Study of Adjuvant ONO-4538 With Resected Gastric Cancer

Sponsor
Ono Pharmaceutical Co. Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03006705
Collaborator
Bristol-Myers Squibb (Industry)
800
108
2
72.9
7.4
0.1

Study Details

Study Description

Brief Summary

The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy
Actual Study Start Date :
Jan 31, 2017
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nivolumab group

Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

Drug: Nivolumab
Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
Other Names:
  • BMS-936558
  • ONO-4538
  • MDX-1106
  • Drug: Tegafur-gimeracil-oteracil potassium
    Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off

    Drug: Oxaliplatin
    Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.

    Drug: Capecitabine
    Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

    Placebo Comparator: Placebo group

    Placebo: Placebo solution intravenously for 30 min in every 3 weeks (maximum 1 year). Chemotherapy: S-1 Therapy or CapeOX Therapy is determined by the investigator. S-1 therapy(maximum 1 year): Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off CapeOX Therapy(maximum 6 months): Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off. Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

    Drug: Tegafur-gimeracil-oteracil potassium
    Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off

    Drug: Oxaliplatin
    Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.

    Drug: Capecitabine
    Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.

    Drug: Placebo
    Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).

    Outcome Measures

    Primary Outcome Measures

    1. Relapse-free survival (RFS) [5 years]

    Secondary Outcome Measures

    1. Overall survival (OS) [5 years]

    2. 3-year OS rate [3 years]

    3. 5-year OS rate [5 years]

    4. 3-year RFS rate [3 years]

    5. 5-year RFS rate [5 years]

    6. Safety will be analyzed through the incidence of adverse events, serious adverse events [Up to 28 days from last dose]

    7. Safety will be analyzed through the incidence of laboratory abnormalities [Up to 28 days from last dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with histologically confirmed adenocarcinoma of the stomach

    • Patients without a remnant cancer (R0) who have undergone gastrectomy

    • Gastric carcinoma according to the stage classification of AJCC/UICC TNM Classification, 7th Edition on the basis of overall postoperative findings

    • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

    Exclusion Criteria:
    • Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric cancer

    • Multiple primary cancers

    • A current or past history of severe hypersensitivity to any other antibody products

    • Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Province Clinical Site Anhui Province China
    2 Beijing Clinical Site1 Beijing China
    3 Beijing Clinical Site2 Beijing China
    4 Cuangdong Province Clinical Site Cuangdong Province China
    5 Guangdong Province Clinical Site1 Guangdong Province China
    6 Guangdong Province Clinical Site2 Guangdong Province China
    7 Henan Province Clinical Site1 Henan Province China
    8 Henan Province Clinical Site2 Henan Province China
    9 Jiangsu Province Clinical Site1 Jiangsu Province China
    10 Jiangsu Province Clinical Site3 Jiangsu Province China
    11 Jiangsu Province Clinical Site4 Jiangsu Province China
    12 Jiangsu Province Clinical Site5 Jiangsu Province China
    13 Jiangsu Province Clinical Site6 Jiangsu Province China
    14 Jiangxi Province Clinical Site2 Jiangxi Province China
    15 Jilin Province Clinical Site Jilin Province China
    16 Liaoning Province Clinical Site Liaoning Province China
    17 Shanxi Province Clinical Site Shanxi Province China
    18 Tianjin Clinical Site1 Tianjin China
    19 Tianjin Clinical Site2 Tianjin China
    20 Zhejiang Province Clinical Site Zhejiang Province China
    21 Zhengjiang Province Clinical Site Zhengjiang Province China
    22 Aichi Clinical Site1 Nagoya Aichi Japan
    23 Aichi Clinical Site2 Nagoya Aichi Japan
    24 Chiba Clinical Site Kamogawa Chiba Japan
    25 Ehime Clinical Site Matsuyama Ehime Japan
    26 Ehime Clinicla Site Matsuyama Ehime Japan
    27 Gifu Clinical Site Ōgaki Gifu Japan
    28 Gunma Clinical Site Ota Gunma Japan
    29 Gunma Clinical Site Takasaki Gunma Japan
    30 Hiroshima Clinical Site Fukuyama Hiroshima Japan
    31 Hokkaido Clinical Site 3 Hakodate Hokkaido Japan
    32 Hokkaido Clinical Site 1 Sapporo Hokkaido Japan
    33 Hokkaido Clinical Site2 Sapporo Hokkaido Japan
    34 Hyogo Clinical Site Akashi Hyogo Japan
    35 Hyogo Clinical Site Amagasaki Hyogo Japan
    36 Hyogo Clinical Site Nishinomiya Hyogo Japan
    37 Ishikawa Clinical Site Kanazawa Ishikawa Japan
    38 Iwate Clinical Site Morioka Iwate Japan
    39 Kanagawa Clinical Site Sagamihara Kanagawa Japan
    40 Kanagawa Clinical Site Yokohama Kanagawa Japan
    41 Miyagi Clinical Site Osaki Miyagi Japan
    42 Nagano Clinical Site Saku Nagano Japan
    43 Okayama Clinical Site Kurashiki Okayama Japan
    44 Osaka Clinical Site Hirakata Osaka Japan
    45 Osaka Clinical Site Sakai Osaka Japan
    46 Osaka Clinical Site Suita Osaka Japan
    47 Osaka Clinical Site Takatsuki Osaka Japan
    48 Osaka Clinical Site Toyonaka Osaka Japan
    49 Osaka Clinical Site Ōsaka-sayama Osaka Japan
    50 Saitama Clinical Site Hidaka Saitama Japan
    51 Saitama Clinical Site Kitaadachi-gun Saitama Japan
    52 Shizuoka Clinical Site Sunto-gun Shizuoka Japan
    53 Tochigi Clinical Site Shimotsuke Tochigi Japan
    54 Tokyo Clinical Site Bunkyo-ku Tokyo Japan
    55 Tokyo Clinical Site Chuo-ku Tokyo Japan
    56 Tokyo Clinical Site Koto-ku Tokyo Japan
    57 Tokyo Clinical Site Shinjuku-ku Tokyo Japan
    58 Chiba Clinical Site Chiba Japan
    59 Fukuoka Clinical Site 1 Fukuoka Japan
    60 Fukuoka Clinical Site 2 Fukuoka Japan
    61 Gifu Clinical Site Gifu Japan
    62 Hiroshima Clinical Site1 Hiroshima Japan
    63 Hiroshima Clinical Site2 Hiroshima Japan
    64 Hiroshima Clinical Site3 Hiroshima Japan
    65 Kochi Clinical Site Kochi Japan
    66 Kumamoto Clinical Site Kumamoto Japan
    67 Kyoto Clinical Site Kyoto Japan
    68 Niigata Clinical Site Niigata Japan
    69 Osaka Clinical Site1 Osaka Japan
    70 Osaka Clinical Site2 Osaka Japan
    71 Osaka Clinical Site3 Osaka Japan
    72 Osaka Clinical Site4 Osaka Japan
    73 Shizuoka Clinical Site Shizuoka Japan
    74 Toyama Clinical Site Toyama Japan
    75 Wakayama Clinical Site Wakayama Japan
    76 Yamagata Clinical Site Yamagata Japan
    77 Busan Clinical Site1 Busan Korea, Republic of
    78 Busan Clinical Site2 Busan Korea, Republic of
    79 Busan Clinical Site3 Busan Korea, Republic of
    80 Daegu Clinical Site1 Daegu Korea, Republic of
    81 Daegu Clinical Site2 Daegu Korea, Republic of
    82 Daegu Clinical Site3 Daegu Korea, Republic of
    83 Daejeon Clinical Site 1 Daejeon Korea, Republic of
    84 Daejeon Clinical Site 2 Daejeon Korea, Republic of
    85 Gwangju Clinical Site Gwangju Korea, Republic of
    86 Gyeonggi-do Clinical Site1 Gyeonggi-do Korea, Republic of
    87 Gyeonggi-do Clinical Site2 Gyeonggi-do Korea, Republic of
    88 Gyeonggi-do Clinical Site3 Gyeonggi-do Korea, Republic of
    89 Gyeonggi-do Clinical Site4 Gyeonggi-do Korea, Republic of
    90 Gyeonggi-do Clinical Site5 Gyeonggi-do Korea, Republic of
    91 Jeollabuk-do Clinical Site Jeollabuk-do Korea, Republic of
    92 Seoul Clinical Site 8 Seoul Korea, Republic of
    93 Seoul Clinical Site 9 Seoul Korea, Republic of
    94 Seoul Clinical Site1 Seoul Korea, Republic of
    95 Seoul Clinical Site2 Seoul Korea, Republic of
    96 Seoul Clinical Site3 Seoul Korea, Republic of
    97 Seoul Clinical Site4 Seoul Korea, Republic of
    98 Seoul Clinical Site5 Seoul Korea, Republic of
    99 Seoul Clinical Site6 Seoul Korea, Republic of
    100 Seoul Clinical Site7 Seoul Korea, Republic of
    101 Kaohsiung Clinical Site2 Kaohsiung Taiwan
    102 Kaohsiung Clinical Site Kaohsiung Taiwan
    103 New Taipei Clinical Site New Taipei Taiwan
    104 Taichung Clinical Site Taichung Taiwan
    105 Tainan Clinical Site2 Tainan Taiwan
    106 Tainan Clinical Site Tainan Taiwan
    107 Taipei Clinical Site1 Taipei Taiwan
    108 Taipei Clinical Site2 Taipei Taiwan

    Sponsors and Collaborators

    • Ono Pharmaceutical Co. Ltd
    • Bristol-Myers Squibb

    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:
    NCT03006705
    Other Study ID Numbers:
    • ONO-4538-38
    First Posted:
    Dec 30, 2016
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ono Pharmaceutical Co. Ltd
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2022