NCT02559687 · STUDY IN CONTEXT

Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180)

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 was reported per protocol for the first course of treatment.

All allocated participants who received at least 1 dose of study treatment.

→

secondary · POSTED

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who experienced ≥1 AE was reported per protocol for the first course of treatment.

All allocated participants who received at least 1 dose of study treatment.

→

secondary · POSTED

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants that discontinued study treatment due to an AE was reported per protocol for the first course of treatment.

All allocated participants who received at least 1 dose of study treatment.

→

secondary · POSTED

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. 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 must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported per protocol for the first course of treatment.

All allocated participants who received at least 1 dose of study treatment and who experienced a confirmed CR or confirmed PR. One previously reported participant was excluded from the DOR analysis based on a BICR re-read of prior scans after the primary analysis database lock.

→

secondary · POSTED

PFS was defined as the time from first day of study treatment to the first documented PD 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 must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 was reported per protocol for the first course of treatment.

All allocated participants who received at least 1 dose of study treatment.

→

secondary · POSTED

OS was defined as the time from first day of study treatment 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. OS was reported per protocol for the first course of treatment

All allocated participants who received at least 1 dose of study treatment.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-gastroesophageal-junction-carcinoma
nct id: NCT02559687
trial label: Study of Pembrolizumab (MK-3475) in Previously-Treated Participants With Advanced Carcinoma of the Esophagus or Esophagogastric Junction (MK-3475-180/KEYNOTE-180)
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0000
source section id
NCT02559687-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)
endpoint definition
ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 was reported per protocol for the first course of treatment.
time origin
Up to approximately 28 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0001
source section id
NCT02559687-om-0001
source outcome index
1
endpoint
Number of Participants Who Experienced an Adverse Event (AE)
endpoint definition
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who experienced ≥1 AE was reported per protocol for the first course of treatment.
time origin
Up to approximately 59 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0002
source section id
NCT02559687-om-0002
source outcome index
2
endpoint
Number of Participants That Discontinued Study Treatment Due to an AE
endpoint definition
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants that discontinued study treatment due to an AE was reported per protocol for the first course of treatment.
time origin
Up to approximately 24 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0003
source section id
NCT02559687-om-0003
source outcome index
3
endpoint
Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR
endpoint definition
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. 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 must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported per protocol for the first course of treatment.
time origin
Up to approximately 67 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study treatment and who experienced a confirmed CR or confirmed PR. One previously reported participant was excluded from the DOR analysis based on a BICR re-read of prior scans after the primary analysis database lock.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0004
source section id
NCT02559687-om-0004
source outcome index
4
endpoint
Progression Free Survival (PFS) According to RECIST 1.1 Assessed by BICR
endpoint definition
PFS was defined as the time from first day of study treatment to the first documented PD 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 must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 was reported per protocol for the first course of treatment.
time origin
Up to approximately 67 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0005
source section id
NCT02559687-om-0005
source outcome index
5
endpoint
Overall Survival (OS)
endpoint definition
OS was defined as the time from first day of study treatment 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. OS was reported per protocol for the first course of treatment
time origin
Up to approximately 67 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All allocated participants who received at least 1 dose of study treatment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0000
arm key
OG000
arm label
Pembrolizumab 200 mg
regimen
Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
analyzed count
121
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02559687-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0001
arm key
OG000
arm label
Pembrolizumab 200 mg
regimen
Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
analyzed count
121
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02559687-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0002
arm key
OG000
arm label
Pembrolizumab 200 mg
regimen
Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
analyzed count
121
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02559687-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0003
arm key
OG000
arm label
Pembrolizumab 200 mg
regimen
Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02559687-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0004
arm key
OG000
arm label
Pembrolizumab 200 mg
regimen
Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
analyzed count
121
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02559687-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
outcome key
om-0005
arm key
OG000
arm label
Pembrolizumab 200 mg
regimen
Participants receive pembrolizumab 200 mg IV Q3W for up to 35 treatments (approximately 2 years).
analyzed count
121
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02559687-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
harm key
EG000
source section id
NCT02559687-ae
event group key
EG000
event group label
Pembrolizumab 200 mg First Course
serious affected
47
serious at risk
121
other affected
107
other at risk
121
frequency threshold
5
collection period
Up to approximately 67 months
event definition
All-Cause Mortality was reported for all allocated participants. Serious AEs and Other AEs were reported for all allocated participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02559687
harm key
EG001
source section id
NCT02559687-ae
event group key
EG001
event group label
Pembrolizumab 200 mg Second Course
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
Up to approximately 67 months
event definition
All-Cause Mortality was reported for all allocated participants. Serious AEs and Other AEs were reported for all allocated participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice