Recruiting

Phase 3

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

Sponsor:

AstraZeneca

Code:

NCT06129864

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

volrustomig

Study Details

Brief 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).

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Study ID

NCT06129864

Start date

Dec 14, 2023

Status verified date

Sep, 2026

Completion date

Feb 28, 2031

Anticipated

Primary completion date

Apr 17, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1145 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study Arm

Participants in this arm will receive volrustomig.

no intervention: Observation Arm

Patients in this arm will undergo observation.

Interventions

volrustomig

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 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

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Birmingham, Alabama, United States, 35233

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Phoenix, Arizona, United States, 85028

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Fountain Valley, California, United States, 92708

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Los Angeles, California, United States, 90024

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Santa Rosa, California, United States, 95403

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Whittier, California, United States, 90602

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Aurora, Colorado, United States, 80045

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Colorado Springs, Colorado, United States, 80909

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Lone Tree, Colorado, United States, 80124

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Washington D.C., District of Columbia, United States, 20037

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Fort Myers, Florida, United States, 33901

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Palm Bay, Florida, United States, 32909

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West Palm Beach, Florida, United States, 33401

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Niles, Illinois, United States, 60714

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Des Moines, Iowa, United States, 50309

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Louisville, Kentucky, United States, 40202

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Baton Rouge, Louisiana, United States, 70817

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Baltimore, Maryland, United States, 21231

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Bethesda, Maryland, United States, 20817

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Hyattsville, Maryland, United States, 20782

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Towson, Maryland, United States, 21204

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Upper Marlboro, Maryland, United States, 20774

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Boston, Massachusetts, United States, 02215

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Fairhaven, Massachusetts, United States, 02719

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Ann Arbor, Michigan, United States, 48105

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Minneapolis, Minnesota, United States, 55417

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St Louis, Missouri, United States, 63110

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Hackensack, New Jersey, United States, 07601

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New York, New York, United States, 10065

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New York, New York, United States, 10075

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Stony Brook, New York, United States, 11794

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Charlotte, North Carolina, United States, 28204

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Winston-Salem, North Carolina, United States, 27157

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Pittsburgh, Pennsylvania, United States, 15261

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York, Pennsylvania, United States, 17403

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Sioux Falls, South Dakota, United States, 57104

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Sioux Falls, South Dakota, United States, 57105

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Nashville, Tennessee, United States, 37212

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Austin, Texas, United States, 78745

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Dallas, Texas, United States, 75251

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Odessa, Texas, United States, 79761

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Salt Lake City, Utah, United States, 84112

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West Jordan, Utah, United States, 84088

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Fairfax, Virginia, United States, 22031

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Norfolk, Virginia, United States, 23502

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Calgary, Alberta, Canada, T2N 5G2

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Edmonton, Alberta, Canada, T6G 1Z2

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Kelowna, British Columbia, Canada, V1Y 5L3

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Kingston, Ontario, Canada, K7L 2V7

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London, Ontario, Canada, N6A 5W9

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Toronto, Ontario, Canada, M4N 3M5

Research Site

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Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

AstraZeneca

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-03.