NCT02564263 · STUDY IN CONTEXT

Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After F

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

OS was defined as the time from randomization to death due to any cause. Median OS in participants with SCC of the esophagus is presented.

The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Median OS in participants with a PD-L1 CPS ≥10 is presented.

The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.

The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.

→

secondary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (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. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 in all participants is presented.

The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.

→

secondary · POSTED

ORR was defined as the percentage of participants 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) as assessed using RECIST 1.1. The percentage of all participants who experienced a CR or PR is presented.

The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.

→

secondary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (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. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with SCC of the esophagus.

The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.

→

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: NCT02564263
trial label: Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After F
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: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0000
source section id
NCT02564263-om-0000
source outcome index
0
endpoint
Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
endpoint definition
OS was defined as the time from randomization to death due to any cause. Median OS in participants with SCC of the esophagus is presented.
time origin
Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.
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
NCT02564263
outcome key
om-0001
source section id
NCT02564263-om-0001
source outcome index
1
endpoint
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)
endpoint definition
OS was defined as the time from randomization to death due to any cause. Median OS in participants with a PD-L1 CPS ≥10 is presented.
time origin
Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.
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
NCT02564263
outcome key
om-0002
source section id
NCT02564263-om-0002
source outcome index
2
endpoint
Overall Survival (OS) in All Participants
endpoint definition
OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.
time origin
Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
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
NCT02564263
outcome key
om-0003
source section id
NCT02564263-om-0003
source outcome index
3
endpoint
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
endpoint definition
PFS was defined as the time from randomization to the first documented progressive disease (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. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 in all participants is presented.
time origin
Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
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
NCT02564263
outcome key
om-0004
source section id
NCT02564263-om-0004
source outcome index
4
endpoint
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants
endpoint definition
ORR was defined as the percentage of participants 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) as assessed using RECIST 1.1. The percentage of all participants who experienced a CR or PR is presented.
time origin
Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.
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
NCT02564263
outcome key
om-0005
source section id
NCT02564263-om-0005
source outcome index
5
endpoint
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus
endpoint definition
PFS was defined as the time from randomization to the first documented progressive disease (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. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with SCC of the esophagus.
time origin
Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.
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
NCT02564263
outcome key
om-0000
arm key
OG000
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
analyzed count
198
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0000
arm key
OG001
arm label
Chemotherapy
regimen
Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
analyzed count
203
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0001
arm key
OG000
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
analyzed count
107
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0001
arm key
OG001
arm label
Chemotherapy
regimen
Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
analyzed count
115
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0002
arm key
OG000
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
analyzed count
314
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0002
arm key
OG001
arm label
Chemotherapy
regimen
Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
analyzed count
314
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0003
arm key
OG000
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
analyzed count
314
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0003
arm key
OG001
arm label
Chemotherapy
regimen
Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
analyzed count
314
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0004
arm key
OG000
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
analyzed count
314
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0004
arm key
OG001
arm label
Chemotherapy
regimen
Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
analyzed count
314
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0005
arm key
OG000
arm label
Pembrolizumab
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
analyzed count
198
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
outcome key
om-0005
arm key
OG001
arm label
Chemotherapy
regimen
Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
analyzed count
203
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02564263-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02564263
harm key
EG000
source section id
NCT02564263-ae
event group key
EG000
event group label
Pembrolizumab First Course
serious affected
127
serious at risk
314
other affected
285
other at risk
314
frequency threshold
5
collection period
Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years)
event definition
All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated 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
NCT02564263
harm key
EG001
source section id
NCT02564263-ae
event group key
EG001
event group label
Chemotherapy
serious affected
121
serious at risk
296
other affected
281
other at risk
296
frequency threshold
5
collection period
Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years)
event definition
All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated 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
NCT02564263
harm key
EG002
source section id
NCT02564263-ae
event group key
EG002
event group label
Pembrolizumab Second Course
serious affected
1
serious at risk
5
other affected
5
other at risk
5
frequency threshold
5
collection period
Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years)
event definition
All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated 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