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NCT02358031 · FLOW

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A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048) · Source last updated 2025-07-18

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

groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
    id
    FG000
    title
    Pembrolizumab Monotherapy (Pembro Mono)
  2. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
    id
    FG001
    title
    Pembrolizumab + Chemotherapy (Pembro Combo)
  3. description
    Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
    id
    FG002
    title
    Cetuximab + Chemotherapy (Control)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        253
      2. group Id
        FG001
        num Subjects
        237
      3. group Id
        FG002
        num Subjects
        266
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        18
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        16
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        281
      3. group Id
        FG002
        num Subjects
        300
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        300
      2. group Id
        FG001
        num Subjects
        276
      3. group Id
        FG002
        num Subjects
        287
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        300
      type
      Pembro Mono v Control Efficacy Analyses
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        281
      3. group Id
        FG002
        num Subjects
        278
      type
      Pembro Combo v Control Efficacy Analyses
    5. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Received Second Course of Pembrolizumab
    6. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        299
      2. group Id
        FG001
        num Subjects
        280
      3. group Id
        FG002
        num Subjects
        300
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 1228 participants screened, 882 were randomized to the pembro mono arm, pembro combo arm, or control arm. 22 participants in the control arm that enrolled during an enrollment pause of the pembro combo arm were excluded from efficacy comparisons between the pembro combo arm and control arm. Per protocol, response/progression or adverse events (AEs) that occurred during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
recruitment Details
Participants with first line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) were recruited to examine the efficacy and safety of pembrolizumab monotherapy (pembro mono) versus pembrolizumab plus chemotherapy (pembro combo) versus cetuximab plus chemotherapy (control).
Complete source fields
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
    id
    FG000
    title
    Pembrolizumab Monotherapy (Pembro Mono)
  2. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]). Qualified participants who received the first course of pembrolizumab but continued to experience disease progression may have, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule of 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
    id
    FG001
    title
    Pembrolizumab + Chemotherapy (Pembro Combo)
  3. description
    Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
    id
    FG002
    title
    Cetuximab + Chemotherapy (Control)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        253
      2. group Id
        FG001
        num Subjects
        237
      3. group Id
        FG002
        num Subjects
        266
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        14
      3. group Id
        FG002
        num Subjects
        18
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        16
      type
      Sponsor Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        281
      3. group Id
        FG002
        num Subjects
        300
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        300
      2. group Id
        FG001
        num Subjects
        276
      3. group Id
        FG002
        num Subjects
        287
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        301
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        300
      type
      Pembro Mono v Control Efficacy Analyses
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        281
      3. group Id
        FG002
        num Subjects
        278
      type
      Pembro Combo v Control Efficacy Analyses
    5. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      Received Second Course of Pembrolizumab
    6. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    7. achievements
      1. group Id
        FG000
        num Subjects
        299
      2. group Id
        FG001
        num Subjects
        280
      3. group Id
        FG002
        num Subjects
        300
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of 1228 participants screened, 882 were randomized to the pembro mono arm, pembro combo arm, or control arm. 22 participants in the control arm that enrolled during an enrollment pause of the pembro combo arm were excluded from efficacy comparisons between the pembro combo arm and control arm. Per protocol, response/progression or adverse events (AEs) that occurred during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures, respectively.
recruitment Details
Participants with first line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) were recruited to examine the efficacy and safety of pembrolizumab monotherapy (pembro mono) versus pembrolizumab plus chemotherapy (pembro combo) versus cetuximab plus chemotherapy (control).

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