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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06129864
Phase
PHASE3
Status
Recruiting
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Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • volrustomig — DRUG
    volrustomig

Study Details

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 Dates

Start date
Dec 14, 2023
Status verified
May 2026
Primary completion
Apr 18, 2028
Completion
Sep 12, 2030

Study Design

Enrollment
1,145 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Arm
    Participants in this arm will receive volrustomig.
  • No Intervention: Observation Arm
    Patients in this arm will undergo observation.

Primary Outcome Measure

Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors [ Time Frame: Up to approximately 8 years ]

Central Contacts

Locations (70)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SitePhoenixArizona85028-
Research SitePrescott ValleyArizona86314-
Research SiteSpringdaleArkansas72762-
Research SiteFountain ValleyCalifornia92708-
Research SiteLos AngelesCalifornia90024-
Research SiteOrangeCalifornia92868-
Research SiteSan FranciscoCalifornia94143-
Research SiteSanta RosaCalifornia95403-
Research SiteWhittierCalifornia90602-
Research SiteAuroraColorado80045-
Research SiteColorado SpringsColorado80909-
Research SiteLone TreeColorado80124-
Research SiteWashington D.C.District of Columbia20037-
Research SiteFort MyersFlorida33901-
Research SiteGainesvilleFlorida32610-
Research SiteMiamiFlorida33125-
Research SitePalm BayFlorida32909-
Research SiteWest Palm BeachFlorida33401-
Research SiteNilesIllinois60714-
Research SiteDes MoinesIowa50309-
Research SiteKansas CityKansas66160-
Research SiteLouisvilleKentucky40202-
Research SiteBaton RougeLouisiana70817-
Research SiteShreveportLouisiana71101-
Research SiteBaltimoreMaryland21231-
Research SiteBethesdaMaryland20817-
Research SiteHyattsvilleMaryland20782-
Research SiteTowsonMaryland21204-
Research SiteUpper MarlboroMaryland20774-
Research SiteBostonMassachusetts02215-
Research SiteFairhavenMassachusetts02719-
Research SiteAnn ArborMichigan48105-
Research SiteAnn ArborMichigan48109-
Research SiteMinneapolisMinnesota55417-
Research SiteColumbiaMissouri65211-
Research SiteSt LouisMissouri63110-
Research SiteSt LouisMissouri63110-
Research SiteEast BrunswickNew Jersey08816-
Research SiteHackensackNew Jersey07601-
Research SiteNew BrunswickNew Jersey08901-
Research SiteAlbuquerqueNew Mexico87108-
Research SiteNew YorkNew York10065-
Research SiteNew YorkNew York10075-
Research SiteStony BrookNew York11794-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteClevelandOhio44106-
Research SitePortlandOregon97213-
Research SitePortlandOregon97239-
Research SitePhiladelphiaPennsylvania19107-
Research SitePittsburghPennsylvania15261-
Research SiteYorkPennsylvania17403-
Research SiteSioux FallsSouth Dakota57104-
Research SiteSioux FallsSouth Dakota57105-
Research SiteNashvilleTennessee37212-
Research SiteAustinTexas78745-
Research SiteDallasTexas75251-
Research SiteFlower MoundTexas75028-
Research SiteHoustonTexas77030-
Research SiteOdessaTexas79761-
Research SiteTylerTexas75702-
Research SiteSalt Lake CityUtah84112-
Research SiteWest JordanUtah84088-
Research SiteFairfaxVirginia22031-
Research SiteNorfolkVirginia23502-
Research SiteRichmondVirginia23230-
Research SiteSpokaneWashington99204-
Research SiteTacomaWashington98405-
Research SiteTacomaWashington98415-

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