A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
MedImmune LLC
Study ID
NCT02000947
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 101 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI4736 — DRUG
    MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).
  • Tremelimumab — DRUG
    Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
  • tremelimumab — DRUG
    Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).

Study Details

The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).

Key Dates

Start date
Oct 25, 2013
Status verified
Oct 2019
Primary completion
Sep 17, 2019
Completion
Sep 17, 2019

Study Design

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

Arms

  • Experimental: Dose Escalation
    MEDI4736 and tremelimumab received by intravenous infusion.
  • Experimental: Arm A
    Medi4736 and tremelimumab received by intravenous infusion
  • Experimental: Arm B
    MEDI4736 and tremelimumab received by intravenous infusion
  • Experimental: Arm C
    MEDI4736 and tremelimumab received by intravenous infursion

Primary Outcome Measure

Number of subjects reporting adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]

Locations (28)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35294-3300-
Research SiteTucsonArizona85715-
Research SiteLos AngelesCalifornia90025-
Research SiteLos AngelesCalifornia90095-
Research SiteSan FranciscoCalifornia94158-
Research SiteAuroraColorado80045-
Research SiteNew HavenConnecticut06510-
Research SiteNewarkDelaware19713-
Research SiteTampaFlorida33612-
Research SiteIndianapolisIndiana46202-
Research SiteBaltimoreMaryland21287-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48201-
Research SiteSt LouisMissouri63110-
Research SiteLebanonNew Hampshire03756-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SiteHuntersvilleNorth Carolina28078-
Research SiteColumbusOhio43210-
Research SitePortlandOregon97213-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77521-
Research SiteTylerTexas75702-
Research SiteFairfaxVirginia22031-
Research SiteSeattleWashington98109-
Research SiteMorgantownWest Virginia26506-

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