A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
MedImmune LLC
Study ID
NCT02262741
Phase
PHASE1
Status
Completed

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI4736 — BIOLOGICAL
    MEDI4736 will be administered by IV infusion in combination with tremelimumab.
  • tremelimumab — BIOLOGICAL
    Tremelimumab will be administered by IV infusion in combination with MEDI4736.

Study Details

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

Key Dates

Start date
Oct 15, 2014
Status verified
Oct 2017
Primary completion
Sep 21, 2017
Completion
Sep 21, 2017

Study Design

Enrollment
71 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MEDI4736 + tremelimumab

Primary Outcome Measure

Number of subjects reporting adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]

Locations (21)

FacilityCityStateZIPSite coordinators
Research SiteScottsdaleArizona85258-
Research SiteLa JollaCalifornia92093-
Research SiteLos AngelesCalifornia90025-
Research SiteLos AngelesCalifornia90095-
Research SiteSan FranciscoCalifornia94143-
Research SiteAuroraColorado80045-
Research SiteNew HavenConnecticut06520-
Research SiteOrlandoFlorida32806-
Research SiteChicagoIllinois60611-
Research SiteFairwayKansas66205-
Research SiteNew OrleansLouisiana70112-
Research SiteBaltimoreMaryland21287-
Research SiteDetroitMichigan48201-
Research SiteMinneapolisMinnesota55455-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10065-
Research SitePortlandOregon97213-
Research SitePhiladelphiaPennsylvania19111-
Research SiteGreenvilleSouth Carolina29605-
Research SiteSan AntonioTexas78229-
Research SiteFairfaxVirginia22031-

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