkyo-ku Tokyo Japan
    9 National Cancer Center Hospital Chuo-ku Tokyo Japan
    10 Cancer Institute Hospital of JFCR Koto-ku Tokyo Japan
    11 IMSUT Hospital, The Institute of Medical Science, The University of Tokyo Minato-ku Tokyo Japan
    12 Keio University Hospital Shinjyuku-ku Tokyo Japan
    13 Chungbuk National University Hospital Cheongju-si Chungcheongbuk-do Korea, Republic of
    14 Kosin University Gospel Hospital Busan Gangwon-do Korea, Republic of
    15 Hallym University Sacred Heart Hospital Anyang-si Gyeonggi-do Korea, Republic of
    16 National Cancer Center Goyang-si Gyeonggi-do Korea, Republic of
    17 CHA Bundang Medical Center, CHA University Seongnam-si Gyeonggi-do Korea, Republic of
    18 Seoul National University Bundang Hospital Seongnam Gyeonggi-do Korea, Republic of
    19 The Catholic University of Korea, St. Vincent's Hospital Suwon-si Gyeonggi-do Korea, Republic of
    20 Ajou University Hospital Suwon Gyeonggi-do Korea, Republic of
    21 Kyungpook National University Chilgok Hospital Daegu Gyeongsangbuk-do Korea, Republic of
    22 Pusan National University Yangsan Hospital Yangsan-si Gyeongsangnam-do Korea, Republic of
    23 Jeonbuk national university hospital Jeonju-si Jeollabuk-do Korea, Republic of
    24 Chonnam National University Hwasun Hospital Hwasun-gun Jeollanam-do Korea, Republic of
    25 Dong-A University Hospital Busan Korea, Republic of
    26 Inje University Haeundae Paik Hospital Busan Korea, Republic of
    27 Pusan National University Hospital Busan Korea, Republic of
    28 Keimyung University Dongsan Hospital Daegu Korea, Republic of
    29 Chungnam National University Hospital Daejeon Korea, Republic of
    30 Konyang University Hospital Daejeon Korea, Republic of
    31 Gachon University Gil Medical Center Incheon Korea, Republic of
    32 Asan Medical Center Seoul Korea, Republic of
    33 Chung-Ang University Hospital Seoul Korea, Republic of
    34 Gangnam Severance Hospital, Yonsei University Health System Seoul Korea, Republic of
    35 Kangbuk Samsung Hospital Seoul Korea, Republic of
    36 Korea University Guro Hospital Seoul Korea, Republic of
    37 Samsung Medical Center Seoul Korea, Republic of
    38 Seoul National University Hospital Seoul Korea, Republic of
    39 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of
    40 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of
    41 Ulsan University Hospital Ulsan Korea, Republic of
    42 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan
    43 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan
    44 Chang Gung Memorial Hospital, Keelung Keelung City Taiwan
    45 Far Eastern Memorial Hospital New Taipei City Taiwan
    46 Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare New Taipei City Taiwan
    47 China Medical University Hospital Taichung Taiwan
    48 Taichung Veterans General Hospital Taichung Taiwan
    49 Chi Mei Hospital, Liouying Tainan Taiwan
    50 National Cheng Kung University Hospital Tainan Taiwan
    51 Taipei Medical University Hospital Taipei City Taiwan
    52 Koo Foundation Sun Yat-Sen Cancer Center Taipei Taiwan
    53 National Taiwan University Hospital Taipei Taiwan
    54 Taipei Municipal Wanfang Hospital Managed by Taipei Medical University Taipei Taiwan
    55 Taipei Veterans General Hospital Taipei Taiwan
    56 Tri-Service General Hospital Taipei Taiwan
    57 Chang Gung Memorial Hospital,Linkou Taoyuan County Taiwan

    Sponsors and Collaborators

    • Ono Pharmaceutical Co. Ltd

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ono Pharmaceutical Co. Ltd
    ClinicalTrials.gov Identifier:
    NCT05144854
    Other Study ID Numbers:
    • ONO-4538-113
    First Posted:
    Dec 3, 2021
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Capecitabine
    Tegafur
    Oxaliplatin
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Jun 3, 2022