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 |
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Recruitment Status :
Recruiting
First Posted : August 19, 2016
Last Update Posted : December 10, 2018
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Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2005 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 28, 2021 |
| Estimated Study Completion Date : | October 6, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Stomach Cancer
| Arm | Intervention/treatment |
|---|---|
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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:
Drug: Ipilimumab Specified dose on specified days
Other Names:
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| 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 |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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
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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
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 |
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 Posted: | August 19, 2016 Key Record Dates |
| Last Update Posted: | December 10, 2018 |
| Last Verified: | December 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
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 Fluorouracil |
Oxaliplatin Nivolumab Antibodies, Monoclonal Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents |