At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
In Brief
A Phase 3 clinical trial evaluating Monalizumab, Cetuximab, and 1 other intervention for Squamous Cell Carcinoma of the Head and Neck. Active but no longer recruiting, targeting 370 participants across 127 sites in 23 countries.
Signals
Detailed Summary
This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer
Study Details
Timeline
Arms & Interventions
Participants will receive 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 one week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Participants will receieve 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.
Interventions
Participants will receive IV infusion of monalizumab as stated in arm description.
Participants will receive IV infusion of cetuximab as stated in arm description.
Participants will receive IV infusion of placebo as stated in arm description.