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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 130 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Research Site
Birmingham, Alabama 35233

Research Site
Phoenix, Arizona 85028

Research Site
Fountain Valley, California 92708

Research Site
Los Angeles, California 90024

Research Site
Santa Rosa, California 95403

Research Site
Whittier, California 90602

Research Site
Aurora, Colorado 80045

Research Site
Colorado Springs, Colorado 80909

Research Site
Lone Tree, Colorado 80124

Research Site
Washington D.C., District of Columbia 20037

Research Site
Fort Myers, Florida 33901

Research Site
Palm Bay, Florida 32909

Research Site
West Palm Beach, Florida 33401

Research Site
Niles, Illinois 60714

Research Site
Des Moines, Iowa 50309

Research Site
Louisville, Kentucky 40202

Research Site
Baton Rouge, Louisiana 70817

Research Site
Baltimore, Maryland 21231

Research Site
Bethesda, Maryland 20817

Research Site
Hyattsville, Maryland 20782

Research Site
Towson, Maryland 21204

Research Site
Upper Marlboro, Maryland 20774

Research Site
Boston, Massachusetts 02215

Research Site
Fairhaven, Massachusetts 02719

Research Site
Ann Arbor, Michigan 48105

Research Site
Minneapolis, Minnesota 55417

Research Site
St Louis, Missouri 63110

Research Site
Hackensack, New Jersey 07601

Research Site
New York, New York 10065

Research Site
New York, New York 10075

Research Site
Stony Brook, New York 11794

Research Site
Charlotte, North Carolina 28204

Research Site
Winston-Salem, North Carolina 27157

Research Site
Pittsburgh, Pennsylvania 15261

Research Site
York, Pennsylvania 17403

Research Site
Sioux Falls, South Dakota 57104

Research Site
Sioux Falls, South Dakota 57105

Research Site
Nashville, Tennessee 37212

Research Site
Austin, Texas 78745

Research Site
Dallas, Texas 75251

Research Site
Odessa, Texas 79761

Research Site
Salt Lake City, Utah 84112

Research Site
West Jordan, Utah 84088

Research Site
Fairfax, Virginia 22031

Research Site
Norfolk, Virginia 23502

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.