Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
MedImmune LLC
Study ID
NCT02117219
Phase
PHASE1
Status
Completed

Conditions

  • Myelodysplastic Syndrome

Eligibility Criteria

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

Interventions

  • MEDI4736 Evaluate MEDI4736 in MDS — BIOLOGICAL
    MEDI4736 will be administered by IV infusion
  • VIDAZA — DRUG
    VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy
  • tremelimumab — BIOLOGICAL
    tremelimumab will be administered by IV infusion

Study Details

This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents

Key Dates

Start date
May 20, 2014
Status verified
May 2019
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019

Study Design

Enrollment
67 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MEDI4736 Evaluate MEDI4736 in MDS
    Evaluate MEDI4736 monotherapy and MEDI4736 in combination with azacitidine after monotherapy progression in MDS
  • Experimental: MEDI4736 + tremelimumab
    Evaluate MEDI4736 in combination with tremelimumab
  • Experimental: MEDI4736 + tremelimumab + azacitidine
    Evaluate MEDI4736 in combination with tremelimumab and azacitidine

Primary Outcome Measure

Subject's safety where no more than one out of six subjects experience DLTs at a given dose [ Time Frame: 180 days ]

Locations (16)

FacilityCityStateZIPSite coordinators
Research SiteScottsdaleArizona85259-
Research SiteLos AngelesCalifornia90095-
Research SiteNew HavenConnecticut06520-8063-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60637-
Research SiteBaltimoreMaryland21201-
Research SiteBostonMassachusetts02215-
Research SiteDetroitMichigan48201-
Research SiteRochesterMinnesota55905-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10065-
Research SiteGreenvilleSouth Carolina29601-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78229-
Research SiteMilwaukeeWisconsin53226-

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