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NCT02586207 · STUDY IN CONTEXT

Pembrolizumab in Combination With CRT for LA-SCCHN

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced 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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

To determine the safety and tolerability of pembrolizumab given in combination with cisplatin-based chemoradiotherapy (CRT) in subjects with treatment naive Stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Number of participants affected by AEs will be reported by grade and percentage of participants affected. Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), laboratory tests, and vital signs. Count and percentage of AE will be provided.

Number of participants who experience an Adverse Event.

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secondary · POSTED

Response was determined using a composite end point of overall end-of-treatment (EOT) complete response (CR) at day 150 (approximately 12 weeks after completion of chemoradiotherapy) by CT of the neck (RECIST 1.1). Optional positron emission tomography (PET) imaging was allowed rather than neck dissection if CT could not confirm CR. Complete metabolic response was assessed using Hopkins score of 1, 2, or 3 on PET imaging. For those without an imaging CR, pathologic confirmation was recommend (but not required) by selective neck dissection and/or directed biopsy of the suspected active disease site. If pathologic evaluation of the potential disease site confirmed no residual invasive or in situ cancer, the patient was determined to have a pathologic CR. In cases with both an imaging CR and pathologic response assessment, the pathologic response defined final overall response. Therefore, patients with a final EOT CR included those with either an imaging (CT or PET) or pathologic CR.

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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
nct id
NCT02586207
trial label
Pembrolizumab in Combination With CRT for LA-SCCHN
applicability
unclear
applicability note
Attached because the study's own record describes locally advanced 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
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02586207
    outcome key
    om-0000
    source section id
    NCT02586207-om-0000
    source outcome index
    0
    endpoint
    Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided.
    endpoint definition
    To determine the safety and tolerability of pembrolizumab given in combination with cisplatin-based chemoradiotherapy (CRT) in subjects with treatment naive Stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Number of participants affected by AEs will be reported by grade and percentage of participants affected. Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), laboratory tests, and vital signs. Count and percentage of AE will be provided.
    time origin
    through day 240 (this time frame allows capturing of AEs that occurred up to 90 days after completion of treatment)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Number of participants who experience an Adverse Event.
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02586207
    outcome key
    om-0001
    source section id
    NCT02586207-om-0001
    source outcome index
    1
    endpoint
    Evaluation of the Efficacy of Pembrolizumab Given in Combination With Definitive CRT by Determining the Number of Participants With Complete Response at Treatment End (Day 150)
    endpoint definition
    Response was determined using a composite end point of overall end-of-treatment (EOT) complete response (CR) at day 150 (approximately 12 weeks after completion of chemoradiotherapy) by CT of the neck (RECIST 1.1). Optional positron emission tomography (PET) imaging was allowed rather than neck dissection if CT could not confirm CR. Complete metabolic response was assessed using Hopkins score of 1, 2, or 3 on PET imaging. For those without an imaging CR, pathologic confirmation was recommend (but not required) by selective neck dissection and/or directed biopsy of the suspected active disease site. If pathologic evaluation of the potential disease site confirmed no residual invasive or in situ cancer, the patient was determined to have a pathologic CR. In cases with both an imaging CR and pathologic response assessment, the pathologic response defined final overall response. Therefore, patients with a final EOT CR included those with either an imaging (CT or PET) or pathologic CR.
    time origin
    Day 150 (post treatment imaging)
    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-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02586207
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Single Arm
    regimen
    Pembrolizumab + Cisplatin + Radiation pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141. Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36 Radiation: 70 Gy fractionated over 35 days
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02586207-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02586207
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Single Arm
    regimen
    Pembrolizumab + Cisplatin + Radiation pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141. Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36 Radiation: 70 Gy fractionated over 35 days
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02586207-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-locally-advanced-d1f3aeb3
    nct id
    NCT02586207
    harm key
    EG000
    source section id
    NCT02586207-ae
    event group key
    EG000
    event group label
    Single Arm
    serious affected
    28
    serious at risk
    59
    other affected
    59
    other at risk
    59
    frequency threshold
    5
    collection period
    Enrollment through Day 150 plus 90 days for SAE reporting
    event definition
    Source null
    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