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NCT04576091 · OUTCOME

2-year Progression-free Survival

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
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
At 2 years

What was measured

Percentage of patients alive without disease progression at 2 years. Per RECIST 1.1, Disease Progression is defined as ≥20%increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Analysis population: Treated patients who were radiologically evaluable.

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 percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)17Not reported152Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        52
        value
        17
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Percentage of patients alive without disease progression at 2 years. Per RECIST 1.1, Disease Progression is defined as ≥20%increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
Treated patients who were radiologically evaluable.
reporting Status
POSTED
time Frame
At 2 years
title
2-year Progression-free Survival
type
SECONDARY
unit Of Measure
percentage of patients

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

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