Baseline characteristics

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer · Source last updated 2026-09-09

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

      247

   2. group Id

      BG001

      value

      123

   3. group Id

      BG002

      value

      370

   units

   Participants

groups

1. description

   Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

   id

   BG000

   title

   Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2

2. description

   Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

   id

   BG001

   title

   Placebo Q2W + Cetuximab 400 mg/m^2

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            10.4

            value

            62.0

         2. group Id

            BG001

            spread

            9.6

            value

            61.4

         3. group Id

            BG002

            spread

            10.1

            value

            61.8

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   Years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            42

         2. group Id

            BG001

            value

            29

         3. group Id

            BG002

            value

            71

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            205

         2. group Id

            BG001

            value

            94

         3. group Id

            BG002

            value

            299

         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

            12

         2. group Id

            BG001

            value

            5

         3. group Id

            BG002

            value

            17

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            223

         2. group Id

            BG001

            value

            114

         3. group Id

            BG002

            value

            337

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            12

         2. group Id

            BG001

            value

            4

         3. group Id

            BG002

            value

            16

         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

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            66

         2. group Id

            BG001

            value

            30

         3. group Id

            BG002

            value

            96

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            3

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            3

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            169

         2. group Id

            BG001

            value

            89

         3. group Id

            BG002

            value

            258

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            9

         2. group Id

            BG001

            value

            4

         3. group Id

            BG002

            value

            13

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

population Description

Baseline analysis population included all participants randomized up to the safety DCO date of 01Sep2022.

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

Preserved source evidence · Not medical advice