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NCT06099782 · OUTCOME

Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3

A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11) · Source last updated 2026-04-08

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Day 106

What was measured

The PPQ is an instrument that has been developed from patient interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. PPQ Question 3 evaluated 2 main reasons for participants' preference for one of the administration methods (SC or IV), with response options including "feels less emotionally distressing", "requires less time in the clinic", and "lower level injection-site pain". As pre-specified by the supplemental statistical analysis plan (sSAP), the most frequent reasons for preferring SC administration as assessed by PPQ Question 3 were reported among all participants preferring SC in each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.

Analysis population: The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, subsequently answered question 3 of the PPQ on Day 106, and preferred SC administration.

Groups in this outcome

Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV

In the Treatment Crossover Period participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles.

Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC

In the Treatment Crossover Period participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles.

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

Analysis denominator · Participants

GroupSource count
Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV32
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC45

Reported measurements

Requires less time in the clinic
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV59.4Not reportedNot reportedNot reportedNot reported
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC66.7Not reportedNot reportedNot reportedNot reported
Feels more comfortable during administration
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV68.8Not reportedNot reportedNot reportedNot reported
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC57.8Not reportedNot reportedNot reportedNot reported
Lower level of injection-site pain
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV31.3Not reportedNot reportedNot reportedNot reported
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC42.2Not reportedNot reportedNot reportedNot reported
Feels less emotionally distressing
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV21.9Not reportedNot reportedNot reportedNot reported
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC20.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        59.4
      2. group Id
        OG001
        value
        66.7
    title
    Requires less time in the clinic
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        68.8
      2. group Id
        OG001
        value
        57.8
    title
    Feels more comfortable during administration
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        31.3
      2. group Id
        OG001
        value
        42.2
    title
    Lower level of injection-site pain
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        21.9
      2. group Id
        OG001
        value
        20.0
    title
    Feels less emotionally distressing
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      45
    units
    Participants
description
The PPQ is an instrument that has been developed from patient interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. PPQ Question 3 evaluated 2 main reasons for participants' preference for one of the administration methods (SC or IV), with response options including "feels less emotionally distressing", "requires less time in the clinic", and "lower level injection-site pain". As pre-specified by the supplemental statistical analysis plan (sSAP), the most frequent reasons for preferring SC administration as assessed by PPQ Question 3 were reported among all participants preferring SC in each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.
groups
  1. description
    In the Treatment Crossover Period participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles.
    id
    OG000
    title
    Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV
  2. description
    In the Treatment Crossover Period participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles.
    id
    OG001
    title
    Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
param Type
NUMBER
population Description
The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, subsequently answered question 3 of the PPQ on Day 106, and preferred SC administration.
reporting Status
POSTED
time Frame
Day 106
title
Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3
type
SECONDARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice