Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
AstraZeneca
Study ID
NCT02551159
Phase
PHASE3
Status
Completed

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

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

Interventions

  • MEDI4736 — BIOLOGICAL
    Anti-PD-L1 antibody
  • Tremelimumab — BIOLOGICAL
    Anti-CTLA-4 Antibody
  • MEDI4736+Tremelimumab — BIOLOGICAL
  • Cetuximab — BIOLOGICAL
    Monoclonal Antibody
  • 5-fluorouracil (5FU) — DRUG
    Chemotherapy Agent
  • Cisplatin — DRUG
    Chemotherapy agent
  • Carboplatin — DRUG
    Chemotherapy Agent

Study Details

This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

Key Dates

Start date
Oct 15, 2015
Status verified
Sep 2021
Primary completion
Jul 6, 2020
Completion
May 21, 2021

Study Design

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

Arms

  • Experimental: Monotherapy
    MEDI4736 monotherapy.
  • Experimental: Combination Therapy
    MEDI4736+Tremelimumab combination therapy
  • Active Comparator: Standard of Care
    Standard of Care treatment

Primary Outcome Measure

Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) [ Time Frame: From date of randomization until time of final analysis, an average of approximately 4 years ]

Locations (19)

FacilityCityStateZIPSite coordinators
Research SiteAuroraColorado80045-
Research SiteWashington D.C.District of Columbia20007-
Research SiteFort MyersFlorida33916-
Research SiteSt. PetersburgFlorida33705-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60637-
Research SiteBaltimoreMaryland21201-
Research SiteBaltimoreMaryland21231-
Research SiteBostonMassachusetts02215-
Research SiteMorristownNew Jersey07960-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10065-
Research SiteChapel HillNorth Carolina27599-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteClevelandOhio44115-
Research SiteColumbusOhio43210-
Research SiteNashvilleTennessee37203-

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By research site
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