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

NCT06129864

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions: volrustomig

Countries: United States, Austria, Belgium, Brazil, Canada, China, France, Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (306)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Prescott Valley, Arizona, United States
Springdale, Arkansas, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
Whittier, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Lone Tree, Colorado, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Palm Bay, Florida, United States
West Palm Beach, Florida, United States
Niles, Illinois, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Hyattsville, Maryland, United States
Towson, Maryland, United States
Upper Marlboro, Maryland, United States
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