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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)

This study is currently recruiting participants.
Verified December 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02872116
First Posted: August 19, 2016
Last Update Posted: December 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
Gastric Cancer Gastroesophageal Junction Cancer Drug: Nivolumab Drug: Ipilimumab Drug: Oxaliplatin Drug: Capecitabine Drug: Leucovorin Drug: Fluorouracil Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall survival (OS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in patients with programmed cell death ligand 1 (PD-L1) expressing tumors [ Time Frame: Approximately 40 months after the first patient is randomized ]
  • OS of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in patients with PD-L1 expressing tumors [ Time Frame: Approximately 40 months after the first patient is randomized ]

Secondary Outcome Measures:
  • OS of nivolumab + ipilimumab or nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in all randomized patients [ Time Frame: Approximately 40 months after the first patient is randomized ]
  • Progression-free Survival (PFS) of nivolumab + ipilimumab or nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in patients with PD-L1 expressing tumors and all randomized patients [ Time Frame: Approximately 40 months after the first patient is randomized ]
  • Time to Symptom Deterioration of nivolumab + ipilimumab or nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in patients with PD-L1 expressing tumors and all randomized patients [ Time Frame: Approximately 40 months after the first patient is randomized ]
    Time to Symptom Deterioration assessed with Gastric Cancer Subscale questionnaire


Estimated Enrollment: 1266
Actual Study Start Date: October 4, 2016
Estimated Study Completion Date: October 11, 2020
Estimated Primary Completion Date: July 11, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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 184 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02872116     History of Changes
Other Study ID Numbers: CA209-649
2016-001018-76 ( EudraCT Number )
First Submitted: August 16, 2016
First Posted: August 19, 2016
Last Update Posted: December 6, 2017
Last Verified: December 2017

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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs