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NCT03765918 · FLOW

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Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689) · Source last updated 2026-07-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
    id
    FG000
    title
    Pembrolizumab + Standard of Care (SOC)
  2. description
    Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
    id
    FG001
    title
    Standard of Care (SOC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        127
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        240
      2. group Id
        FG001
        num Subjects
        205
      type
      Participants Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        363
      2. group Id
        FG001
        num Subjects
        351
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        360
      2. group Id
        FG001
        num Subjects
        316
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        361
      2. group Id
        FG001
        num Subjects
        315
      comment
      All participants who received ≥1 dose of study treatment: 1 participant in the SOC arm received neoadjuvant treatment, which was a protocol deviation, and this participant was continued in the Pembrolizumab + SOC arm in the study.
      type
      Safety Analysis Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        363
      2. group Id
        FG001
        num Subjects
        351
      comment
      All randomized participants: 2 participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.
      type
      Efficacy Analysis Population
    5. achievements
      1. group Id
        FG000
        num Subjects
        354
      2. group Id
        FG001
        num Subjects
        0
      type
      Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 & 30) Assessment
    6. achievements
      1. group Id
        FG000
        num Subjects
        356
      2. group Id
        FG001
        num Subjects
        306
      type
      Adjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 and 30) Assessment
    7. achievements
      1. group Id
        FG000
        num Subjects
        354
      2. group Id
        FG001
        num Subjects
        0
      type
      Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 (Items 1-5) Assessment
    8. achievements
      1. group Id
        FG000
        num Subjects
        356
      2. group Id
        FG001
        num Subjects
        306
      type
      Adjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 (Items 1-5) Assessment
    9. achievements
      1. group Id
        FG000
        num Subjects
        354
      2. group Id
        FG001
        num Subjects
        0
      type
      Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 35-38) Assessment
    10. achievements
      1. group Id
        FG000
        num Subjects
        356
      2. group Id
        FG001
        num Subjects
        306
      type
      Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 35-38) Assessment
    11. achievements
      1. group Id
        FG000
        num Subjects
        354
      2. group Id
        FG001
        num Subjects
        0
      type
      Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 46, 53-54) Assessment
    12. achievements
      1. group Id
        FG000
        num Subjects
        356
      2. group Id
        FG001
        num Subjects
        306
      type
      Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 46, 53-54) Assessment
    title
    Overall Study
pre Assignment Details
Two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations). One of the participants (who received one cycle of neoadjuvant treatment) was included in the SOC arm for the efficacy and safety analyses per protocol. The other participant (who received 2 cycles of neoadjuvant treatment) was included in the SOC arm for efficacy analysis and in the Pembrolizumab + SOC arm for the safety analysis per protocol.
recruitment Details
Per protocol, patient-reported outcome (PRO) measures (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 \[EORTC QLQ-C30\] Global Health Status \[GHS\]/Quality of Life \[QoL\]\[Items 29 and 30\], EORTC QLQ-C30 \[Items 1-5\], EORTC QLQ-Head and Neck Module 35 \[H\&N35\] \[Items 35-38\], EORTC QLQ-H\&N35 \[Items 46, 53-54\], and EORTC QLQ-H\&N35 \[Items 31-34\] were reported separately for neoadjuvant and adjuvant treatment periods.
Complete source fields
groups
  1. description
    Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
    id
    FG000
    title
    Pembrolizumab + Standard of Care (SOC)
  2. description
    Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
    id
    FG001
    title
    Standard of Care (SOC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        127
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        240
      2. group Id
        FG001
        num Subjects
        205
      type
      Participants Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        363
      2. group Id
        FG001
        num Subjects
        351
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        360
      2. group Id
        FG001
        num Subjects
        316
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        361
      2. group Id
        FG001
        num Subjects
        315
      comment
      All participants who received ≥1 dose of study treatment: 1 participant in the SOC arm received neoadjuvant treatment, which was a protocol deviation, and this participant was continued in the Pembrolizumab + SOC arm in the study.
      type
      Safety Analysis Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        363
      2. group Id
        FG001
        num Subjects
        351
      comment
      All randomized participants: 2 participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.
      type
      Efficacy Analysis Population
    5. achievements
      1. group Id
        FG000
        num Subjects
        354
      2. group Id
        FG001
        num Subjects
        0
      type
      Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 & 30) Assessment
    6. achievements
      1. group Id
        FG000
        num Subjects
        356
      2. group Id
        FG001
        num Subjects
        306
      type
      Adjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 GHS/QoL (Items 29 and 30) Assessment
    7. achievements
      1. group Id
        FG000
        num Subjects
        354
      2. group Id
        FG001
        num Subjects
        0
      type
      Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 (Items 1-5) Assessment
    8. achievements
      1. group Id
        FG000
        num Subjects
        356
      2. group Id
        FG001
        num Subjects
        306
      type
      Adjuvant Treatment Period: Participants Who Took EORTCQLQ-C30 (Items 1-5) Assessment
    9. achievements
      1. group Id
        FG000
        num Subjects
        354
      2. group Id
        FG001
        num Subjects
        0
      type
      Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 35-38) Assessment
    10. achievements
      1. group Id
        FG000
        num Subjects
        356
      2. group Id
        FG001
        num Subjects
        306
      type
      Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 35-38) Assessment
    11. achievements
      1. group Id
        FG000
        num Subjects
        354
      2. group Id
        FG001
        num Subjects
        0
      type
      Neoadjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 46, 53-54) Assessment
    12. achievements
      1. group Id
        FG000
        num Subjects
        356
      2. group Id
        FG001
        num Subjects
        306
      type
      Adjuvant Treatment Period: Participants Who Took EORTCQLQ-H&N35 (Items 46, 53-54) Assessment
    title
    Overall Study
pre Assignment Details
Two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations). One of the participants (who received one cycle of neoadjuvant treatment) was included in the SOC arm for the efficacy and safety analyses per protocol. The other participant (who received 2 cycles of neoadjuvant treatment) was included in the SOC arm for efficacy analysis and in the Pembrolizumab + SOC arm for the safety analysis per protocol.
recruitment Details
Per protocol, patient-reported outcome (PRO) measures (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 \[EORTC QLQ-C30\] Global Health Status \[GHS\]/Quality of Life \[QoL\]\[Items 29 and 30\], EORTC QLQ-C30 \[Items 1-5\], EORTC QLQ-Head and Neck Module 35 \[H\&N35\] \[Items 35-38\], EORTC QLQ-H\&N35 \[Items 46, 53-54\], and EORTC QLQ-H\&N35 \[Items 31-34\] were reported separately for neoadjuvant and adjuvant treatment periods.

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