Participant flow

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.

groups

1. description

   Participants received intravenous (IV) monalizumab 750 mg every two weeks (Q2W) and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 every 1 week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

   id

   FG000

   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

   FG001

   title

   Placebo Q2W + Cetuximab 400 mg/m^2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         118

      2. group Id

         FG001

         num Subjects

         59

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Progressive disease

   4. reasons

      1. group Id

         FG000

         num Subjects

         103

      2. group Id

         FG001

         num Subjects

         50

      type

      Study terminated by sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         4

      type

      Ongoing at data cut-off

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Screen failure

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         247

      2. group Id

         FG001

         num Subjects

         123

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         246

      2. group Id

         FG001

         num Subjects

         122

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         247

      2. group Id

         FG001

         num Subjects

         123

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 370 participants were randomized (All randomized participants \[ARP\] set) in this study of which 368 participants received treatment. The analyses presented in this report are based on a clinical efficacy data cut-off (DCO) date of 11May2022, and clinical safety DCO date of 01Sep2022.

recruitment Details

The study was conducted at study sites located in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Philippines, Poland, Portugal, Republic of Korea, Russia, Spain, Switzerland, Taiwan, United Kingdom, and United States of America.

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

Preserved source evidence · Not medical advice