TriangleNCT02743494 · CITED IN SOURCE DOCUMENTS
An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-11-18
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction * Completed pre-operative chemo radiotherapy followed by surgery * Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection Exclusion Criteria: * Diagnosed with cervical esophageal carcinoma * Diagnosed with Stage IV resectable disease * Did not receive concurrent chemoradiotherapy prior to surgery * Participants who have received a live/attenuated vaccine within 30 days of the first treatment Other protocol defined Inclusion/exclusion criteria could apply
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Nivolumab
- label
- Nivolumab
- type
- EXPERIMENTAL
- intervention Names
- Other: Placebo
- label
- Placebo
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Nivolumab
- description
- Specified dose on specified days
- name
- Nivolumab
- type
- DRUG
- arm Group Labels
- Placebo
- description
- Specified dose on specified days
- name
- Placebo
- type
- OTHER
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 794
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first. Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment
- measure
- Disease-free Survival (DFS)
- time Frame
- From randomization to the date of recurrence or death (up to approximately 46 months)
- secondary Outcomes
- description
- Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.
- measure
- Overall Survival (OS)
- time Frame
- From randomization to the date of death (up to approximately 60 months)
- description
- Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization
- measure
- Overall Survival Rates at 12-, 24-, and 36-months
- time Frame
- At 12-, 24- and 36-months post first dose.
Full study description
- brief Summary
- The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Source references
- references
- citation
- Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125.
- pmid
- 33789008
- type
- DERIVED
- see Also Links
- label
- BMS Clinical Trial Information
- label
- BMS Clinical Trial Patient Recruiting
Source notices and limitations
Discovery and provenance
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- the adequate and well-controlled study of intravenous nivolumab in this esophageal or gastroesophageal junction cancer population. CHECKMATE-577 CHECKMATE-577 (NCT02743494) was a randomized, multicenter, double-blind trial in 794 patients with completely resected (negative margins) esophageal or gastroesophageal junction cancer w
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- response 6 (12%) Partial response 11 (22%) 14.13 Esophageal Cancer Adjuvant Treatment of Resected Esophageal or Gastroesophageal Junction Cancer CHECKMATE-577 (NCT02743494) was a randomized, multicenter, double-blind trial in 794 patients with completely resected (negative margins) esophageal or gastroesophageal junction cancer w
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Preserved source evidence · Not medical advice