Trial · NCT03143153

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

NCT03143153, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2022-03-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin. Trials, record NCT03143153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03143153

On this page

Trial

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

Title: A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin
NCT number: NCT03143153
Status: Completed
Phases: Phase 3
Enrollment: 970 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Various Advanced Cancer
Interventions: Nivolumab, Ipilimumab, Cisplatin, Fluorouracil
First posted: 2017-05-08
Last updated: 2026-02-17
Other registries' IDs: eudract:2016-001514-20
Results first posted: 2022-03-02

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Overall Survival (OS) in Participants With Tumor Cell PD-L1	From the date of randomization to up to the date of death (up to approximately 20 months)	Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Primary	Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1	From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months)	Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
Secondary	Overall Survival (OS) in All Randomized Participants	From the date of randomization to up to the date of death (up to approximately 88 months)	Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Secondary	Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR	From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 88 months)	Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
Secondary	Objective Response Rate (ORR) as Assessed by BICR	From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 88 months)	Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS) in Participants With Tumor Cell PD-L1	From the date of randomization to up to the date of death (up to approximately 20 months)	All randomized PD-L1 expressing participants	Months	MEDIAN
PRIMARY	Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1	From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months)	All randomized PD-L1 expressing participants	Months	MEDIAN
SECONDARY	Overall Survival (OS) in All Randomized Participants	From the date of randomization to up to the date of death (up to approximately 88 months)	All randomized participants	Months	MEDIAN
SECONDARY	Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR	From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 88 months)	All randomized participants	Months	MEDIAN
SECONDARY	Objective Response Rate (ORR) as Assessed by BICR	From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 88 months)	All randomized PD-L1 expressing participants and all randomized participants	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group35

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

Outcome	Group	Value	Spread	Units
Overall Survival (OS) in Participants With Tumor Cell PD-L1	Arm A: Nivolumab + Ipilimumab	13.70	95% Confidence Interval 11.24 to 17.02	Months
Overall Survival (OS) in Participants With Tumor Cell PD-L1	Arm B: Nivolumab + Chemotherapy	15.44	95% Confidence Interval 11.93 to 19.52	Months
Overall Survival (OS) in Participants With Tumor Cell PD-L1	Arm C: Chemotherapy	9.07	95% Confidence Interval 7.69 to 9.95	Months
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1	Arm A: Nivolumab + Ipilimumab	4.04	95% Confidence Interval 2.40 to 4.93	Months
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1	Arm B: Nivolumab + Chemotherapy	6.93	95% Confidence Interval 5.68 to 8.34	Months
Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1	Arm C: Chemotherapy	4.44	95% Confidence Interval 2.89 to 5.82	Months
Overall Survival (OS) in All Randomized Participants	Arm A: Nivolumab + Ipilimumab	12.747	95% Confidence Interval 11.269 to 15.474	Months
Overall Survival (OS) in All Randomized Participants	Arm B: Nivolumab + Chemotherapy	13.207	95% Confidence Interval 11.105 to 15.671	Months
Overall Survival (OS) in All Randomized Participants	Arm C: Chemotherapy	10.710	95% Confidence Interval 9.396 to 12.090	Months
Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR	Arm A: Nivolumab + Ipilimumab	2.891	95% Confidence Interval 2.661 to 4.172	Months

1 to 10 of 35Source ClinicalTrials.gov

See all 35 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Pre-Treatment	STARTED	Arm A: Nivolumab + Ipilimumab	325
Pre-Treatment	STARTED	Arm B: Nivolumab + Chemotherapy	321
Pre-Treatment	STARTED	Arm C: Chemotherapy	324
Pre-Treatment	COMPLETED	Arm A: Nivolumab + Ipilimumab	322
Pre-Treatment	COMPLETED	Arm B: Nivolumab + Chemotherapy	310
Pre-Treatment	COMPLETED	Arm C: Chemotherapy	304
Pre-Treatment	NOT COMPLETED	Arm A: Nivolumab + Ipilimumab	3
Pre-Treatment	NOT COMPLETED	Arm B: Nivolumab + Chemotherapy	11
Pre-Treatment	NOT COMPLETED	Arm C: Chemotherapy	20
Treatment	STARTED	Arm A: Nivolumab + Ipilimumab	322

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events1,212

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	Arm A: Nivolumab + Ipilimumab	84	322
other	Anaemia	Blood and lymphatic system disorders	Arm B: Nivolumab + Chemotherapy	156	310
other	Anaemia	Blood and lymphatic system disorders	Arm C: Chemotherapy	108	304
other	Neutropenia	Blood and lymphatic system disorders	Arm A: Nivolumab + Ipilimumab	6	322
other	Neutropenia	Blood and lymphatic system disorders	Arm B: Nivolumab + Chemotherapy	38	310
other	Neutropenia	Blood and lymphatic system disorders	Arm C: Chemotherapy	23	304
other	Hyperthyroidism	Endocrine disorders	Arm A: Nivolumab + Ipilimumab	20	322
other	Hyperthyroidism	Endocrine disorders	Arm B: Nivolumab + Chemotherapy	7	310
other	Hyperthyroidism	Endocrine disorders	Arm C: Chemotherapy	1	304
other	Hypothyroidism	Endocrine disorders	Arm A: Nivolumab + Ipilimumab	44	322

1 to 10 of 1,212Source ClinicalTrials.gov

See all 1,212 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Nivolumab + Ipilimumab	270	325
Total, all-cause mortality	Arm B: Nivolumab + Chemotherapy	273	321
Total, all-cause mortality	Arm C: Chemotherapy	286	324
Total, other adverse events	Arm A: Nivolumab + Ipilimumab	301	322
Total, other adverse events	Arm B: Nivolumab + Chemotherapy	307	310
Total, other adverse events	Arm C: Chemotherapy	288	304
Total, serious adverse events	Arm A: Nivolumab + Ipilimumab	243	322
Total, serious adverse events	Arm B: Nivolumab + Chemotherapy	226	310
Total, serious adverse events	Arm C: Chemotherapy	174	304

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35108470	DERIVED	PubMed
36401133	DERIVED	PubMed
37139963	DERIVED	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 comparisons0

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

None in this release.

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.

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