Baseline characteristics

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.

denoms

1. counts

   1. group Id

      BG000

      value

      6

   units

   Participants

groups

1. description

   Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 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 undergo SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 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

   BG000

   title

   Treatment (Pembrolizumab, BAY 1895344, SBRT)

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            63

            upper Limit

            92

            value

            67

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            6

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            5

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            1

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Ethnicity (NIH/OMB)

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            1

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            0

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            0

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            5

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            0

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            0

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

5. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         title

         ECOG = 0

      2. measurements

         1. group Id

            BG000

            value

            5

         title

         ECOG = 1

   description

   0 - Fully active, able to carry on all pre-disease performance without restriction 1. \- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2. \- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. \- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. \- Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. \- Dead

   param Type

   COUNT_OF_PARTICIPANTS

   title

   ECOG

   unit Of Measure

   Participants

6. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         title

         2 prior lines of therapy

      2. measurements

         1. group Id

            BG000

            value

            4

         title

         3 prior lines of therapy

      3. measurements

         1. group Id

            BG000

            value

            1

         title

         4 prior lines of therapy

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Number Lines of Prior Therapy

   unit Of Measure

   Participants

population Description

All enrolled patients

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