Trial · NCT03189719

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)

NCT03189719, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-07-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590). Trials, record NCT03189719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03189719

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Trial

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

Title: First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)
NCT number: NCT03189719
Status: Completed
Phases: Phase 3
Enrollment: 749 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Esophageal Neoplasms
Interventions: Pembrolizumab, Placebo, Cisplatin, 5-FU
First posted: 2017-06-16
Last updated: 2024-10-15
Other registries' IDs: eudract:2017-000958-19
Results first posted: 2021-07-06

Source ClinicalTrials.gov

Registered outcomes25

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

List	Outcome	Time frame	Description
Primary	Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10)	Up to approximately 34 months	Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the Intent-To-Treat (ITT) population (all randomized) who had ESCC and who were PD-L1 CPS ≥10.
Primary	OS in Participants With ESCC	Up to approximately 34 months	Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized) who had ESCC.
Primary	OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	Up to approximately 34 months	Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10.
Primary	OS in All Participants	Up to approximately 34 months	Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized).
Primary	Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC	Up to approximately 34 months	PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who had ESCC.
Primary	PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	Up to approximately 34 months	PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10.
Primary	PFS Per RECIST 1.1 As Assessed By Investigator in All Participants	Up to approximately 34 months	PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, PFS is reported here for all participants of the ITT population (all randomized).
Secondary	Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants	Up to approximately 34 months	ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized).
Secondary	ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	Up to approximately 34 months	ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC and who were PD-L1 CPS ≥10.
Secondary	ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC	Up to approximately 34 months	ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC.

1 to 10 of 25Source ClinicalTrials.gov

See all 25 registered outcomes

Outcomes25

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 Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10)	Up to approximately 34 months	All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 were analyzed.	Months	MEDIAN
PRIMARY	OS in Participants With ESCC	Up to approximately 34 months	All randomized participants (ITT population) with ESCC were analyzed.	Months	MEDIAN
PRIMARY	OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	Up to approximately 34 months	All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed.	Months	MEDIAN
PRIMARY	OS in All Participants	Up to approximately 34 months	All randomized participants (ITT population) were analyzed.	Months	MEDIAN
PRIMARY	Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC	Up to approximately 34 months	All randomized participants (ITT population) with ESCC were analyzed.	Months	MEDIAN
PRIMARY	PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	Up to approximately 34 months	All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed.	Months	MEDIAN
PRIMARY	PFS Per RECIST 1.1 As Assessed By Investigator in All Participants	Up to approximately 34 months	All randomized participants (ITT population) were analyzed.	Months	MEDIAN
SECONDARY	Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants	Up to approximately 34 months	All randomized participants (ITT population) were analyzed.	Percentage of Participants	NUMBER
SECONDARY	ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	Up to approximately 34 months	All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 were analyzed.	Percentage of Participants	NUMBER
SECONDARY	ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC	Up to approximately 34 months	All randomized participants (ITT population) with ESCC were analyzed.	Percentage of Participants	NUMBER

1 to 10 of 25Source ClinicalTrials.gov

See all 25 outcomes

Results by group66

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 Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10)	Pembrolizumab + SOC	13.9	95% Confidence Interval 11.1 to 17.7	Months
Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10)	Placebo + SOC	8.8	95% Confidence Interval 7.8 to 10.5	Months
OS in Participants With ESCC	Pembrolizumab + SOC	12.6	95% Confidence Interval 10.2 to 14.3	Months
OS in Participants With ESCC	Placebo + SOC	9.8	95% Confidence Interval 8.6 to 11.1	Months
OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	Pembrolizumab + SOC	13.5	95% Confidence Interval 11.1 to 15.6	Months
OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)	Placebo + SOC	9.4	95% Confidence Interval 8.0 to 10.7	Months
OS in All Participants	Pembrolizumab + SOC	12.4	95% Confidence Interval 10.5 to 14.0	Months
OS in All Participants	Placebo + SOC	9.8	95% Confidence Interval 8.8 to 10.8	Months
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC	Pembrolizumab + SOC	6.3	95% Confidence Interval 6.2 to 6.9	Months
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC	Placebo + SOC	5.8	95% Confidence Interval 5.0 to 6.1	Months

1 to 10 of 66Source ClinicalTrials.gov

See all 66 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pembrolizumab + SOC	373
Overall Study	STARTED	Placebo + SOC	376
Overall Study	Treated	Pembrolizumab + SOC	370
Overall Study	Treated	Placebo + SOC	370
Overall Study	COMPLETED	Pembrolizumab + SOC	0
Overall Study	COMPLETED	Placebo + SOC	0
Overall Study	NOT COMPLETED	Pembrolizumab + SOC	373
Overall Study	NOT COMPLETED	Placebo + SOC	376

Source ClinicalTrials.gov

Adverse events630

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	Events
other	Anaemia	Blood and lymphatic system disorders	Pembrolizumab + SOC	185	370	288
other	Anaemia	Blood and lymphatic system disorders	Placebo + SOC	199	370	295
other	Leukopenia	Blood and lymphatic system disorders	Pembrolizumab + SOC	25	370	56
other	Leukopenia	Blood and lymphatic system disorders	Placebo + SOC	29	370	72
other	Neutropenia	Blood and lymphatic system disorders	Pembrolizumab + SOC	95	370	190
other	Neutropenia	Blood and lymphatic system disorders	Placebo + SOC	90	370	179
other	Thrombocytopenia	Blood and lymphatic system disorders	Pembrolizumab + SOC	28	370	54
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo + SOC	37	370	57
other	Tinnitus	Ear and labyrinth disorders	Pembrolizumab + SOC	36	370	38
other	Tinnitus	Ear and labyrinth disorders	Placebo + SOC	27	370	30

1 to 10 of 630Source ClinicalTrials.gov

See all 630 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pembrolizumab + SOC	331	373
Total, all-cause mortality	Placebo + SOC	363	376
Total, other adverse events	Pembrolizumab + SOC	367	370
Total, other adverse events	Placebo + SOC	364	370
Total, serious adverse events	Pembrolizumab + SOC	207	370
Total, serious adverse events	Placebo + SOC	204	370

Source ClinicalTrials.gov

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30735435	DERIVED	PubMed
34454674	DERIVED	PubMed
35394255	DERIVED	PubMed
35668304	DERIVED	PubMed
37139963	DERIVED	PubMed
38607538	DERIVED	PubMed
38815152	DERIVED	PubMed
41620988	DERIVED	PubMed
42047965	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 comparisons4

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

Comparison	Source
Pembrolizumab + SOC vs Placebo + SOC: Number of Participants With an Adverse Event (AE)	Trial comparisons
Pembrolizumab + SOC vs Placebo + SOC: Number of Participants Discontinuing Study Treatment Due to an AE	Trial comparisons
Pembrolizumab + SOC vs Placebo + SOC: deaths from any cause	Trial comparisons
Pembrolizumab + SOC vs Placebo + SOC: 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/NCT03189719

GET https://conductscience.org/api/trials/v1/NCT03189719/registered?page=2

API reference For AI assistants