Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Monalizumab; Cetuximab; Placebo
Intervention description: 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.
Intervention MeSH terms: Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel study. Participants will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blinded study
Enrollment: 370.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: head and neck cancer; Squamous Cell Carcinoma of the Head and Neck; monalizumab; cetuximab; Erbitux; oral cavity; larynx; pharynx; natural killer; oropharynx; hypopharynx

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are aged 18 years and over

          -  Recurrent or metastatic squamous cell carcinoma of the SCCHN, oral cavity, oropharynx,
             hypopharynx, or larynx which has progressed on or after previous systemic cancer
             therapy and is not amenable to curative therapy

          -  Received prior treatment using a programmed cell death ligand-1 (PD-L1) inhibitor

          -  Prior platinum failure

          -  Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN

          -  Has measurable disease per RECIST 1.1

          -  A fresh or recently acquired tumor tissue for the purpose of biomarker testing

          -  World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance
             Status of 0 or 1

        Exclusion Criteria:

          -  Head and neck cancer of any primary anatomic location in the head and neck not
             specified in the inclusion criteria, including participants with SCCHN of unknown
             primary or non-squamous histologies

          -  Had prior cetuximab therapy (unless it was administered in curative locally advanced
             setting with radiotherapy and no disease progression for at least 6 months following
             the last cetuximab dose)

          -  Active or prior documented autoimmune or inflammatory disorders (including
             inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis

          -  Any concurrent anticancer treatment, except for hormonal therapy for
             non-cancer-related conditions (eg, hormone replacement therapy)