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NCT04576091 · OUTCOME

Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score

Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer · Source last updated 2026-08-21

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
At 3 months from start of treatment

What was measured

The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.

Analysis population: Enrolled patients who complete assessment at indicated timepoint.

Groups in this outcome

Treatment (Pembrolizumab, BAY 1895344, SBRT)

Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT

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

Analysis denominator · Participants

GroupSource count
Treatment (Pembrolizumab, BAY 1895344, SBRT)6

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)87.431.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.6
        value
        87.4
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
The FACT-H\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.
dispersion Type
Standard Deviation
groups
  1. description
    Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: Undergo SBRT
    id
    OG000
    title
    Treatment (Pembrolizumab, BAY 1895344, SBRT)
param Type
MEAN
population Description
Enrolled patients who complete assessment at indicated timepoint.
reporting Status
POSTED
time Frame
At 3 months from start of treatment
title
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
type
SECONDARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Independent clinical review pending · Not medical advice