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← Melanoma

NCT01704287 · STUDY IN CONTEXT

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

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

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 Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was 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 have also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS.

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

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.

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

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for OS.

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

→

secondary · POSTED

OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented.

The analysis population consisted of all randomized participants who had a PD-L1 tumor expression status assessment. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.

→

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: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.

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

→

secondary · POSTED

BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.

The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy 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-melanoma
nct id
NCT01704287
trial label
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)
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
7
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0000
    source section id
    NCT01704287-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS) - Initial Treatment Period
    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 Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was 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 have also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS.
    time origin
    Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for 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-melanoma
    nct id
    NCT01704287
    outcome key
    om-0001
    source section id
    NCT01704287-om-0001
    source outcome index
    1
    endpoint
    Interim Overall Survival (OS) - Initial Treatment Period
    endpoint definition
    OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.
    time origin
    Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for 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-melanoma
    nct id
    NCT01704287
    outcome key
    om-0002
    source section id
    NCT01704287-om-0002
    source outcome index
    2
    endpoint
    Final Overall Survival (OS) - Initial Treatment Period
    endpoint definition
    OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for OS.
    time origin
    Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for 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-melanoma
    nct id
    NCT01704287
    outcome key
    om-0003
    source section id
    NCT01704287-om-0003
    source outcome index
    3
    endpoint
    Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period
    endpoint definition
    OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented.
    time origin
    Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants who had a PD-L1 tumor expression status assessment. Participants were included in the initial treatment group to which they were randomized for 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-melanoma
    nct id
    NCT01704287
    outcome key
    om-0004
    source section id
    NCT01704287-om-0004
    source outcome index
    4
    endpoint
    Overall Response Rate (ORR) - Initial Treatment Period
    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: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.
    time origin
    Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy 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-melanoma
    nct id
    NCT01704287
    outcome key
    om-0005
    source section id
    NCT01704287-om-0005
    source outcome index
    5
    endpoint
    Best Overall Response (BOR) - Initial Treatment Period
    endpoint definition
    BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.
    time origin
    Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy 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-melanoma
    nct id
    NCT01704287
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pembrolizumab 2 mg/kg
    regimen
    Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    180
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Pembrolizumab 10 mg/kg
    regimen
    Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    181
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Investigator-Choice Chemotherapy (ICC)
    regimen
    Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    179
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pembrolizumab 2 mg/kg
    regimen
    Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    180
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Pembrolizumab 10 mg/kg
    regimen
    Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    181
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Investigator-Choice Chemotherapy (ICC)
    regimen
    Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    179
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pembrolizumab 2 mg/kg
    regimen
    Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    180
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Pembrolizumab 10 mg/kg
    regimen
    Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    181
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Investigator-Choice Chemotherapy (ICC)
    regimen
    Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    179
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pembrolizumab 2 mg/kg
    regimen
    Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    180
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Pembrolizumab 10 mg/kg
    regimen
    Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    181
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Investigator-Choice Chemotherapy (ICC)
    regimen
    Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    analyzed count
    179
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01704287-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    harm key
    EG000
    source section id
    NCT01704287-ae
    event group key
    EG000
    event group label
    Investigator-Choice Chemotherapy (ICC) Only
    serious affected
    33
    serious at risk
    73
    other affected
    66
    other at risk
    73
    frequency threshold
    5
    collection period
    Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
    event definition
    Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    harm key
    EG001
    source section id
    NCT01704287-ae
    event group key
    EG001
    event group label
    ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab)
    serious affected
    15
    serious at risk
    53
    other affected
    52
    other at risk
    53
    frequency threshold
    5
    collection period
    Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
    event definition
    Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    harm key
    EG002
    source section id
    NCT01704287-ae
    event group key
    EG002
    event group label
    ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab)
    serious affected
    9
    serious at risk
    45
    other affected
    44
    other at risk
    45
    frequency threshold
    5
    collection period
    Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
    event definition
    Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    harm key
    EG003
    source section id
    NCT01704287-ae
    event group key
    EG003
    event group label
    Pembrolizumab 2 mg/kg
    serious affected
    91
    serious at risk
    178
    other affected
    158
    other at risk
    178
    frequency threshold
    5
    collection period
    Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
    event definition
    Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    harm key
    EG004
    source section id
    NCT01704287-ae
    event group key
    EG004
    event group label
    Pembrolizumab 10 mg/kg
    serious affected
    78
    serious at risk
    179
    other affected
    176
    other at risk
    179
    frequency threshold
    5
    collection period
    Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
    event definition
    Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    harm key
    EG005
    source section id
    NCT01704287-ae
    event group key
    EG005
    event group label
    ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)
    serious affected
    18
    serious at risk
    53
    other affected
    48
    other at risk
    53
    frequency threshold
    5
    collection period
    Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
    event definition
    Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (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
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-melanoma
    nct id
    NCT01704287
    harm key
    EG006
    source section id
    NCT01704287-ae
    event group key
    EG006
    event group label
    ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)
    serious affected
    18
    serious at risk
    45
    other affected
    36
    other at risk
    45
    frequency threshold
    5
    collection period
    Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
    event definition
    Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (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