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Clinical Trials in the UK / NCT06129864
Recruiting Phase 3

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

NCT06129864 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2023-12-14
Last updated
2026-09-03

Condition(s) studied

Locally Advanced Head and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

volrustomig

volrustomig: volrustomig

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
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.

Primary outcome measure(s)

Trial sites (305)

FacilityCityRegionStatus
Research Site Birmingham Alabama Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Prescott Valley Arizona Active Not Recruiting
Research Site Springdale Arkansas Withdrawn
Research Site Fountain Valley California Recruiting
Research Site Los Angeles California Recruiting
Research Site Orange California Withdrawn
Research Site Santa Rosa California Recruiting
Research Site Whittier California Recruiting
Research Site Aurora Colorado Recruiting
Research Site Colorado Springs Colorado Recruiting
Research Site Lone Tree Colorado Recruiting
Research Site Washington D.C. District of Columbia Recruiting
Research Site Fort Myers Florida Recruiting
Research Site Gainesville Florida Withdrawn
Research Site Miami Florida Withdrawn
Research Site Palm Bay Florida Recruiting
Research Site West Palm Beach Florida Recruiting
Research Site Niles Illinois Recruiting
Research Site Des Moines Iowa Recruiting
Research Site Kansas City Kansas Completed
Research Site Louisville Kentucky Recruiting
Research Site Baton Rouge Louisiana Recruiting
Research Site Shreveport Louisiana Withdrawn
Research Site Baltimore Maryland Recruiting
Research Site Bethesda Maryland Recruiting
Research Site Hyattsville Maryland Recruiting
Research Site Towson Maryland Recruiting
Research Site Upper Marlboro Maryland Recruiting
Research Site Boston Massachusetts Recruiting
Research Site Fairhaven Massachusetts Recruiting
Research Site Ann Arbor Michigan Recruiting
Research Site Ann Arbor Michigan Withdrawn
Research Site Minneapolis Minnesota Recruiting
Research Site Columbia Missouri Withdrawn
Research Site St Louis Missouri Recruiting
Research Site St Louis Missouri Withdrawn
Research Site East Brunswick New Jersey Withdrawn
Research Site Hackensack New Jersey Recruiting
Research Site New Brunswick New Jersey Active Not Recruiting

+ 265 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06129864 on ClinicalTrials.gov ↗ ← All trials in the UK