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NCT03698019 · STUDY IN CONTEXT

A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma

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

Event-free survival (EFS) is measured from date of randomization to date of first: documentation of progression that render participant unable to receive planned protocol surgery, off protocol therapy for any reason without subsequent protocol surgery, failure to begin adjuvant therapy within 84 days after surgery, relapse after surgery or death due to any cause. Participants last known to be alive and event-free are censored at date of last contact. All events that occurred before the start of adjuvant therapy were assigned an event date of 84 days.

Source null

→

secondary · POSTED

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Eligible participants that received protocol treatment

→

secondary · POSTED

Overall survival (OS) is measured from date of randomization to date of death due to any cause. Participants known to be alive are censored at date of last contact.

Source null

→

secondary · NOT_POSTED

On the neoadjuvant arm, the response rate was assessed after neoadjuvant therapy and before surgical resection. The response rate includes both complete response (CR) and partial response (PR). CR is defined as complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. PR is defined as greater than or equal to 30% decrease under baseline of the sum of all appropriate diameters of all target measurable lesions, no unequivocal progression or non-measurable disease, and no new lesions. The best response rate is calculated from the sequence of objective statuses. CR is defined as two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. PR is defined as two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR.

Source null

→

secondary · POSTED

To determine the number of participants on each arm who received the surgery planned at randomization.

Source null

→

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-skin-cancer
nct id
NCT03698019
trial label
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
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
5
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0000
    source section id
    NCT03698019-om-0000
    source outcome index
    0
    endpoint
    Two-Year Event-Free Survival Rate
    endpoint definition
    Event-free survival (EFS) is measured from date of randomization to date of first: documentation of progression that render participant unable to receive planned protocol surgery, off protocol therapy for any reason without subsequent protocol surgery, failure to begin adjuvant therapy within 84 days after surgery, relapse after surgery or death due to any cause. Participants last known to be alive and event-free are censored at date of last contact. All events that occurred before the start of adjuvant therapy were assigned an event date of 84 days.
    time origin
    2 years
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0001
    source section id
    NCT03698019-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
    endpoint definition
    Only adverse events that are possibly, probably or definitely related to study drug are reported.
    time origin
    Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible participants that received protocol treatment
    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-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0002
    source section id
    NCT03698019-om-0002
    source outcome index
    2
    endpoint
    Two-Year Overall Survival Rate
    endpoint definition
    Overall survival (OS) is measured from date of randomization to date of death due to any cause. Participants known to be alive are censored at date of last contact.
    time origin
    2 years
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0003
    source section id
    NCT03698019-om-0003
    source outcome index
    3
    endpoint
    Response Rate
    endpoint definition
    On the neoadjuvant arm, the response rate was assessed after neoadjuvant therapy and before surgical resection. The response rate includes both complete response (CR) and partial response (PR). CR is defined as complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. PR is defined as greater than or equal to 30% decrease under baseline of the sum of all appropriate diameters of all target measurable lesions, no unequivocal progression or non-measurable disease, and no new lesions. The best response rate is calculated from the sequence of objective statuses. CR is defined as two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. PR is defined as two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR.
    time origin
    2 years
    analysis role
    secondary
    reporting status
    NOT_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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0004
    source section id
    NCT03698019-om-0004
    source outcome index
    4
    endpoint
    Number of Participants Receiving Surgery
    endpoint definition
    To determine the number of participants on each arm who received the surgery planned at randomization.
    time origin
    2.5 years
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (Adjuvant Pembrolizumab)
    regimen
    Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    analyzed count
    159
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03698019-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    analyzed count
    154
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03698019-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (Adjuvant Pembrolizumab)
    regimen
    Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    analyzed count
    141
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03698019-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    analyzed count
    152
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03698019-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (Adjuvant Pembrolizumab)
    regimen
    Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    analyzed count
    159
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03698019-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    analyzed count
    154
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03698019-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm I (Adjuvant Pembrolizumab)
    regimen
    Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    analyzed count
    159
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03698019-om-0004#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
    regimen
    Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    analyzed count
    154
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03698019-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-skin-cancer
    nct id
    NCT03698019
    harm key
    EG000
    source section id
    NCT03698019-ae
    event group key
    EG000
    event group label
    Arm I (Adjuvant Pembrolizumab)
    serious affected
    33
    serious at risk
    141
    other affected
    132
    other at risk
    141
    frequency threshold
    5
    collection period
    Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization
    event definition
    AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
    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-skin-cancer
    nct id
    NCT03698019
    harm key
    EG001
    source section id
    NCT03698019-ae
    event group key
    EG001
    event group label
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
    serious affected
    34
    serious at risk
    152
    other affected
    148
    other at risk
    152
    frequency threshold
    5
    collection period
    Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization
    event definition
    AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
    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