Participant flow

Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma · Source last updated 2026-04-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Nivolumab and dose escalation of Cetuximab. Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\^2; Nivolumab 240 mg. Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2.

   id

   FG000

   title

   Phase I - Lead in

2. description

   Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2.

   id

   FG001

   title

   Phase II- Cohort A

3. description

   Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2.

   id

   FG002

   title

   Phase II - Cohort B

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         5

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         44

      3. group Id

         FG002

         num Subjects

         48

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         42

      3. group Id

         FG002

         num Subjects

         43

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         5

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants in lead-in were included in Cohort A for outcome measure data.

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Preserved source evidence · Not medical advice