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NCT04576091 · OUTCOME

Incidence of Dose Limiting Toxicities (DLT)

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
participants
Interval / dispersion
Not reported
Time frame
Within 90 days of treatment initiation

What was measured

Number of patients who experienced Dose Limiting Toxicities. DLTs are defined as occurrence of any of the following events, if judged by the Investigator to be possibly, probably or definitely related to study drug administration 1. Any Grade 4 or greater adverse event per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0) observed within 90 days of the last dose of radiation therapy. 2. Grade 3 nonhematologic toxicity (not laboratory) lasting \>5 days despite optimal supportive care. 3. Any Grade 3 nonhematologic laboratory value if: • Medical intervention is required to treat the patient, or • The abnormality leads to hospitalization, or • The abnormality persists for \>1 week. 4. Febrile neutropenia. 5. Thrombocytopenia \<25000/mm3 if associated with bleeding requiring intervention. 6. Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity.

Analysis population: All enrolled patients were treated at the lowest dose level.

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 participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, BAY 1895344, SBRT)6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Number of patients who experienced Dose Limiting Toxicities. DLTs are defined as occurrence of any of the following events, if judged by the Investigator to be possibly, probably or definitely related to study drug administration 1. Any Grade 4 or greater adverse event per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0) observed within 90 days of the last dose of radiation therapy. 2. Grade 3 nonhematologic toxicity (not laboratory) lasting \>5 days despite optimal supportive care. 3. Any Grade 3 nonhematologic laboratory value if: • Medical intervention is required to treat the patient, or • The abnormality leads to hospitalization, or • The abnormality persists for \>1 week. 4. Febrile neutropenia. 5. Thrombocytopenia \<25000/mm3 if associated with bleeding requiring intervention. 6. Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity.
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
All enrolled patients were treated at the lowest dose level.
reporting Status
POSTED
time Frame
Within 90 days of treatment initiation
title
Incidence of Dose Limiting Toxicities (DLT)
type
PRIMARY
unit Of Measure
participants

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

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