Trial · NCT02743494

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

NCT02743494, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2021-06-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer. Trials, record NCT02743494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02743494

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
NCT number: NCT02743494
Status: Completed
Phases: Phase 3
Enrollment: 794 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Advanced Cancer
Interventions: Nivolumab, Placebo
First posted: 2016-04-19
Last updated: 2025-11-18
Other registries' IDs: eudract:2015-005556-10
Results first posted: 2021-06-22

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-free Survival (DFS)	From randomization to the date of recurrence or death (up to approximately 46 months)	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
Secondary	Overall Survival (OS)	From randomization to the date of death (up to approximately 60 months)	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.
Secondary	Overall Survival Rates at 12-, 24-, and 36-months	At 12-, 24- and 36-months post first dose.	Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival (DFS)	From randomization to the date of recurrence or death (up to approximately 46 months)	All randomized participants	Months	MEDIAN
SECONDARY	Overall Survival (OS)	From randomization to the date of death (up to approximately 60 months)	All randomized participants.	Months	MEDIAN
SECONDARY	Overall Survival Rates at 12-, 24-, and 36-months	At 12-, 24- and 36-months post first dose.	All randomized participants.	Percent of participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Disease-free Survival (DFS)	Nivolumab		22.41	95% Confidence Interval 16.62 to 34.00	Months
Disease-free Survival (DFS)	Placebo		11.04	95% Confidence Interval 8.34 to 14.32	Months
Overall Survival (OS)	Nivolumab		51.71	Full Range 41.03 to 61.63	Months
Overall Survival (OS)	Placebo		35.25	Full Range 30.72 to 48.76	Months
Overall Survival Rates at 12-, 24-, and 36-months	Nivolumab	12-months	87.5	95% Confidence Interval 84.4 to 90.0	Percent of participants
Overall Survival Rates at 12-, 24-, and 36-months	Placebo	12-months	84.6	95% Confidence Interval 79.6 to 88.4	Percent of participants
Overall Survival Rates at 12-, 24-, and 36-months	Nivolumab	24-months	68.1	95% Confidence Interval 63.9 to 71.9	Percent of participants
Overall Survival Rates at 12-, 24-, and 36-months	Placebo	24-months	65.8	95% Confidence Interval 59.6 to 71.2	Percent of participants
Overall Survival Rates at 12-, 24-, and 36-months	Nivolumab	36-months	56.9	95% Confidence Interval 52.5 to 61.0	Percent of participants
Overall Survival Rates at 12-, 24-, and 36-months	Placebo	36-months	49.7	95% Confidence Interval 43.5 to 55.7	Percent of participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pre-treatment Period	STARTED	Nivolumab	532
Pre-treatment Period	STARTED	Placebo	262
Pre-treatment Period	COMPLETED	Nivolumab	532
Pre-treatment Period	COMPLETED	Placebo	260
Pre-treatment Period	NOT COMPLETED	Nivolumab	0
Pre-treatment Period	NOT COMPLETED	Placebo	2
Treatment Period	STARTED	Nivolumab	532
Treatment Period	STARTED	Placebo	260
Treatment Period	COMPLETED	Nivolumab	260
Treatment Period	COMPLETED	Placebo	116

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events496

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Nivolumab	50	532
other	Anaemia	Blood and lymphatic system disorders	Placebo	22	260
other	Hyperthyroidism	Endocrine disorders	Nivolumab	44	532
other	Hyperthyroidism	Endocrine disorders	Placebo	2	260
other	Hypothyroidism	Endocrine disorders	Nivolumab	67	532
other	Hypothyroidism	Endocrine disorders	Placebo	7	260
other	Abdominal pain	Gastrointestinal disorders	Nivolumab	71	532
other	Abdominal pain	Gastrointestinal disorders	Placebo	39	260
other	Abdominal pain upper	Gastrointestinal disorders	Nivolumab	21	532
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	19	260

1 to 10 of 496Source ClinicalTrials.gov

See all 496 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nivolumab	299	532
Total, all-cause mortality	Placebo	162	262
Total, other adverse events	Nivolumab	470	532
Total, other adverse events	Placebo	216	260
Total, serious adverse events	Nivolumab	196	532
Total, serious adverse events	Placebo	99	260

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33789008	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nivolumab vs Placebo: deaths from any cause	Trial comparisons
Nivolumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02743494

GET https://conductscience.org/api/trials/v1/NCT02743494/events?page=2

API reference For AI assistants