Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3eVOLVE-HNSCCNCT06129864

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

A Phase 3 study testing volrustomig in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by AstraZeneca at 306 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT). Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Locally Advanced Head and Neck Squamous Cell Carcinoma
What is being tested?: volrustomig
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,145 participants
Where: 306 sitesin 23 countries
Study dates: 14 Dec 2023to 28 Feb 2031
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization.

Who cannot join

Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1 primary tumors are not eligible for the study.
Participants with any of the following:
LA-HNSCC that was resected before definitive cCRT
LA-HNSCC that was treated and is recurrent at the time of screening
Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.

Trial locations and contacts

306 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

306 sites in 23 countries

United States70 sites, 46 recruiting

Research Site
Albuquerque, New Mexico, 87108
Active, not recruiting
Research Site
Ann Arbor, Michigan, 48105
Recruiting
Research Site
Ann Arbor, Michigan, 48109
Withdrawn
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Aurora, Colorado, 80045
Recruiting
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Austin, Texas, 78745
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Baltimore, Maryland, 21231
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Baton Rouge, Louisiana, 70817
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Bethesda, Maryland, 20817
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Birmingham, Alabama, 35233
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Boston, Massachusetts, 02215
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Charlotte, North Carolina, 28204
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Cleveland, Ohio, 44106
Withdrawn
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Colorado Springs, Colorado, 80909
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Columbia, Missouri, 65211
Withdrawn
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Dallas, Texas, 75251
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Des Moines, Iowa, 50309
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East Brunswick, New Jersey, 08816
Withdrawn
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Fairfax, Virginia, 22031
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Fairhaven, Massachusetts, 02719
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Flower Mound, Texas, 75028
Withdrawn
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Fort Myers, Florida, 33901
Recruiting
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Fountain Valley, California, 92708
Recruiting
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Fullerton, California, 92835
Not yet recruiting
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Gainesville, Florida, 32610
Withdrawn
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Hackensack, New Jersey, 07601
Recruiting
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Houston, Texas, 77030
Withdrawn
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Hyattsville, Maryland, 20782
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Kansas City, Kansas, 66160
Completed
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Lone Tree, Colorado, 80124
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Los Angeles, California, 90024
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Louisville, Kentucky, 40202
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Miami, Florida, 33125
Withdrawn
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Minneapolis, Minnesota, 55417
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Nashville, Tennessee, 37212
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New Brunswick, New Jersey, 08901
Active, not recruiting
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New York, New York, 10065
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New York, New York, 10075
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Niles, Illinois, 60714
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Norfolk, Virginia, 23502
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Odessa, Texas, 79761
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Orange, California, 92868
Withdrawn
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Palm Bay, Florida, 32909
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Philadelphia, Pennsylvania, 19107
Withdrawn
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Phoenix, Arizona, 85028
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Pittsburgh, Pennsylvania, 15261
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Portland, Oregon, 97213
Withdrawn
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Portland, Oregon, 97239
Completed
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Prescott Valley, Arizona, 86314
Active, not recruiting
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Richmond, Virginia, 23230
Withdrawn
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Salt Lake City, Utah, 84112
Recruiting
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Santa Rosa, California, 95403
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Shreveport, Louisiana, 71101
Withdrawn
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Sioux Falls, South Dakota, 57104
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Sioux Falls, South Dakota, 57105
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Spokane, Washington, 99204
Withdrawn
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Springdale, Arkansas, 72762
Withdrawn
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St Louis, Missouri, 63110
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St Louis, Missouri, 63110
Withdrawn
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Stony Brook, New York, 11794
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Tacoma, Washington, 98405
Withdrawn
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Tacoma, Washington, 98415
Active, not recruiting
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Towson, Maryland, 21204
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Tyler, Texas, 75702
Withdrawn
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Upper Marlboro, Maryland, 20774
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Washington D.C., District of Columbia, 20037
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West Jordan, Utah, 84088
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West Palm Beach, Florida, 33401
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Whittier, California, 90602
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Winston-Salem, North Carolina, 27157
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York, Pennsylvania, 17403
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Other trials in United States

China40 sites, 32 recruiting

Research Site
Beijing, 100142
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Beijing, 100210
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Bengbu, 233004
Withdrawn
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Changchun, 130000
Withdrawn
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Changsha, 410008
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Changsha, 410013
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Chengdu, 610000
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Chengdu, 610042
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Chengdu, 610072
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Chongqing, 400016
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Chongqing, 400030
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Dongwan, 523058
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Fuzhou, 350014
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Guangzhou, 510060
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Guangzhou, 510080
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Guangzhou, 510095
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Guangzhou, 510700
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Guiyang, 550002
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Hangzhou, 310022
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Harbin, 150049
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Hefei, 230001
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Huizhou, 516001
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Jinan, 250117
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Kunming, 650118
Withdrawn
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Lanzhou, 730000
Withdrawn
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Nanchang, 330029
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Nanning, 530021
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Shanghai, 20032
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Shenyang, 110004
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Shijiazhuang, 050000
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Tianjin, 300060
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Tianjin, 300060
Withdrawn
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Ürümqi, 830000
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Wuhan, 430030
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Wuhan, 430060
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Wuxi, 214122
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Xi'an, 710061
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Xiamen, 361003
Withdrawn
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Zhengzhou, 450008
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Zhuhai, 519000
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Other trials in China

Japan26 sites, 26 recruiting

Research Site
Bunkyō City, 113-8431
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Bunkyō City, 113-8519
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Chiba, 260-8677
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Chiba, 260-8717
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Chūōku, 104-0045
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Fukuoka, 811-1395
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Hidaka-shi, 350-1298
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Hiroshima, 734-8551
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Kashiwa, 277-8577
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Kobe, 650-0017
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Kōtoku, 135-8550
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Kyoto, 606-8507
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Nagoya, 464-8681
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Nagoya, 466-8560
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Niigata, 951-8520
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Okayama, 700-8558
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Osaka, 541-8567
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Osakasayama-shi, 589-8511
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Sagamihara-shi, 252-0375
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Sapporo, 060-8638
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Sendai, 980-8574
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Shinjuku-ku, 160-0023
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Shiwa-gun, 028-3695
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Sunto-gun, 411-8777
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Yokohama, 236-0004
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Yokohama, 241-8515
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Other trials in Japan

Germany14 sites, 14 recruiting

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Berlin, 12200
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Erlangen, 91054
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Essen, 45122
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Freiburg im Breisgau, 79106
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Greifswald, 17475
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Hamburg, 20246
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Hanover, 30625
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Leipzig, 04103
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Lübeck, 23538
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München, 81675
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Rostock, 18059
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Tübingen, 72076
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Ulm, 89075
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Würzburg, 97070
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Other trials in Germany

India14 sites, 10 recruiting

Research Site
Bengaluru, 560027
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Hyderabad, 500032
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Jaipur, 302022
Withdrawn
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Kanpur, 208005
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Kochi, 682027
Active, not recruiting
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Kolkata, 700099
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Lucknow, 226003
Withdrawn
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Madurai, 625107
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Mohali, 160055
Withdrawn
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Nashik, 422002
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New Delhi, 110076
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Thiruvananthapuram, 695011
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Vadodara, 391760
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Varanasi, 221005
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Other trials in India

Brazil13 sites, 11 recruiting

Research Site
Barretos, 14784-400
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Florianópolis, 88034-000
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Fortaleza, 60336-045
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Ijuí, 98700-000
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Ipatinga, 35162-189
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Londrina, 86015-520
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Natal, 59075-740
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Porto Alegre, 91350200
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Ribeirão Preto, 14051-140
Suspended
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Rio de Janeiro, 20231-050
Suspended
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São Paulo, 01509-900
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São Paulo, 04538-132
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Teresina, 64049-200
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Other trials in Brazil

United Kingdom12 sites, 10 recruiting

Research Site
Aberdeen, AB25 2ZN
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Cambridge, CB2 0XY
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Hampshire, SO16 6YD
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Leeds, LS9 7TF
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London, EC1A 7BE
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London, SE1 9RT
Withdrawn
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London, SW3 6JJ
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Manchester, M20 4BX
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Metropolitan Borough of Wirral, CH63 4JY
Withdrawn
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Northwood, HA6 2RN
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Sutton, SM2 5PT
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Taunton, TA1 5DA
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Other trials in United Kingdom

Canada11 sites, 8 recruiting

Research Site
Calgary, Alberta, T2N 5G2
Recruiting
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Chicoutimi, Quebec, G7H 5H6
Not yet recruiting
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Edmonton, Alberta, T6G 1Z2
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Kelowna, British Columbia, V1Y 5L3
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Kingston, Ontario, K7L 2V7
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London, Ontario, N6A 5W9
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Montreal, Quebec, H2X 0C1
Completed
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Montreal, Quebec, H3T 1E2
Terminated
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Montreal, Quebec, H4A 3J1
Recruiting
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Regina, S4T 7T1
Withdrawn
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Toronto, Ontario, M4N 3M5
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Other trials in Canada

Hungary11 sites, 11 recruiting

Research Site
Budapest, 1062
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Budapest, 1083
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Budapest, 1122
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Budapest, 1145
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Győr, 9024
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Gyula, 5700
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Kecskemét, 6000
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Miskolc, 3526
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Nyíregyháza, 4400
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Pécs, 7624
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Research Site
Szekszárd, 7100
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Other trials in Hungary

Poland9 sites, 8 recruiting

Research Site
Bialystok, 15-027
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Bielsko-Biala, 43-300
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Bydgoszcz, 85-796
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Research Site
Gliwice, 44-102
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Research Site
Olsztyn, 10-228
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Piotrkow Trybunalski, 97-300
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Siedlce, 08-110
Recruiting
Research Site
Tomaszów Mazowiecki, 97-200
Withdrawn
Research Site
Warsaw, 02-781
Recruiting

Other trials in Poland

Spain9 sites, 9 recruiting

Research Site
Badalona, 08916
Recruiting
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Barcelona, 08035
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Barcelona, 08036
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Jaén, 23007
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Madrid, 28007
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Madrid, 28034
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Madrid, 28040
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Valencia, 46014
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Valencia, 46026
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Other trials in Spain

Thailand9 sites, 8 recruiting

Research Site
Bangkok, 10300
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Bangkok, 10400
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Bangkok, 10700
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Research Site
Chaing Mai, 50200
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Research Site
Hat Yai, 90110
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Research Site
Khon Kaen, 40002
Withdrawn
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Lampang, 52000
Recruiting
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Muang, 22000
Recruiting
Research Site
Mueang, 20000
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Other trials in Thailand

France8 sites, 8 recruiting

Research Site
Avignon, 84918
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Bordeaux, 33075
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Le Mans, 72000
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Lyon, 69373
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Nice, 06100
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Saint-Herblain, 44805
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Toulouse, 31059
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Villejuif, 94805
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Other trials in France

Italy8 sites, 8 recruiting

Research Site
Aviano, 33081
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Florence, 50139
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Milan, 20133
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Modena, 41124
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Naples, 80131
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Padova, 35128
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Pavia, 27100
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Rozzano, 20089
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Other trials in Italy

Taiwan8 sites, 8 recruiting

Research Site
Changhua, 500
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Kaohsiung City, 80756
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Kaohsiung City, 833401
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Taichung, 404
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Taichung, 40705
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Taipei, 10002
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Taipei, 11217
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Research Site
Taoyuan, 333
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Other trials in Taiwan

Philippines7 sites, 4 recruiting

Research Site
Cebu City, 6000
Withdrawn
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General Santos, 9500
Not yet recruiting
Research Site
Iloilo City, 5000
Recruiting
Research Site
Manila, 1008
Not yet recruiting
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Pasig, 1605
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Research Site
Quezon City, 1112
Withdrawn
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West San Juan City, 1502
Withdrawn

Other trials in Philippines

South Korea7 sites, 7 recruiting

Research Site
Goyang-si, 410-769
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Gyeonggi-do, 13620
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Incheon, 21565
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Seoul, 06351
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Seoul, 3722
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Seoul, 5505
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Suwon, 16247
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Other trials in South Korea

Turkey (Türkiye)7 sites, 6 recruiting

Research Site
Ankara, 06230
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Ankara, 6200
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Antalya, 07059
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Cordaleo, 35575
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Eskişehir, 26040
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Istanbul, 34722
Withdrawn
Research Site
Yenimahalle, 06170
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Other trials in Turkey (Türkiye)

Malaysia6 sites, 6 recruiting

Research Site
George Town, 10450
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Johor Bahru, 81100
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Kuala Lumpur, 50586
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Kuala Lumpur, 59100
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Kuala Selangor, 62250
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Research Site
Kuching, 93586
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Other trials in Malaysia

Vietnam6 sites, 6 recruiting

Research Site
Da Nang, 550000
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Hà Nội, 100000
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Hanoi, 100000
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Ho Chi Minh City, 700000
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Huế, 530000
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Vinh, 460000
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Other trials in Vietnam

Austria5 sites, 5 recruiting

Research Site
Graz, 8036
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Innsbruck, 6020
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Linz, 4010
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Salzburg, 5020
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Vienna, 1080
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Other trials in Austria

Belgium5 sites, 5 recruiting

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Charleroi, 6060
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Edegem, 2650
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Jette, 1090
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La Louvière, 7100
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Namur, 5000
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Other trials in Belgium

Puerto Rico1 site

Research Site
San Juan, 00927
Completed

Other trials in Puerto Rico

About this study

Official title: A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Being tested: volrustomig

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

volrustomigDrug
Also called MEDI5752
volrustomig

Study groups in NCT06129864
Study group	Role	What they receive
Study Arm	Experimental	Participants in this arm will receive volrustomig. Receives: Drug: volrustomig
Observation Arm	No intervention	Patients in this arm will undergo observation.

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression).
The analysis will include all randomized participants with PD-L1 expressing tumors.
Measured: Up to approximately 8 years

Secondary outcomes (13)

Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression).
The analysis will include all randomized participants.
Measured: Up to approximately 8 years
Landmark Progression-Free Survival (PFS) Rates
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression).
These analyses will include participants with PD-L1 expressing tumors and all randomized participants.
Measured: Up to approximately 8 years
Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Overall survival (OS) is defined as the time from randomization until the date of death due to any cause.
The analysis will include all randomized participants with PD-L1 expressing tumors.
Measured: Up to approximately 8 years
Landmark Overall Survival (OS) Rates
OS is defined as the time from randomization until the date of death due to any cause.
These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants.
Measured: Up to approximately 8 years
Overall Survival (OS) in the unresected LA-HNSCC ITT population
OS is defined as the time from randomization until the date of death due to any cause.
The analysis will include all randomized participants.
Measured: Up to approximately 8 years
Progression Free Survival 2 (PFS2)
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.
These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants.
Measured: Up to approximately 8 years
Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum
To investigate the immunogenicity of volrustomig.
Measured: Up to approximately 8 years
Participant-reported physical functioning
Change from baseline of physical functioning as measured by scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v.20 - Physical Function 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning.
The analysis will include all randomized participants.
Measured: Up to approximately 8 years
Participant-reported global health status (GHS)/quality of life (QoL)
Change from baseline of Global Health Status/Quality of Life subscale scores as measured by the European Organization for Research and Treatment of Cancer (EORTC) Item Library 172 are transformed to a 0-100 range; a higher score represents higher quality of life.
The analysis will include all randomized participants.
Measured: Up to approximately 8 years
Percentage of participants with Adverse Events
Adverse Events as assessed by Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Up to approximately 8 years
Area under the curve (AUC)
The concentration of Volrustomig in serum will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
Measured: Up to approximately 8 years
Maximum plasma concentration of the drug (Cmax)
The concentration of Volrustomig in serum will be determined (Cmax will be derived).
Measured: Up to approximately 8 years
The time taken to reach the maximum concentration (Tmax)
The concentration of Volrustomig in serum will be determined (Tmax will be derived).
Measured: Up to approximately 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 202328 Feb 2031

First posted13 Nov 2023
Study start14 Dec 2023
Primary completion17 Apr 2030 (estimated)
Study completion28 Feb 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,145 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06129864
Sponsor's protocol ID: D798EC00001
Acronym: eVOLVE-HNSCC
Status last verified: Sep 2026
First submitted: 3 Nov 2023
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruitingPhase 1/2
Intravenously Administered PROMITIL Combined With Radiotherapy in Patients With Cisplatin-Ineligible Head and Neck Cancer Patients
Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy
Squamous Cell Carcinoma of Head and Neck (SCCHN)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma

All Locally Advanced Head and Neck Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)
ClinicalTrials.gov ID: NCT06129864
Acronym / sponsor ID: eVOLVE-HNSCC / D798EC00001
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,145 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 14 Dec 2023 (actual)
Primary completion: 17 Apr 2030 (estimated)
Study completion: 28 Feb 2031 (estimated)
First posted: 13 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Study Arm	Experimental	Drug: volrustomigParticipants in this arm will receive volrustomig.
Observation Arm	No intervention	–Patients in this arm will undergo observation.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization.

Key exclusion criteria (5 listed)

Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1 primary tumors are not eligible for the study.
Participants with any of the following:
Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
volrustomigAlso: MEDI5752volrustomig	Drug	Study Arm

Primary outcome

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Time frame: Up to approximately 8 years
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.

13 secondary outcomes

Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population
Time frame: Up to approximately 8 years
Landmark Progression-Free Survival (PFS) Rates
Time frame: Up to approximately 8 years
Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Time frame: Up to approximately 8 years
Landmark Overall Survival (OS) Rates
Time frame: Up to approximately 8 years
Overall Survival (OS) in the unresected LA-HNSCC ITT population
Time frame: Up to approximately 8 years
Progression Free Survival 2 (PFS2)
Time frame: Up to approximately 8 years
Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum
Time frame: Up to approximately 8 years
Participant-reported physical functioning
Time frame: Up to approximately 8 years
Participant-reported global health status (GHS)/quality of life (QoL)
Time frame: Up to approximately 8 years
Percentage of participants with Adverse Events
Time frame: Up to approximately 8 years
Area under the curve (AUC)
Time frame: Up to approximately 8 years
Maximum plasma concentration of the drug (Cmax)
Time frame: Up to approximately 8 years
The time taken to reach the maximum concentration (Tmax)
Time frame: Up to approximately 8 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Related trials for Locally Advanced Head and Neck Squamous Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruitingPhase 1/2
Intravenously Administered PROMITIL Combined With Radiotherapy in Patients With Cisplatin-Ineligible Head and Neck Cancer Patients
Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 2
Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy
Squamous Cell Carcinoma of Head and Neck (SCCHN)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Robert Haddad, MD study chair

Dana Farber Cancer Institute Massachusetts, USA

Lisa Licitra, MD study chair

Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy

306 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing volrustomig in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by AstraZeneca at 306 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 306 sites in United States, China, Japan, Germany, India and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors (time frame: Up to approximately 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06129864.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.