Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT02319044
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - 96 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.

Key Dates

Start date
Apr 15, 2015
Status verified
Sep 2020
Primary completion
Sep 26, 2016
Completion
Jul 6, 2020

Study Design

Enrollment
267 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MEDI4736
    MEDI4736 monotherapy
  • Experimental: Tremelimumab
    Tremelimumab monotherapy
  • Experimental: MEDI4736 + Tremelimumab
    MEDI4736 + Tremelimumab combination therapy

Primary Outcome Measure

Objective Response Rate at 6 Months [ Time Frame: After 6 months ]

Locations (43)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35294-
Research SiteYumaArizona85364-
Research SiteLittle RockArkansas72205-
Research SiteDowneyCalifornia90241-
Research SiteDuarteCalifornia91010-3012-
Research SiteLa JollaCalifornia92093-
Research SiteLong BeachCalifornia90813-
Research SiteLos AngelesCalifornia90033-
Research SiteLos AngelesCalifornia90095-
Research SiteSan FranciscoCalifornia94115-
Research SiteAuroraColorado80045-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30322-
Research SiteAugustaGeorgia30912-
Research SiteMaconGeorgia31201-
Research SiteChicagoIllinois60637-
Research SiteEvanstonIllinois60201-
Research SiteLexingtonKentucky40536-0001-
Research SiteBaltimoreMaryland21201-
Research SiteBaltimoreMaryland21204-
Research SiteBostonMassachusetts02215-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48201-
Research SiteSouthfieldMichigan48075-
Research SiteRochesterMinnesota55905-0001-
Research SiteSt LouisMissouri63110-
Research SiteLebanonNew Hampshire03756-
Research SiteNew YorkNew York10032-
Research SiteStony BrookNew York11794-
Research SiteThe BronxNew York10467-
Research SiteDurhamNorth Carolina27705-
Research SiteWinston-SalemNorth Carolina27157-
Research SitePortlandOregon97239-
Research SiteBethlehemPennsylvania18015-
Research SitePittsburghPennsylvania15232-
Research SiteCharlestonSouth Carolina29425-
Research SiteKnoxvilleTennessee37909-
Research SiteNashvilleTennessee37232-
Research SiteArlingtonTexas76012-
Research SiteAustinTexas78701-
Research SiteDallasTexas75230-
Research SiteMorgantownWest Virginia26506-
Research SiteMilwaukeeWisconsin53226-

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