Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT02369874
Phase
PHASE3
Status
Completed

Conditions

  • Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN

Eligibility Criteria

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

Interventions

  • MEDI4736 — DRUG
    MEDI4736 Monotherapy
  • MEDI4736 + Tremelimumab — DRUG
    MEDI4736 + Tremelimumab combination therapy
  • Standard of Care — DRUG
    Standard of Care

Study Details

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.

Key Dates

Start date
Sep 9, 2015
Status verified
Jan 2021
Primary completion
Sep 10, 2018
Completion
Nov 13, 2020

Study Design

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

Arms

  • Experimental: MEDI4736
    MEDI4736 monotherapy
  • Experimental: MEDI4736 + Tremelimumab
    MEDI4736 + tremelimumab combination therapy
  • Active Comparator: Standard of Care
    Standard of Care

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: September 2015 to September 2018 (36 months) ]

Locations (23)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85711-
Research SiteFullertonCalifornia92835-3825-
Research SiteLos AngelesCalifornia90089-
Research SiteRedondo BeachCalifornia90277-
Research SiteStanfordCalifornia94305-
Research SiteDenverColorado80218-
Research SiteNewarkDelaware19713-
Research SiteMiami BeachFlorida33140-
Research SiteOrlandoFlorida32806-
Research SiteAtlantaGeorgia30322-
Research SiteEvanstonIllinois60201-1718-
Research SiteLexingtonKentucky40536-
Research SiteBostonMassachusetts02215-
Research SiteRochesterNew York14621-
Research SiteRochesterNew York14642-
Research SiteWinston-SalemNorth Carolina27157-
Research SitePittsburghPennsylvania15232-
Research SiteGermantownTennessee38138-
Research SiteNashvilleTennessee37232-
Research SiteDallasTexas75230-
Research SiteDallasTexas75246-
Research SiteMcAllenTexas78503-
Research SiteNorfolkVirginia23502-

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