NCT02569242 · STUDY IN CONTEXT

Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Overall Survival

Source null

→

secondary · POSTED

Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."

Source null

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secondary · POSTED

Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."

Source null

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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-esophageal-cancer-recurrent-2b28610b
nct id: NCT02569242
trial label: Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 3
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
outcome key
om-0000
source section id
NCT02569242-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
Overall Survival
time origin
("Date of death from any cause" - "Date of randomization" + 1) / 30.4375. For subjects lost to follow-up and subjects who are alive at the time of data cutoff date, data will be censored at the time the subject was last confirmed to be alive.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
outcome key
om-0001
source section id
NCT02569242-om-0001
source outcome index
1
endpoint
Progression-free Survival
endpoint definition
Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."
time origin
("Earlier date on which either the overall response was assessed as PD or the subject died of any cause" - "Date of randomization" + 1) / 30.4375.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
outcome key
om-0002
source section id
NCT02569242-om-0002
source outcome index
2
endpoint
Duration of Response
endpoint definition
Please refer to the protocol, overall response and best overall response will be determined solely by imaging assessment according to the RECIST Guideline Version 1.1, and will not take into account any clinical/symptomatic progression. Evaluable imaging data will be overall response without an overall response of "Not Evaluable (NE)."
time origin
("Earlier date on which either the overall response was assessed as PD for the first time after confirmed response or the subject died of any cause" - "Date of first assessment of confirmed CR or PR" + 1) / 30.4375.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
outcome key
om-0000
arm key
OG000
arm label
Nivolumab Arm
regimen
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02569242-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
outcome key
om-0000
arm key
OG001
arm label
Active Comparator Arm （Docetaxel/Paclitaxel）
regimen
Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
209
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02569242-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
outcome key
om-0001
arm key
OG000
arm label
Nivolumab Arm
regimen
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02569242-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
outcome key
om-0001
arm key
OG001
arm label
Active Comparator Arm （Docetaxel/Paclitaxel）
regimen
Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
209
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02569242-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
outcome key
om-0002
arm key
OG000
arm label
Nivolumab Arm
regimen
Nivolumab 240 mg/body solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
210
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02569242-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
outcome key
om-0002
arm key
OG001
arm label
Active Comparator Arm （Docetaxel/Paclitaxel）
regimen
Docetaxel: Intravenously administered at a dose of 75 mg/m2 every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends OR Paclitaxel: Intravenously administered at a dose of 100 mg/m2 weekly for 6 weeks followed by 2-week drug holiday until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
analyzed count
209
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02569242-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
harm key
EG000
source section id
NCT02569242-ae
event group key
EG000
event group label
Nivolumab Arm
serious affected
68
serious at risk
209
other affected
185
other at risk
209
frequency threshold
5
collection period
Monitoring for any AEs will be continued until 28 days after the end of the treatment phase. In subjects who, at the time of initiation of the follow-up investigation, have any AE for which a causal relationship to the investigational product cannot be ruled out or which led to discontinuation, investigation of the AE will be continued until the event is judged not to require further follow-up. SAEs are to be collected during the treatment period and for 100 days following the last dose.
event definition
For all-cause mortality, the number of adverse events reported as Grade 5 was extracted.
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-esophageal-cancer-recurrent-2b28610b
nct id
NCT02569242
harm key
EG001
source section id
NCT02569242-ae
event group key
EG001
event group label
Active Comparator Arm （Docetaxel/Paclitaxel）
serious affected
77
serious at risk
208
other affected
204
other at risk
208
frequency threshold
5
collection period
Monitoring for any AEs will be continued until 28 days after the end of the treatment phase. In subjects who, at the time of initiation of the follow-up investigation, have any AE for which a causal relationship to the investigational product cannot be ruled out or which led to discontinuation, investigation of the AE will be continued until the event is judged not to require further follow-up. SAEs are to be collected during the treatment period and for 100 days following the last dose.
event definition
For all-cause mortality, the number of adverse events reported as Grade 5 was extracted.
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