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NCT04576091 · OUTCOME

Incidence of Adverse Events

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 12 months

What was measured

Number of patients that experienced AEs and/or SAEs per CTCAE version 5 at least possibly related to treatment.

Analysis population: All treated patients

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

Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)2Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)2Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)2Not reportedNot reportedNot reportedNot reported
Mucositis oral
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)2Not reportedNot reportedNot reportedNot reported
White blood cell decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)2Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)1Not reportedNot reportedNot reportedNot reported
Hot flashes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)1Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)1Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)1Not reportedNot reportedNot reportedNot reported
Salivary duct inflammation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)1Not reportedNot reportedNot reportedNot reported
Xerostomia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)1Not reportedNot reportedNot reportedNot reported
Flushing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Diarrhea
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Lymphocyte count decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Mucositis oral
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    White blood cell decreased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Fatigue
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hot flashes
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypotension
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Neutrophil count decreased
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Salivary duct inflammation
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Xerostomia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Flushing
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Number of patients that experienced AEs and/or SAEs per CTCAE version 5 at least possibly related to treatment.
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
COUNT_OF_PARTICIPANTS
population Description
All treated patients
reporting Status
POSTED
time Frame
Up to 12 months
title
Incidence of Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

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