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 October 2017 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02872116
First Posted: August 19, 2016
Last Update Posted: October 4, 2017
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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:
Drug: Ipilimumab
Specified dose on specified days
Other Names:
|
| 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:
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:
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 166 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: | October 4, 2017 |
| Last Verified: | October 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 |