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

May 12, 2026 updated by: AstraZeneca

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)

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).

Study Overview

Status

Recruiting

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Intervention / Treatment

Drug: volrustomig

Study Type

Interventional

Enrollment (Estimated)

1145

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Austria
- - Graz, Austria, 8036
    - Recruiting
    - Research Site
  - Innsbruck, Austria, 6020
    - Recruiting
    - Research Site
  - Linz, Austria, 4010
    - Recruiting
    - Research Site
  - Salzburg, Austria, 5020
    - Recruiting
    - Research Site
  - Vienna, Austria, 1080
    - Recruiting
    - Research Site
Belgium
- - Charleroi, Belgium, 6060
    - Recruiting
    - Research Site
  - Edegem, Belgium, 2650
    - Recruiting
    - Research Site
  - Jette, Belgium, 1090
    - Recruiting
    - Research Site
  - La Louvière, Belgium, 7100
    - Recruiting
    - Research Site
  - Namur, Belgium, 5000
    - Recruiting
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Recruiting
    - Research Site
  - Florianópolis, Brazil, 88034-000
    - Recruiting
    - Research Site
  - Fortaleza, Brazil, 60336-045
    - Recruiting
    - Research Site
  - Ijuí, Brazil, 98700-000
    - Recruiting
    - Research Site
  - Ipatinga, Brazil, 35162-189
    - Recruiting
    - Research Site
  - Londrina, Brazil, 86015-520
    - Recruiting
    - Research Site
  - Natal, Brazil, 59075-740
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350200
    - Recruiting
    - Research Site
  - Ribeirão Preto, Brazil, 14051-140
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 20231-050
    - Suspended
    - Research Site
  - São Paulo, Brazil, 04538-132
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01509-900
    - Recruiting
    - Research Site
  - Teresina, Brazil, 64049-200
    - Recruiting
    - Research Site
Canada
- - Regina, Canada, S4T 7T1
    - Withdrawn
    - Research Site
- Alberta
  - Calgary, Alberta, Canada, T2N 5G2
    - Recruiting
    - Research Site
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Recruiting
    - Research Site
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - Recruiting
    - Research Site
- Ontario
  - Kingston, Ontario, Canada, K7L 2V7
    - Recruiting
    - Research Site
  - London, Ontario, Canada, N6A 5W9
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - Not yet recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4A 3J1
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H3T 1E2
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H2X 0C1
    - Completed
    - Research Site
China
- - Beijing, China, 100210
    - Recruiting
    - Research Site
  - Beijing, China, 100142
    - Recruiting
    - Research Site
  - Bengbu, China, 233004
    - Recruiting
    - Research Site
  - Changchun, China, 130000
    - Withdrawn
    - Research Site
  - Changsha, China, 410008
    - Recruiting
    - Research Site
  - Changsha, China, 410013
    - Recruiting
    - Research Site
  - Chengdu, China, 610000
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Chengdu, China, 610042
    - Recruiting
    - Research Site
  - Chongqing, China, 400016
    - Recruiting
    - Research Site
  - Chongqing, China, 400030
    - Recruiting
    - Research Site
  - Dongwan, China, 523058
    - Recruiting
    - Research Site
  - Fuzhou, China, 350014
    - Recruiting
    - Research Site
  - Guangzhou, China, 510080
    - Recruiting
    - Research Site
  - Guangzhou, China, 510060
    - Recruiting
    - Research Site
  - Guangzhou, China, 510095
    - Recruiting
    - Research Site
  - Guangzhou, China, 510700
    - Recruiting
    - Research Site
  - Guiyang, China, 550002
    - Recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Recruiting
    - Research Site
  - Harbin, China, 150049
    - Recruiting
    - Research Site
  - Hefei, China, 230001
    - Recruiting
    - Research Site
  - Huizhou, China, 516001
    - Recruiting
    - Research Site
  - Jinan, China, 250117
    - Recruiting
    - Research Site
  - Kunming, China, 650118
    - Withdrawn
    - Research Site
  - Lanzhou, China, 730000
    - Recruiting
    - Research Site
  - Nanchang, China, 330029
    - Recruiting
    - Research Site
  - Nanning, China, 530021
    - Recruiting
    - Research Site
  - Shanghai, China, 20032
    - Recruiting
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Shijiazhuang, China, 050000
    - Recruiting
    - Research Site
  - Tianjin, China, 300060
    - Recruiting
    - Research Site
  - Tianjin, China, 300060
    - Withdrawn
    - Research Site
  - Wuhan, China, 430030
    - Recruiting
    - Research Site
  - Wuhan, China, 430060
    - Recruiting
    - Research Site
  - Wuxi, China, 214122
    - Withdrawn
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Xiamen, China, 361003
    - Withdrawn
    - Research Site
  - Zhengzhou, China, 450008
    - Recruiting
    - Research Site
  - Zhuhai, China, 519000
    - Recruiting
    - Research Site
  - Ürümqi, China, 830000
    - Withdrawn
    - Research Site
France
- - Avignon, France, 84918
    - Recruiting
    - Research Site
  - Bordeaux, France, 33075
    - Recruiting
    - Research Site
  - Le Mans, France, 72000
    - Recruiting
    - Research Site
  - Lyon, France, 69373
    - Recruiting
    - Research Site
  - Nice, France, 06100
    - Recruiting
    - Research Site
  - Saint-Herblain, France, 44805
    - Recruiting
    - Research Site
  - Toulouse, France, 31059
    - Recruiting
    - Research Site
  - Villejuif, France, 94805
    - Recruiting
    - Research Site
Germany
- - Berlin, Germany, 12200
    - Recruiting
    - Research Site
  - Erlangen, Germany, 91054
    - Not yet recruiting
    - Research Site
  - Essen, Germany, 45122
    - Recruiting
    - Research Site
  - Freiburg im Breisgau, Germany, 79106
    - Not yet recruiting
    - Research Site
  - Greifswald, Germany, 17475
    - Recruiting
    - Research Site
  - Hamburg, Germany, 20246
    - Recruiting
    - Research Site
  - Hanover, Germany, 30625
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Recruiting
    - Research Site
  - Lübeck, Germany, 23538
    - Recruiting
    - Research Site
  - München, Germany, 81675
    - Recruiting
    - Research Site
  - Rostock, Germany, 18059
    - Recruiting
    - Research Site
  - Tübingen, Germany, 72076
    - Recruiting
    - Research Site
  - Ulm, Germany, 89075
    - Recruiting
    - Research Site
  - Würzburg, Germany, 97070
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1083
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1122
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1145
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1062
    - Not yet recruiting
    - Research Site
  - Gyula, Hungary, 5700
    - Recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Recruiting
    - Research Site
  - Kecskemét, Hungary, 6000
    - Recruiting
    - Research Site
  - Miskolc, Hungary, 3526
    - Recruiting
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Recruiting
    - Research Site
  - Pécs, Hungary, 7624
    - Recruiting
    - Research Site
  - Szekszárd, Hungary, 7100
    - Recruiting
    - Research Site
India
- - Bengaluru, India, 560027
    - Recruiting
    - Research Site
  - Hyderabad, India, 500032
    - Recruiting
    - Research Site
  - Jaipur, India, 302022
    - Withdrawn
    - Research Site
  - Kanpur, India, 208005
    - Recruiting
    - Research Site
  - Kochi, India, 682027
    - Recruiting
    - Research Site
  - Kolkata, India, 700099
    - Recruiting
    - Research Site
  - Lucknow, India, 226003
    - Withdrawn
    - Research Site
  - Madurai, India, 625107
    - Recruiting
    - Research Site
  - Mohali, India, 160055
    - Withdrawn
    - Research Site
  - Nashik, India, 422002
    - Recruiting
    - Research Site
  - New Delhi, India, 110076
    - Recruiting
    - Research Site
  - Thiruvananthapuram, India, 695011
    - Recruiting
    - Research Site
  - Vadodara, India, 391760
    - Recruiting
    - Research Site
  - Varanasi, India, 221005
    - Recruiting
    - Research Site
Italy
- - Aviano, Italy, 33081
    - Recruiting
    - Research Site
  - Florence, Italy, 50139
    - Recruiting
    - Research Site
  - Milan, Italy, 20133
    - Recruiting
    - Research Site
  - Modena, Italy, 41124
    - Recruiting
    - Research Site
  - Naples, Italy, 80131
    - Recruiting
    - Research Site
  - Padova, Italy, 35128
    - Recruiting
    - Research Site
  - Pavia, Italy, 27100
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
Japan
- - Bunkyō City, Japan, 113-8431
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8519
    - Recruiting
    - Research Site
  - Chiba, Japan, 260-8717
    - Recruiting
    - Research Site
  - Chiba, Japan, 260-8677
    - Recruiting
    - Research Site
  - Chūōku, Japan, 104-0045
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 811-1395
    - Recruiting
    - Research Site
  - Hidaka-shi, Japan, 350-1298
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 734-8551
    - Recruiting
    - Research Site
  - Kashiwa, Japan, 277-8577
    - Recruiting
    - Research Site
  - Kobe, Japan, 650-0017
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Nagoya, Japan, 464-8681
    - Recruiting
    - Research Site
  - Nagoya, Japan, 466-8560
    - Recruiting
    - Research Site
  - Niigata, Japan, 951-8520
    - Recruiting
    - Research Site
  - Okayama, Japan, 700-8558
    - Recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Recruiting
    - Research Site
  - Osakasayama-shi, Japan, 589-8511
    - Recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-0375
    - Recruiting
    - Research Site
  - Sapporo, Japan, 060-8638
    - Recruiting
    - Research Site
  - Sendai, Japan, 980-8574
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-0023
    - Not yet recruiting
    - Research Site
  - Shiwa-gun, Japan, 028-3695
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
  - Yokohama, Japan, 236-0004
    - Recruiting
    - Research Site
Malaysia
- - George Town, Malaysia, 10450
    - Recruiting
    - Research Site
  - Johor Bahru, Malaysia, 81100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50586
    - Recruiting
    - Research Site
  - Kuala Selangor, Malaysia, 62250
    - Recruiting
    - Research Site
  - Kuching, Malaysia, 93586
    - Recruiting
    - Research Site
Philippines
- - Cebu City, Philippines, 6000
    - Withdrawn
    - Research Site
  - General Santos, Philippines, 9500
    - Not yet recruiting
    - Research Site
  - Iloilo City, Philippines, 5000
    - Not yet recruiting
    - Research Site
  - Manila, Philippines, 1008
    - Not yet recruiting
    - Research Site
  - Pasig, Philippines, 1605
    - Not yet recruiting
    - Research Site
  - Quezon City, Philippines, 1112
    - Withdrawn
    - Research Site
  - West San Juan City, Philippines, 1502
    - Not yet recruiting
    - Research Site
Poland
- - Bialystok, Poland, 15-027
    - Recruiting
    - Research Site
  - Bielsko-Biala, Poland, 43-300
    - Recruiting
    - Research Site
  - Bydgoszcz, Poland, 85-796
    - Recruiting
    - Research Site
  - Gliwice, Poland, 44-102
    - Recruiting
    - Research Site
  - Olsztyn, Poland, 10-228
    - Recruiting
    - Research Site
  - Piotrkow Trybunalski, Poland, 97-300
    - Recruiting
    - Research Site
  - Siedlce, Poland, 08-110
    - Recruiting
    - Research Site
  - Tomaszów Mazowiecki, Poland, 97-200
    - Withdrawn
    - Research Site
  - Warsaw, Poland, 02-781
    - Recruiting
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00927
    - Terminated
    - Research Site
South Korea
- - Goyang-si, South Korea, 410-769
    - Recruiting
    - Research Site
  - Gyeonggi-do, South Korea, 13620
    - Recruiting
    - Research Site
  - Incheon, South Korea, 21565
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 5505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 3722
    - Recruiting
    - Research Site
  - Suwon, South Korea, 16247
    - Recruiting
    - Research Site
Spain
- - Badalona, Spain, 08916
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08035
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08036
    - Recruiting
    - Research Site
  - Jaén, Spain, 23007
    - Recruiting
    - Research Site
  - Madrid, Spain, 28007
    - Recruiting
    - Research Site
  - Madrid, Spain, 28034
    - Recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Recruiting
    - Research Site
  - Valencia, Spain, 46026
    - Recruiting
    - Research Site
  - Valencia, Spain, 46014
    - Recruiting
    - Research Site
Taiwan
- - Changhua, Taiwan, 500
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 833401
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 404
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11217
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10300
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Chaing Mai, Thailand, 50200
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Withdrawn
    - Research Site
  - Lampang, Thailand, 52000
    - Recruiting
    - Research Site
  - Muang, Thailand, 22000
    - Recruiting
    - Research Site
  - Mueang, Thailand, 20000
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06230
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 6200
    - Recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07059
    - Recruiting
    - Research Site
  - Cordaleo, Turkey (Türkiye), 35575
    - Recruiting
    - Research Site
  - Eskişehir, Turkey (Türkiye), 26040
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34722
    - Recruiting
    - Research Site
  - Yenimahalle, Turkey (Türkiye), 06170
    - Recruiting
    - Research Site
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Recruiting
    - Research Site
  - Cambridge, United Kingdom, CB2 0XY
    - Recruiting
    - Research Site
  - Hampshire, United Kingdom, SO16 6YD
    - Recruiting
    - Research Site
  - Leeds, United Kingdom, LS9 7TF
    - Recruiting
    - Research Site
  - London, United Kingdom, EC1A 7BE
    - Recruiting
    - Research Site
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - Research Site
  - London, United Kingdom, SE1 9RT
    - Withdrawn
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - Research Site
  - Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    - Withdrawn
    - Research Site
  - Northwood, United Kingdom, HA6 2RN
    - Recruiting
    - Research Site
  - Sutton, United Kingdom, SM2 5PT
    - Recruiting
    - Research Site
  - Taunton, United Kingdom, TA1 5DA
    - Recruiting
    - Research Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - Research Site
- Arizona
  - Phoenix, Arizona, United States, 85028
    - Recruiting
    - Research Site
  - Prescott Valley, Arizona, United States, 86314
    - Suspended
    - Research Site
- Arkansas
  - Springdale, Arkansas, United States, 72762
    - Withdrawn
    - Research Site
- California
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90024
    - Suspended
    - Research Site
  - Orange, California, United States, 92868
    - Withdrawn
    - Research Site
  - San Francisco, California, United States, 94143
    - Suspended
    - Research Site
  - Santa Rosa, California, United States, 95403
    - Recruiting
    - Research Site
  - Whittier, California, United States, 90602
    - Recruiting
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Research Site
  - Colorado Springs, Colorado, United States, 80909
    - Recruiting
    - Research Site
  - Lone Tree, Colorado, United States, 80124
    - Recruiting
    - Research Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20037
    - Recruiting
    - Research Site
- Florida
  - Fort Myers, Florida, United States, 33901
    - Recruiting
    - Research Site
  - Gainesville, Florida, United States, 32610
    - Withdrawn
    - Research Site
  - Miami, Florida, United States, 33125
    - Withdrawn
    - Research Site
  - Palm Bay, Florida, United States, 32909
    - Recruiting
    - Research Site
  - West Palm Beach, Florida, United States, 33401
    - Recruiting
    - Research Site
- Illinois
  - Niles, Illinois, United States, 60714
    - Recruiting
    - Research Site
- Iowa
  - Des Moines, Iowa, United States, 50309
    - Recruiting
    - Research Site
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Research Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70817
    - Recruiting
    - Research Site
  - Shreveport, Louisiana, United States, 71101
    - Withdrawn
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21231
    - Not yet recruiting
    - Research Site
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - Research Site
  - Hyattsville, Maryland, United States, 20782
    - Recruiting
    - Research Site
  - Towson, Maryland, United States, 21204
    - Recruiting
    - Research Site
  - Upper Marlboro, Maryland, United States, 20774
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Research Site
  - Fairhaven, Massachusetts, United States, 02719
    - Recruiting
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48105
    - Recruiting
    - Research Site
  - Ann Arbor, Michigan, United States, 48109
    - Withdrawn
    - Research Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55417
    - Recruiting
    - Research Site
- Missouri
  - Columbia, Missouri, United States, 65211
    - Withdrawn
    - Research Site
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Research Site
  - St Louis, Missouri, United States, 63110
    - Withdrawn
    - Research Site
- New Jersey
  - East Brunswick, New Jersey, United States, 08816
    - Withdrawn
    - Research Site
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Research Site
  - New Brunswick, New Jersey, United States, 08901
    - Recruiting
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - Recruiting
    - Research Site
- New York
  - New York, New York, United States, 10075
    - Recruiting
    - Research Site
  - New York, New York, United States, 10065
    - Suspended
    - Research Site
  - Stony Brook, New York, United States, 11794
    - Recruiting
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Research Site
  - Winston-Salem, North Carolina, United States, 27157
    - Suspended
    - Research Site
- Ohio
  - Cleveland, Ohio, United States, 44106
    - Withdrawn
    - Research Site
- Oregon
  - Portland, Oregon, United States, 97213
    - Withdrawn
    - Research Site
  - Portland, Oregon, United States, 97239
    - Suspended
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Suspended
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15261
    - Recruiting
    - Research Site
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - Research Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Recruiting
    - Research Site
  - Sioux Falls, South Dakota, United States, 57104
    - Recruiting
    - Research Site
- Tennessee
  - Nashville, Tennessee, United States, 37212
    - Recruiting
    - Research Site
- Texas
  - Austin, Texas, United States, 78745
    - Recruiting
    - Research Site
  - Dallas, Texas, United States, 75251
    - Recruiting
    - Research Site
  - Flower Mound, Texas, United States, 75028
    - Withdrawn
    - Research Site
  - Houston, Texas, United States, 77030
    - Withdrawn
    - Research Site
  - Odessa, Texas, United States, 79761
    - Recruiting
    - Research Site
  - Tyler, Texas, United States, 75702
    - Withdrawn
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Recruiting
    - Research Site
  - West Jordan, Utah, United States, 84088
    - Recruiting
    - Research Site
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Research Site
  - Norfolk, Virginia, United States, 23502
    - Recruiting
    - Research Site
  - Richmond, Virginia, United States, 23230
    - Withdrawn
    - Research Site
- Washington
  - Spokane, Washington, United States, 99204
    - Withdrawn
    - Research Site
  - Tacoma, Washington, United States, 98405
    - Suspended
    - Research Site
  - Tacoma, Washington, United States, 98415
    - Suspended
    - Research Site
Vietnam
- - Da Nang, Vietnam, 550000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Huế, Vietnam, 530000
    - Recruiting
    - Research Site
  - Hà Nội, Vietnam, 100000
    - Recruiting
    - Research Site
  - Vinh, Vietnam, 460000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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:
1. LA-HNSCC that was resected before definitive cCRT
2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Arm Participants in this arm will receive volrustomig.	Drug: volrustomig volrustomig Other Names: MEDI5752
No Intervention: Observation Arm Patients in this arm will undergo observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population 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 BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.	Up to approximately 8 years
Landmark Progression-Free Survival (PFS) Rates 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 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.	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	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.	Up to approximately 8 years
Landmark Overall Survival (OS) Rates Time Frame: Up to approximately 8 years	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.	Up to approximately 8 years
Overall Survival (OS) in the unresected LA-HNSCC ITT population Time Frame: Up to approximately 8 years	OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.	Up to approximately 8 years
Progression Free Survival 2 (PFS2) Time Frame: Up to approximately 8 years	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.	Up to approximately 8 years
Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum Time Frame: Up to approximately 8 years	To investigate the immunogenicity of volrustomig.	Up to approximately 8 years
Participant-reported physical functioning Time Frame: Up to approximately 8 years	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.	Up to approximately 8 years
Participant-reported global health status (GHS)/quality of life (QoL) Time Frame: Up to approximately 8 years	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.	Up to approximately 8 years
Percentage of participants with Adverse Events Time Frame: Up to approximately 8 years	Adverse Events as assessed by Common Terminology Criteria for Adverse Events (CTCAE).	Up to approximately 8 years
Area under the curve (AUC) Time Frame: Up to approximately 8 years	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.	Up to approximately 8 years
Maximum plasma concentration of the drug (Cmax) Time Frame: Up to approximately 8 years	The concentration of Volrustomig in serum will be determined (Cmax will be derived).	Up to approximately 8 years
The time taken to reach the maximum concentration (Tmax) Time Frame: Up to approximately 8 years	The concentration of Volrustomig in serum will be determined (Tmax will be derived).	Up to approximately 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Chair: Robert Haddad, MD, Dana Farber Cancer Institute Massachusetts, USA
Study Chair: Lisa Licitra, MD, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Estimated)

April 18, 2028

Study Completion (Estimated)

September 12, 2030

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D798EC00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.

For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool .

Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Locally Advanced Head and Neck Squamous Cell Carcinoma

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