An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)
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| ClinicalTrials.gov Identifier: NCT02743494 |
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Recruitment Status :
Active, not recruiting
First Posted : April 19, 2016
Results First Posted : June 22, 2021
Last Update Posted : September 18, 2023
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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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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Advanced Cancer |
| Interventions |
Drug: Nivolumab Other: Placebo |
| Enrollment | 794 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 794 participants were randomized and 792 were treated. The reasons for the 2 participants not being treated were: Participant request to discontinue study treatment (1) and Participant no longer meeting study criteria (1). |
| Arm/Group Title | Nivolumab | Placebo |
|---|---|---|
 Arm/Group Description |
Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles | Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles |
| Period Title: Pre-treatment Period | ||
| Started [1] | 532 | 262 |
| Completed [2] | 532 | 260 |
| Not Completed | 0 | 2 |
| Reason Not Completed | ||
| Participant request to discontinue treatment | 0 | 1 |
| Participant no longer meeting study criteria | 0 | 1 |
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[1]
Started = randomized
[2]
Completed = Entering the treatment period
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| Period Title: Treatment Period | ||
| Started | 532 | 260 |
| Completed [1] | 31 | 19 |
| Not Completed | 501 | 241 |
| Reason Not Completed | ||
| Completed treatment | 229 | 99 |
| Disease recurrence | 149 | 113 |
| Study drug toxicity | 57 | 8 |
| Death | 1 | 0 |
| Adverse event unrelated to study drug | 15 | 9 |
| Participant request to discontinue treatment | 30 | 5 |
| Participant withdrew consent | 12 | 4 |
| Lost to Follow-up | 0 | 1 |
| Poor/Non-compliance | 1 | 0 |
| Other reasons | 7 | 2 |
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[1]
Completed = continuing in the treatment
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Baseline Characteristics
| Arm/Group Title | Nivolumab | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles | Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles | Total of all reporting groups | |
| Overall Number of Baseline Participants | 532 | 262 | 794 | |
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Baseline Analysis Population Description |
All randomized participants
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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 532 participants | 262 participants | 794 participants | |
| 60.8 (9.2) | 59.9 (10.1) | 60.5 (9.5) | ||
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[1]
Measure Description: All randomized participants
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 532 participants | 262 participants | 794 participants | |
| Female |
83 15.6%
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40 15.3%
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123 15.5%
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| Male |
449 84.4%
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222 84.7%
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671 84.5%
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[1]
Measure Description: All randomized participants
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Ethnicity (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 532 participants | 262 participants | 794 participants | |
| Hispanic or Latino |
33 6.2%
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11 4.2%
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44 5.5%
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| Not Hispanic or Latino |
268 50.4%
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144 55.0%
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412 51.9%
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| Unknown or Not Reported |
231 43.4%
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107 40.8%
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338 42.6%
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[1]
Measure Description: All randomized participants
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 532 participants | 262 participants | 794 participants | |
| White |
432 81.2%
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216 82.4%
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648 81.6%
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| Black or African American |
7 1.3%
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2 0.8%
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9 1.1%
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| Asian |
83 15.6%
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34 13.0%
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117 14.7%
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| American Indian or Alaska Native |
0 0.0%
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2 0.8%
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2 0.3%
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| Other |
10 1.9%
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7 2.7%
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17 2.1%
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| Not Reported |
0 0.0%
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1 0.4%
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1 0.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title: | Bristol-Myers Squibb Study Director |
| Organization: | Bristol-Myers Squibb |
| Phone: | Please email |
| EMail: | Clinical.Trials@bms.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02743494 |
| Other Study ID Numbers: |
CA209-577 2015-005556-10 ( EudraCT Number ) |
| First Submitted: | April 15, 2016 |
| First Posted: | April 19, 2016 |
| Results First Submitted: | May 6, 2021 |
| Results First Posted: | June 22, 2021 |
| Last Update Posted: | September 18, 2023 |