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NCT04576091 · FLOW

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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.

groups
  1. description
    All participants received the same dose level. All patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, all patients also received 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. Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: blood sample collection Computed Tomography: CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: SBRT
    id
    FG000
    title
    Treatment (Pembrolizumab, BAY 1895344, SBRT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Note: One (1) patient started pembro but not the study drug and was lost to follow-up completely after the first dose of pembro.
Complete source fields
groups
  1. description
    All participants received the same dose level. All patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, all patients also received 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. Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial. Biospecimen Collection: blood sample collection Computed Tomography: CT and/or PET-CT scan Elimusertib: Given PO Pembrolizumab: Given IV Positron Emission Tomography: PET-CT scan Quality-of-Life Assessment: Ancillary studies Stereotactic Body Radiation Therapy: SBRT
    id
    FG000
    title
    Treatment (Pembrolizumab, BAY 1895344, SBRT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Note: One (1) patient started pembro but not the study drug and was lost to follow-up completely after the first dose of pembro.

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

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