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Study of Volrustomig for Locally Advanced Head and Neck Squamous Cell Carcinoma

This study is looking at a drug called volrustomig for people with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This is a type of cancer that has not spread to other parts of the body and cannot be removed by surgery. You might be able to join if you are 18 years or older, have LA-HNSCC that has been confirmed by a doctor, and have already had chemotherapy and radiation treatment without your cancer getting worse. The main goal is to see if volrustomig can help prevent the cancer from growing or spreading compared to just being observed. The study is currently unclear on its recruitment status and plans to enroll about 1145 participants.

Study design
This study is comparing volrustomig to observation in about 1145 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Progression-Free Survival (PFS) for up to approximately 8 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06129864

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~1,145 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:volrustomig

At a glance

Recruiting sites
251 of 306 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Measured over Up to approximately 8 years

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

306 sites across 56 states
China40
Japan26
Germany14
India14
Brazil13
United Kingdom12
Hungary11
Poland9

Study leadership

  • Robert Haddad, MD · STUDY_CHAIR · Dana Farber Cancer Institute Massachusetts, USA
  • Lisa Licitra, MD · STUDY_CHAIR · Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Participants with any of the following:
Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.

What this trial measures

  • Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumorsUp to approximately 8 years

    PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.