New hope for head and neck cancer: drug combo trial underway

NCT ID NCT04590963

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding monalizumab to the standard drug cetuximab helps people with recurrent or metastatic head and neck cancer live longer. The study includes 370 adults who have already tried an immune checkpoint inhibitor and platinum-based chemotherapy. Participants receive either monalizumab plus cetuximab or a placebo plus cetuximab, and researchers track overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: monalizumab and cetuximab
What this could lead to: If successful, this combination could offer a new treatment option for people with advanced head and neck cancer who have already tried other therapies.
What could go wrong: This is a late-stage trial, but the results are not yet final. The drug may not improve survival significantly, and side effects from the combination could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

370 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms head and neck squamous cell carcinoma laryngeal disorder Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Squamous cell carcinoma of the head and neck

Contacts and locations

Locations

Research Site

Tucson, Arizona, 85719, United States
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Chicago, Illinois, 60612, United States
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Westwood, Kansas, 66205, United States
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Boston, Massachusetts, 02215, United States
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Ann Arbor, Michigan, 48109, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Las Vegas, Nevada, 89169, United States
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New York, New York, 10029, United States
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Charlotte, North Carolina, 28204, United States
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Winston-Salem, North Carolina, 27103, United States
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Columbus, Ohio, 43210, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Dallas, Texas, 75246, United States
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Houston, Texas, 77090, United States
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CABA, 1426, Argentina
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CABA, C1012AAR, Argentina
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CABA, C1426ANZ, Argentina
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Camperdown, 2050, Australia
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Elizabeth Vale, 5112, Australia
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Heidelberg, 3084, Australia
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Melbourne, 3000, Australia
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Linz, 4010, Austria
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Brussels, 1200, Belgium
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Leuven, 3000, Belgium
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Namur, 5000, Belgium
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Roeselare, 8800, Belgium
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Belo Horizonte, 30110-022, Brazil
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Porto Alegre, 90560-030, Brazil
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Rio de Janeiro, 22271-110, Brazil
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São Paulo, 01321-001, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 04543-000, Brazil
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Panagyurishte, 4500, Bulgaria
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Plovdiv, 4004, Bulgaria
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Sofia, 1527, Bulgaria
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Victoria, British Columbia, V8R 6V5, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Avignon, 84918, France
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Bordeaux, 33000, France
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Clermont-Ferrand, 63011, France
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Dijon, 21079, France
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Lyon, 69373, France
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Marseille, 13005, France
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Montpellier, 34298, France
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Strasbourg, 67033, France
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Berlin, 12203, Germany
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Essen, 45122, Germany
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Freiburg im Breisgau, 79106, Germany
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Hanover, 30625, Germany
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Leipzig, 04103, Germany
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Ulm, 89081, Germany
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Würzburg, 97070, Germany
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Athens, 11528, Greece
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Chaïdári, 124 62, Greece
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Thessaloniki, 54645, Greece
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Brescia, 25123, Italy
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Candiolo, 10060, Italy
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Florence, 50134, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Modena, 41124, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Chūōku, 104-0045, Japan
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Fukuoka, 811-1395, Japan
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Hiroshima, 734-8551, Japan
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Isehara-shi, 259-1193, Japan
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Kashiwa, 277-8577, Japan
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Kobe, 650-0017, Japan
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Kōtoku, 135-8550, Japan
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Okayama, 700-8558, Japan
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Sayama, 589-8511, Japan
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Sunto-gun, 411-8777, Japan
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Yokohama, 236-0004, Japan
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Yokohama, 241-8515, Japan
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Amsterdam, 1066 CX, Netherlands
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Maastricht, 6229 HX, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Manila, 1000, Philippines
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Pasig, 1605, Philippines
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Quezon City, 1112, Philippines
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Bialystok, 15-027, Poland
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Bydgoszcz, 85-796, Poland
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Poznan, 61-866, Poland
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Coimbra, 3000-075, Portugal
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Porto, 4099-001, Portugal
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Porto, 4200-319, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Moscow, 115478, Russia
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Moscow Region, 143081, Russia
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Obninsk, 249036, Russia
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Saint Petersburg, 191014, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Busan, 49267, South Korea
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Cheongju-si, 28644, South Korea
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Goyang-si, 10408, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 06351, South Korea
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Seoul, 110-744, South Korea
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Seoul, 138-736, South Korea
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Barcelona, 08035, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Valencia, 46014, Spain
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Lausanne, CH-1011, Switzerland
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Changhua, 500, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 112, Taiwan
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Taipei, 235, Taiwan
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Sutton, SM2 5PT, United Kingdom

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