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

Recruiting now · Phase 3

Conditions studied: Locally Advanced Head and Neck Squamous Cell Carcinoma

In brief

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).

Key facts

Study ID

NCT06129864

Run by

AstraZeneca

People needed

1145

Starts

2023-12-14

Expected to finish

2031-02-28

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Towson, Maryland, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Bethesda, Maryland, United States (enrolling)
• Research Site — Hyattsville, Maryland, United States (enrolling)
• Research Site — Upper Marlboro, Maryland, United States (enrolling)
• Research Site — Birmingham, Alabama, United States (enrolling)
• Research Site — Baltimore, Maryland, United States (enrolling)
• Research Site — Santa Rosa, California, United States (enrolling)
• Research Site — Whittier, California, United States (enrolling)
• Research Site — Fountain Valley, California, United States (enrolling)
• Research Site — Los Angeles, California, United States (enrolling)
• Research Site — Lone Tree, Colorado, United States (enrolling)
• Research Site — Washington D.C., District of Columbia, United States (enrolling)
• Research Site — Fort Myers, Florida, United States (enrolling)
• Research Site — San Francisco, California, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Palm Bay, Florida, United States (enrolling)
• Research Site — West Palm Beach, Florida, United States (enrolling)
• Research Site — Niles, Illinois, United States (enrolling)
• Research Site — Des Moines, Iowa, United States (enrolling)
• Research Site — Aurora, Colorado, United States (enrolling)
• Research Site — Louisville, Kentucky, United States (enrolling)
• Research Site — Baton Rouge, Louisiana, United States (enrolling)
• Research Site — Colorado Springs, Colorado, United States (enrolling)
• Research Site — Fairhaven, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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