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Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)

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ClinicalTrials.gov Identifier: NCT02872116
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastroesophageal Junction Cancer Drug: Nivolumab Drug: Ipilimumab Drug: Oxaliplatin Drug: Capecitabine Drug: Leucovorin Drug: Fluorouracil Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1649 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Actual Study Start Date : October 4, 2016
Estimated Primary Completion Date : March 12, 2020
Estimated Study Completion Date : October 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab

Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy

Enrollment is closed for this arm

 Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016
Active Comparator: XELOX (Oxaliplatin + Capecitabine) Drug: Oxaliplatin
Specified dose on specified days

Drug: Capecitabine
Specified dose on specified days
Active Comparator: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil) Drug: Oxaliplatin
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: Fluorouracil
Specified dose on specified days
Experimental: Nivolumab + XELOX Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Oxaliplatin
Specified dose on specified days

Drug: Capecitabine
Specified dose on specified days
Experimental: Nivolumab + FOLFOX Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: Oxaliplatin
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: Fluorouracil
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in participants with programmed cell death ligand 1 (PD-L1) expressing tumors [ Time Frame: Approximately 40 months after the first participant is randomized ]
  2. OS of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in all randomized participants [ Time Frame: Approximately 40 months after the first participant is randomized ]
  3. Objective Response Rate (ORR), as assessed by Blinded Independent Central Review (BICR), of nivolumab in combination with oxaliplatin plus fluoropyrimidine versus oxaliplatin plus fluoropyrimidine in all randomized participants [ Time Frame: Up to 40 months after the first participant is randomized ]
  4. Progression-free Survival (PFS), as assessed by BICR, of nivolumab in combination with oxaliplatin plus fluoropyrimidine versus oxaliplatin plus fluoropyrimidine in all randomized participants [ Time Frame: Up to 40 months after the first participant is randomized ]

Secondary Outcome Measures :
  1. OS of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in all randomized participants [ Time Frame: Approximately 40 months after the first participant is randomized ]
  2. PFS of nivolumab + ipilimumab or nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in participants with PD-L1 expressing tumors and all randomized participants [ Time Frame: Up to 40 months after the first participant is randomized ]
  3. Time to Symptom Deterioration of nivolumab + ipilimumab or nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in participants with PD-L1 expressing tumors and all randomized participants [ Time Frame: Approximately 40 months after the first participant is randomized ]
    Time to Symptom Deterioration assessed with Gastric Cancer Subscale questionnaire

  4. ORR, as assessed by investigator, of nivolumab in combination with oxaliplatin plus fluoropyrimidine versus oxaliplatin plus fluoropyrimidine in all randomized participants [ Time Frame: Up to 40 months after the first participant is randomized ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Male or Female at least 18 years of age
  • Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
  • Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria:

  • Presence of tumor cells in the brain or spinal cord that have not been treated
  • Active known or suspected autoimmune disease
  • Any serious or uncontrolled medical disorder or active infection
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Any positive test result for hepatitis B or C indicating acute or chronic infection

Other protocol defined inclusion/exclusion criteria could apply

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): NCT02872116


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 190 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site
Investigator Inquiry Form  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02872116     History of Changes
Other Study ID Numbers: CA209-649
2016-001018-76 ( EudraCT Number )
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Fluorouracil
 Oxaliplatin
Nivolumab
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents