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Study of Adjuvant ONO-4538 With Resected Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03006705
Recruitment Status : Active, not recruiting
First Posted : December 30, 2016
Last Update Posted : March 13, 2023
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Study Description
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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
Gastric Cancer Drug: Nivolumab Drug: Tegafur-gimeracil-oteracil potassium Drug: Oxaliplatin Drug: Capecitabine Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 31, 2017
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Relapse-free survival (RFS) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 5 years ]
  2. 3-year OS rate [ Time Frame: 3 years ]
  3. 5-year OS rate [ Time Frame: 5 years ]
  4. 3-year RFS rate [ Time Frame: 3 years ]
  5. 5-year RFS rate [ Time Frame: 5 years ]
  6. Safety will be analyzed through the incidence of adverse events, serious adverse events [ Time Frame: Up to 28 days from last dose ]
  7. Safety will be analyzed through the incidence of laboratory abnormalities [ Time Frame: Up to 28 days from last dose ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006705


Locations
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Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Bristol-Myers Squibb
Investigators
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Study Director: Project Leader Ono Pharmaceutical Co. Ltd
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT03006705    
Other Study ID Numbers: ONO-4538-38
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: https://www.ono-pharma.com/en/company/policies/clinical_trial_data_transparency_policy.html

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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:
ONO-4538,BMS-936558,Nivolumab,gastric,adjuvant,S-1,CapeOX
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
 Tegafur
Oxaliplatin
Nivolumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors