Clinical trialNCT04590963Active, not recruitingPhase 3Interventional

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

SponsorAstraZenecaEnrollment370Squamous Cell Carcinoma of the Head and Neck

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Dario Ruscica, MD
AstraZeneca, Cambridge, UK
Study Director
clinicaltrials.gov ↗
Jérôme Fayette, MD
Centre Leon Berard
Principal Investigator
clinicaltrials.gov ↗
Roger B Cohen, MD
Abramson Cancer Center, Perelman Center for Advanced Medicine
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

127 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina

Research Site
CABA, Argentina
Research Site
CABA, Argentina
Research Site
CABA, Argentina

Australia

Research Site
Camperdown, Australia
Research Site
Elizabeth Vale, Australia
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Heidelberg, Australia
Research Site
Melbourne, Australia

Austria

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Linz, Austria

Belgium

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Brussels, Belgium
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Leuven, Belgium
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Namur, Belgium
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Roeselare, Belgium

Brazil

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Belo Horizonte, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
Research Site
São Paulo, Brazil

Bulgaria

Research Site
Panagyurishte, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria

Canada

Research Site
Victoria, British Columbia, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada

France

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Avignon, France
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Bordeaux, France
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Clermont-Ferrand, France
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Dijon, France
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Lyon, France
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Marseille, France
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Montpellier, France
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Strasbourg, France

Germany

Research Site
Berlin, Germany
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Essen, Germany
Research Site
Freiburg im Breisgau, Germany
Research Site
Hanover, Germany
Research Site
Leipzig, Germany

87 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cetuximab →Monalizumab

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Oct 2020
Primary completion: 11 May 2022
Completion: 24 Sept 2026
Last update posted: 1 Jun 2026
Registered enrollment: 370
Registry id: NCT04590963

Cross-registrations

EU-CTR / CTIS (EudraCT)2019-004770-25EU-CTR / CTIS (EudraCT)2024-511813-39-00

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.