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NCT03765918 · OUTCOME

Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 25

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.

Measure
LEAST_SQUARES_MEAN
Unit
Score on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline and Week 25

What was measured

EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.

Analysis population: All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.

Groups in this outcome

Pembrolizumab + Standard of Care (SOC)

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).

Standard of Care (SOC)

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).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Pembrolizumab + Standard of Care (SOC)340
Standard of Care (SOC)291

Reported measurements

Source class 1
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + Standard of Care (SOC)4.20Not reported0.597.82Not reported
Standard of Care (SOC)6.72Not reported3.0010.45Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -7.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.35
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.
    non Inferiority Type
    OTHER
    p Value
    0.3103
    p Value Comment
    Two-sided p-value based on cLDA model.
    param Type
    Difference in Least Square Means
    param Value
    -2.52
    statistical Method
    cLDA model
Complete source fields
analyses
  1. ci Lower Limit
    -7.39
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.35
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.
    non Inferiority Type
    OTHER
    p Value
    0.3103
    p Value Comment
    Two-sided p-value based on cLDA model.
    param Type
    Difference in Least Square Means
    param Value
    -2.52
    statistical Method
    cLDA model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.59
        upper Limit
        7.82
        value
        4.20
      2. group Id
        OG001
        lower Limit
        3.00
        upper Limit
        10.45
        value
        6.72
denoms
  1. counts
    1. group Id
      OG000
      value
      340
    2. group Id
      OG001
      value
      291
    units
    Participants
description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Standard of Care (SOC)
param Type
LEAST_SQUARES_MEAN
population Description
All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H\&N35 assessment data available for this outcome measure at Baseline and at Week 25.
reporting Status
POSTED
time Frame
Baseline and Week 25
title
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
type
SECONDARY
unit Of Measure
Score on a scale

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Preserved source evidence · Not medical advice