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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)

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: NCT02872116
Recruitment Status : Active, not recruiting
First Posted : August 19, 2016
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 19, 2016
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE October 4, 2016
Estimated Primary Completion Date March 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Overall survival (OS) of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in programmed cell death ligand 1 (PD-L1) positive participants [ Time Frame: Up to 53 months after the first participant is randomized ]
  • Progression-free survival (PFS), as assessed by Blinded Independent Central Review (BICR), of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in PD-L1 positive participants [ Time Frame: Up to 53 months after the first participant is randomized ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
Overall survival (OS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in subjects with programmed cell death ligand 1 (PD-L1) expressing tumors [ Time Frame: Approximately 35 months after the first patient is randomized ]
Change History Complete list of historical versions of study NCT02872116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • OS in all randomized participants [ Time Frame: Up to 53 months after the first participant is randomized ]
  • PFS, as assessed by BICR, in all randomized participants [ Time Frame: Up to 53 months after the first participant is randomized ]
  • Objective Response Rate (ORR), as assessed by BICR, in all randomized participants [ Time Frame: Up to 53 months after the first participant is randomized ]
  • Time to symptom deterioration (TTSD) of nivolumab + ipilimumab vs oxaliplatin + fluoropyrimidine in all randomized participants [ Time Frame: Up to 53 months after the first participant is randomized ]
    Time to Symptom Deterioration assessed with Gastric Cancer Subscale questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2016)
  • OS of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in all randomized subjects [ Time Frame: Approximately 35 months after the first patient is randomized ]
  • Progression-free Survival (PFS) of nivolumab + ipilimumab versus oxaliplatin + fluoropyrimidine in subjects with PD-L1 expressing tumors and all randomized subjects [ Time Frame: Approximately 35 months after the first patient is randomized ]
  • Time to Symptom Deterioration (TTSD) assessed with Gastric Cancer Subscale (GaCS) questionnaire in subjects with PD-L1 expressing tumors and all randomized subjects [ Time Frame: Approximately 35 months after the first patient is randomized ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Gastroesophageal Junction Cancer
Intervention  ICMJE
  • Drug: Nivolumab
    Specified dose on specified days
    Other Names:
    • Opdivo
    • BMS-936558
  • Drug: Ipilimumab
    Specified dose on specified days
    Other Names:
    • Yervoy
    • BMS-734016
  • Drug: Oxaliplatin
    Specified dose on specified days
  • Drug: Capecitabine
    Specified dose on specified days
  • Drug: Leucovorin
    Specified dose on specified days
  • Drug: Fluorouracil
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Nivolumab + Ipilimumab

    Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy

    Enrollment is closed for this arm

    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • Active Comparator: XELOX (Oxaliplatin + Capecitabine)
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Capecitabine
  • Active Comparator: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: Fluorouracil
  • Experimental: Nivolumab + XELOX
    Interventions:
    • Drug: Nivolumab
    • Drug: Oxaliplatin
    • Drug: Capecitabine
  • Experimental: Nivolumab + FOLFOX
    Interventions:
    • Drug: Nivolumab
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: Fluorouracil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
2005
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2016)
750
Estimated Study Completion Date  ICMJE October 6, 2022
Estimated Primary Completion Date March 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Chile,   China,   Colombia,   Czechia,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02872116
Other Study ID Numbers  ICMJE CA209-649
2016-001018-76 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP