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

NCT ID NCT04590963

Ongoing Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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
Research Site

Chicago, Illinois, 60612, United States
Research Site

Westwood, Kansas, 66205, United States
Research Site

Boston, Massachusetts, 02215, United States
Research Site

Ann Arbor, Michigan, 48109, United States
Research Site

Rochester, Minnesota, 55905, United States
Research Site

St Louis, Missouri, 63110, United States
Research Site

Las Vegas, Nevada, 89169, United States
Research Site

New York, New York, 10029, United States
Research Site

Charlotte, North Carolina, 28204, United States
Research Site

Winston-Salem, North Carolina, 27103, United States
Research Site

Columbus, Ohio, 43210, United States
Research Site

Philadelphia, Pennsylvania, 19104, United States
Research Site

Philadelphia, Pennsylvania, 19111, United States
Research Site

Pittsburgh, Pennsylvania, 15232, United States
Research Site

Dallas, Texas, 75246, United States
Research Site

Houston, Texas, 77090, United States
Research Site

CABA, 1426, Argentina
Research Site

CABA, C1012AAR, Argentina
Research Site

CABA, C1426ANZ, Argentina
Research Site

Camperdown, 2050, Australia
Research Site

Elizabeth Vale, 5112, Australia
Research Site

Heidelberg, 3084, Australia
Research Site

Melbourne, 3000, Australia
Research Site

Linz, 4010, Austria
Research Site

Brussels, 1200, Belgium
Research Site

Leuven, 3000, Belgium
Research Site

Namur, 5000, Belgium
Research Site

Roeselare, 8800, Belgium
Research Site

Belo Horizonte, 30110-022, Brazil
Research Site

Porto Alegre, 90560-030, Brazil
Research Site

Rio de Janeiro, 22271-110, Brazil
Research Site

São Paulo, 01321-001, Brazil
Research Site

São Paulo, 01327-001, Brazil
Research Site

São Paulo, 01509-900, Brazil
Research Site

São Paulo, 04543-000, Brazil
Research Site

Panagyurishte, 4500, Bulgaria
Research Site

Plovdiv, 4004, Bulgaria
Research Site

Sofia, 1527, Bulgaria
Research Site

Victoria, British Columbia, V8R 6V5, Canada
Research Site

Hamilton, Ontario, L8V 5C2, Canada
Research Site

Toronto, Ontario, M4N 3M5, Canada
Research Site

Toronto, Ontario, M5G 2M9, Canada
Research Site

Montreal, Quebec, H3T 1E2, Canada
Research Site

Avignon, 84918, France
Research Site

Bordeaux, 33000, France
Research Site

Clermont-Ferrand, 63011, France
Research Site

Dijon, 21079, France
Research Site

Lyon, 69373, France
Research Site

Marseille, 13005, France
Research Site

Montpellier, 34298, France
Research Site

Strasbourg, 67033, France
Research Site

Berlin, 12203, Germany
Research Site

Essen, 45122, Germany
Research Site

Freiburg im Breisgau, 79106, Germany
Research Site

Hanover, 30625, Germany
Research Site

Leipzig, 04103, Germany
Research Site

Ulm, 89081, Germany
Research Site

Würzburg, 97070, Germany
Research Site

Athens, 11528, Greece
Research Site

Chaïdári, 124 62, Greece
Research Site

Thessaloniki, 54645, Greece
Research Site

Brescia, 25123, Italy
Research Site

Candiolo, 10060, Italy
Research Site

Florence, 50134, Italy
Research Site

Milan, 20132, Italy
Research Site

Milan, 20133, Italy
Research Site

Modena, 41124, Italy
Research Site

Naples, 80131, Italy
Research Site

Padova, 35128, Italy
Research Site

Chūōku, 104-0045, Japan
Research Site

Fukuoka, 811-1395, Japan
Research Site

Hiroshima, 734-8551, Japan
Research Site

Isehara-shi, 259-1193, Japan
Research Site

Kashiwa, 277-8577, Japan
Research Site

Kobe, 650-0017, Japan
Research Site

Kōtoku, 135-8550, Japan
Research Site

Okayama, 700-8558, Japan
Research Site

Sayama, 589-8511, Japan
Research Site

Sunto-gun, 411-8777, Japan
Research Site

Yokohama, 236-0004, Japan
Research Site

Yokohama, 241-8515, Japan
Research Site

Amsterdam, 1066 CX, Netherlands
Research Site

Maastricht, 6229 HX, Netherlands
Research Site

Nijmegen, 6525 GA, Netherlands
Research Site

Manila, 1000, Philippines
Research Site

Pasig, 1605, Philippines
Research Site

Quezon City, 1112, Philippines
Research Site

Bialystok, 15-027, Poland
Research Site

Bydgoszcz, 85-796, Poland
Research Site

Poznan, 61-866, Poland
Research Site

Coimbra, 3000-075, Portugal
Research Site

Porto, 4099-001, Portugal
Research Site

Porto, 4200-319, Portugal
Research Site

Vila Nova de Gaia, 4434-502, Portugal
Research Site

Moscow, 115478, Russia
Research Site

Moscow Region, 143081, Russia
Research Site

Obninsk, 249036, Russia
Research Site

Saint Petersburg, 191014, Russia
Research Site

Saint Petersburg, 195271, Russia
Research Site

Saint Petersburg, 197022, Russia
Research Site

Saint Petersburg, 197758, Russia
Research Site

Busan, 49267, South Korea
Research Site

Cheongju-si, 28644, South Korea
Research Site

Goyang-si, 10408, South Korea
Research Site

Seongnam-si, 13620, South Korea
Research Site

Seoul, 06351, South Korea
Research Site

Seoul, 110-744, South Korea
Research Site

Seoul, 138-736, South Korea
Research Site

Barcelona, 08035, Spain
Research Site

Madrid, 28007, Spain
Research Site

Madrid, 28040, Spain
Research Site

Madrid, 28041, Spain
Research Site

Valencia, 46014, Spain
Research Site

Basel, 4031, Switzerland
Research Site

Bern, 3010, Switzerland
Research Site

Lausanne, CH-1011, Switzerland
Research Site

Changhua, 500, Taiwan
Research Site

Taichung, 40447, Taiwan
Research Site

Taichung, 40705, Taiwan
Research Site

Tainan, 704, Taiwan
Research Site

Taipei, 112, Taiwan
Research Site

Taipei, 235, Taiwan
Research Site

London, SW3 6JJ, United Kingdom
Research Site

Manchester, M20 4BX, United Kingdom
Research Site

Newcastle upon Tyne, NE7 7DN, United Kingdom
Research Site

Sutton, SM2 5PT, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.