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Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer
Trial Status: closed to accrual
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.
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)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04590963.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
Participants with recurrent or metastatic squamous cell carcinoma of the head and neck
(SCCHN) who had prior immune checkpoint inhibitor and platinum-based chemotherapy
treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and
cetuximab. Efficacy and safety assessments will be performed periodically from the time
of enrollment and throughout the study. Participants in all arms will continue therapy
until progression, unacceptable toxicity, withdrawal of consent, or another
discontinuation criterion is met. All Participants will be followed for survival after
