Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Are aged 18 years and over
  2. 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
  3. Received prior treatment using a programmed cell death ligand-1 (PD-L1) inhibitor
  4. Prior platinum failure
  5. Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
  6. Has measurable disease per RECIST 1.1
  7. A fresh or recently acquired tumor tissue for the purpose of biomarker testing
  8. World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

* 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


EXCLUSION CRITERIA

Exclusion Criteria:


  • 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)

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    Study Locations

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    How to Apply

    Contact the study center to learn if this study is a good match for you.

    Study’s details

    Contition
    Squamous Cell Carcinoma of the Head and Neck
    Age (in years)
    18 - 130
    Phase
    PHASE3
    Participants needed
    370
    Est. Completion Date
    Sep 24, 2025
    Treatment type
    INTERVENTIONAL
    Sponsor
    AstraZeneca
    ClinicalTrials.gov identifier
    NCT04590963
    Study number
    D7310C00001

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