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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

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

Key facts

Study ID

NCT04590963

Run by

AstraZeneca

People needed

370

Starts

2020-10-02

Expected to finish

2026-09-24

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Research Site — Chicago, Illinois, United States
• Research Site — Westwood, Kansas, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — New York, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — CABA, Argentina
• Research Site — CABA, Argentina
• Research Site — CABA, Argentina
• Research Site — Camperdown, Australia
• Research Site — Elizabeth Vale, Australia
• Research Site — Heidelberg, Australia
• Research Site — Melbourne, Australia
• Research Site — Linz, Austria
• Research Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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