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← Gastroesophageal Junction Carcinoma

NCT03615326 · STUDY IN CONTEXT

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarci

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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PFS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

→

primary · POSTED

OS is defined as the time from randomization to death due to any cause. OS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

→

secondary · POSTED

ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by blinded independent central review (BICR). ORR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

→

secondary · POSTED

For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm and who had CR or PR per RECIST 1.1 as assessed by BICR were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.

→

secondary · POSTED

An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.

All randomized participants in the Global Cohort Pembrolizumab and SOC arms who received at least 1 dose of treatment, and all participants in the Japan-specific SOX Cohort who received at least 1 dose of treatment were included in this analysis. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.

→

secondary · POSTED

An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study treatment due to an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.

All randomized participants in the Global Cohort Pembrolizumab and SOC arms who received at least 1 dose of treatment, and all participants in the Japan-specific SOX Cohort who received at least 1 dose of treatment were included in this analysis. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.

→

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
NCT03615326
trial label
Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarci
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
5
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0000
    source section id
    NCT03615326-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR
    endpoint definition
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. PFS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
    time origin
    Up to 46 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0001
    source section id
    NCT03615326-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS is defined as the time from randomization to death due to any cause. OS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
    time origin
    Up to 63 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0002
    source section id
    NCT03615326-om-0002
    source outcome index
    2
    endpoint
    Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICR
    endpoint definition
    ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by blinded independent central review (BICR). ORR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
    time origin
    Up to 63 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0003
    source section id
    NCT03615326-om-0003
    source outcome index
    3
    endpoint
    Duration of Response (DOR) Per RECIST 1.1 Assessed by BICR
    endpoint definition
    For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
    time origin
    Up to 63 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm and who had CR or PR per RECIST 1.1 as assessed by BICR were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0004
    source section id
    NCT03615326-om-0004
    source outcome index
    4
    endpoint
    Number of Participants Who Experienced an Adverse Event (AE)
    endpoint definition
    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
    time origin
    Up to 63 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants in the Global Cohort Pembrolizumab and SOC arms who received at least 1 dose of treatment, and all participants in the Japan-specific SOX Cohort who received at least 1 dose of treatment were included in this analysis. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0005
    source section id
    NCT03615326-om-0005
    source outcome index
    5
    endpoint
    Number of Participants Who Discontinued Study Treatment Due to AEs
    endpoint definition
    An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued study treatment due to an AE is reported for each treatment arm. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
    time origin
    Up to 63 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants in the Global Cohort Pembrolizumab and SOC arms who received at least 1 dose of treatment, and all participants in the Japan-specific SOX Cohort who received at least 1 dose of treatment were included in this analysis. Per statistical analysis plan, data from the second course of pembrolizumab was not included in the safety analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Global Pembrolizumab + Standard of Care First Course
    regimen
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Global Standard of Care
    regimen
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    348
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Global Pembrolizumab + Standard of Care First Course
    regimen
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Global Standard of Care First Course
    regimen
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    348
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Global Pembrolizumab + Standard of Care First Course
    regimen
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Global Standard of Care First Course
    regimen
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    348
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Global Pembrolizumab + Standard of Care First Course
    regimen
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    254
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Global Standard of Care First Course
    regimen
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    209
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Global Pembrolizumab + Standard of Care First Course
    regimen
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    350
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Global Standard of Care First Course
    regimen
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    analyzed count
    346
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0004
    arm key
    OG002
    arm label
    Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
    regimen
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0004#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    outcome key
    om-0004
    arm key
    OG003
    arm label
    Japan Trastuzumab + S-1 Plus Oxaliplatin
    regimen
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03615326-om-0004#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    harm key
    EG000
    source section id
    NCT03615326-ae
    event group key
    EG000
    event group label
    Global Pembrolizumab + Standard of Care First Course
    serious affected
    163
    serious at risk
    350
    other affected
    345
    other at risk
    350
    frequency threshold
    5
    collection period
    Up to 63 months
    event definition
    All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    harm key
    EG001
    source section id
    NCT03615326-ae
    event group key
    EG001
    event group label
    Global Standard of Care
    serious affected
    159
    serious at risk
    346
    other affected
    338
    other at risk
    346
    frequency threshold
    5
    collection period
    Up to 63 months
    event definition
    All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    harm key
    EG002
    source section id
    NCT03615326-ae
    event group key
    EG002
    event group label
    Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
    serious affected
    10
    serious at risk
    20
    other affected
    20
    other at risk
    20
    frequency threshold
    5
    collection period
    Up to 63 months
    event definition
    All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    harm key
    EG003
    source section id
    NCT03615326-ae
    event group key
    EG003
    event group label
    Japan Trastuzumab + S-1 Plus Oxaliplatin
    serious affected
    9
    serious at risk
    20
    other affected
    20
    other at risk
    20
    frequency threshold
    5
    collection period
    Up to 63 months
    event definition
    All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastroesophageal-junction-carcinoma
    nct id
    NCT03615326
    harm key
    EG004
    source section id
    NCT03615326-ae
    event group key
    EG004
    event group label
    Global Pembrolizumab + Standard of Care Second Course
    serious affected
    0
    serious at risk
    11
    other affected
    9
    other at risk
    11
    frequency threshold
    5
    collection period
    Up to 63 months
    event definition
    All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
    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