Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03847428
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 150 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab IV (intravenous)
  • Bevacizumab — DRUG
    Bevacizumab IV (intravenous)
  • Placebo — OTHER
    Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking

Study Details

A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

Key Dates

Start date
Apr 29, 2019
Status verified
Mar 2026
Primary completion
May 29, 2026
Completion
May 31, 2027

Study Design

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

Arms

  • Experimental: Arm A
    Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
  • Experimental: Arm B
    Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
  • Placebo Comparator: Arm C
    Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)

Primary Outcome Measure

Recurrence-free survival (RFS) for Arm A vs Arm C [ Time Frame: Up to 49 months after first patient randomized ]

Locations (34)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SiteMobileAlabama36604-
Research SitePhoenixArizona85054-
Research SiteCosta MesaCalifornia92627-
Research SiteLa JollaCalifornia92093-0698-
Research SiteLong BeachCalifornia90806-
Research SiteOrangeCalifornia92868-
Research SiteSacramentoCalifornia95817-
Research SiteWashington D.C.District of Columbia20007-
Research SiteMiamiFlorida33176-
Research SiteTampaFlorida33606-
Research SiteHonoluluHawaii96819-
Research SiteChicagoIllinois60637-
Research SiteWestwoodKansas66205-
Research SiteLouisvilleKentucky40206-
Research SiteShreveportLouisiana71103-
Research SiteDetroitMichigan48201-
Research SiteGrand RapidsMichigan49503-
Research SiteRochesterMinnesota55905-
Research SiteOmahaNebraska68198-
Research SiteNew BrunswickNew Jersey08903-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteNew YorkNew York10021-
Research SiteStony BrookNew York11794-
Research SiteDurhamNorth Carolina27710-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteClevelandOhio44106-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15212-
Research SiteSpartanburgSouth Carolina29303-
Research SiteKnoxvilleTennessee37916-
Research SiteMemphisTennessee38104-
Research SiteDallasTexas75216-
Research SiteMadisonWisconsin53715-

Find similar trials in Birmingham, AL

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By specialty
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By research site
Research Site· Birmingham, ALResearch Site· Mobile, ALResearch Site· Phoenix, AZResearch Site· Costa Mesa, CAResearch Site· La Jolla, CAResearch Site· Long Beach, CA

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