Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT02516241
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer

Key Dates

Start date
Nov 2, 2015
Status verified
Apr 2026
Primary completion
Jan 27, 2020
Completion
Dec 31, 2026

Study Design

Enrollment
1,126 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy
    MEDI4736 (Durvalumab) + Tremelimumab
  • Experimental: Monotherapy
    MEDI4736 (Durvalumab)
  • Active Comparator: Standard of Care
    Standard of Care Chemotherapy Treatment

Primary Outcome Measure

To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set [ Time Frame: From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years). ]

Locations (16)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90095-
Research SiteStanfordCalifornia94305-
Research SiteAuroraColorado80045-
Research SiteNew HavenConnecticut06520-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30322-
Research SiteLouisvilleKentucky40202-
Research SiteBostonMassachusetts02215-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48201-
Research SiteOmahaNebraska68130-
Research SiteNew YorkNew York10021-
Research SiteNew YorkNew York10029-
Research SiteMemphisTennessee38120-
Research SiteNashvilleTennessee37203-
Research SiteSeattleWashington98101-

Find similar trials in Los Angeles, CA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Research Site· Los Angeles, CAResearch Site· Stanford, CAResearch Site· Aurora, COResearch Site· New Haven, CTResearch Site· Tampa, FLResearch Site· Atlanta, GA

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