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

NCT04590963 · tracked via the Priya Life Science Italy tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2020-10-02

Last updated

2026-09-09

Condition(s) studied

Squamous Cell Carcinoma of the Head and Neck

Investigational drug(s) / intervention(s)

Monalizumab →Cetuximab →Placebo

Monalizumab: Participants will receive IV infusion of monalizumab as stated in arm description.

Cetuximab: Participants will receive IV infusion of cetuximab as stated in arm description.

Placebo: Participants will receive IV infusion of placebo as stated in arm description.

Study 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

Sex

ALL

Min age

18 Years

Max age

130 Years

Healthy volunteers

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)

Primary outcome measure(s)

Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set — Baseline (-28 to -1) through 17.5 months (maximum observed duration)
The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analyses were stratified on World Health Organization/ Eastern Cooperative Oncology Group performance status (WHO/ECOG PS) (0 or 1) and number of prior lines of therapy in recurrent or metastatic (R/M) setting (1 or 2).

Trial sites (127)

Facility	City	Region
Research Site	Tucson	Arizona
Research Site	Chicago	Illinois
Research Site	Westwood	Kansas
Research Site	Boston	Massachusetts
Research Site	Ann Arbor	Michigan
Research Site	Rochester	Minnesota
Research Site	St Louis	Missouri
Research Site	Las Vegas	Nevada
Research Site	New York	New York
Research Site	Charlotte	North Carolina
Research Site	Winston-Salem	North Carolina
Research Site	Columbus	Ohio
Research Site	Philadelphia	Pennsylvania
Research Site	Philadelphia	Pennsylvania
Research Site	Pittsburgh	Pennsylvania
Research Site	Dallas	Texas
Research Site	Houston	Texas
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	Brussels	Belgium
Research Site	Leuven	Belgium
Research Site	Namur	Belgium
Research Site	Roeselare	Belgium
Research Site	Belo Horizonte	Brazil
Research Site	Porto Alegre	Brazil
Research Site	Rio de Janeiro	Brazil
Research Site	São Paulo	Brazil
Research Site	São Paulo	Brazil
Research Site	São Paulo	Brazil
Research Site	São Paulo	Brazil
Research Site	Panagyurishte	Bulgaria
Research Site	Plovdiv	Bulgaria
Research Site	Sofia	Bulgaria
Research Site	Victoria	British Columbia

+ 87 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04590963 on ClinicalTrials.gov ↗ ← All trials in Italy