Clinical Trials /

Study of Adjuvant ONO-4538 With Resected Gastric Cancer

NCT03006705

Description:

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.

Related Conditions:
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Adjuvant ONO-4538 With Resected Gastric Cancer
  • Official Title: A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: ONO-4538-38
  • NCT ID: NCT03006705

Conditions

  • Gastric Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558, ONO-4538, MDX-1106Nivolumab group
Tegafur-gimeracil-oteracil potassiumNivolumab group
OxaliplatinNivolumab group
CapecitabineNivolumab group
PlaceboPlacebo group

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab groupExperimentalNivolumab: 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.
  • Nivolumab
  • Tegafur-gimeracil-oteracil potassium
  • Oxaliplatin
  • Capecitabine
Placebo groupPlacebo ComparatorPlacebo: 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.
  • Tegafur-gimeracil-oteracil potassium
  • Oxaliplatin
  • Capecitabine
  • Placebo

Eligibility Criteria

        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
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Relapse-free survival (RFS)
Time Frame:5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:5 years
Safety Issue:
Description:
Measure:3-year OS rate
Time Frame:3 years
Safety Issue:
Description:
Measure:5-year OS rate
Time Frame:5 years
Safety Issue:
Description:
Measure:3-year RFS rate
Time Frame:3 years
Safety Issue:
Description:
Measure:5-year RFS rate
Time Frame:5 years
Safety Issue:
Description:
Measure:Safety will be analyzed through the incidence of adverse events, serious adverse events
Time Frame:Up to 28 days from last dose
Safety Issue:
Description:
Measure:Safety will be analyzed through the incidence of laboratory abnormalities
Time Frame:Up to 28 days from last dose
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ono Pharmaceutical Co. Ltd

Trial Keywords

  • ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX

Last Updated

May 21, 2020