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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

RecruitingPhase 3

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)

Who can join

Ages 18 to 130 · All sexes

Full 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.

About the study

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).

What is being tested

Sponsor: AstraZeneca · Participants: 1,145 · Started: Dec 14, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06129864

Locations in the U.S.

AlabamaResearch Site, Birmingham
ArizonaResearch Site, Phoenix
CaliforniaResearch Site, Fountain Valley
Research Site, Los Angeles
Research Site, Santa Rosa
Research Site, Whittier
ColoradoResearch Site, Aurora
Research Site, Colorado Springs
Research Site, Lone Tree
District of ColumbiaResearch Site, Washington D.C.
FloridaResearch Site, Fort Myers
Research Site, Palm Bay
Research Site, West Palm Beach
IllinoisResearch Site, Niles
IowaResearch Site, Des Moines
KentuckyResearch Site, Louisville
LouisianaResearch Site, Baton Rouge
MarylandResearch Site, Baltimore
Research Site, Bethesda
Research Site, Hyattsville
Research Site, Towson
Research Site, Upper Marlboro
MassachusettsResearch Site, Boston
Research Site, Fairhaven
MichiganResearch Site, Ann Arbor
MinnesotaResearch Site, Minneapolis
MissouriResearch Site, St Louis
New JerseyResearch Site, Hackensack
New YorkResearch Site, New York
Research Site, New York
Research Site, Stony Brook
North CarolinaResearch Site, Charlotte
Research Site, Winston-Salem
PennsylvaniaResearch Site, Pittsburgh
Research Site, York
South DakotaResearch Site, Sioux Falls
Research Site, Sioux Falls
TennesseeResearch Site, Nashville
TexasResearch Site, Austin
Research Site, Dallas
Research Site, Odessa
UtahResearch Site, Salt Lake City
Research Site, West Jordan
VirginiaResearch Site, Fairfax
Research Site, Norfolk

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.