Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT04269200
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Endometrial Neoplasms

Eligibility Criteria

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

Interventions

  • olaparib — DRUG
    Olaparib tablets
  • durvalumab — BIOLOGICAL
    Durvalumab by intravenous infusion
  • durvalumab placebo — DRUG
    Matching placebo for intravenous infusion
  • olaparib placebo — DRUG
    Placebo tablets to match olaparib
  • Carboplatin — DRUG
    Standard of care chemotherapy
  • Paclitaxel — DRUG
    Standard of care chemotherapy

Study Details

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

Key Dates

Start date
May 5, 2020
Status verified
May 2026
Primary completion
Jul 8, 2024
Completion
Apr 1, 2027

Study Design

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

Arms

  • Active Comparator: Arm A (control)
    Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).
  • Experimental: Arm B (durvalumab+placebo)
    Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo
  • Experimental: Arm C (durvalumab+olaparib)
    Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.

Primary Outcome Measure

Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments [ Time Frame: At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months ]

Locations (50)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteConcordCalifornia94520-2278-
Research SiteLa JollaCalifornia92093-
Research SiteSan FranciscoCalifornia94158-
Research SiteSanta BarbaraCalifornia93105-
Research SiteAuroraColorado80012-
Research SiteFort LauderdaleFlorida33316-
Research SiteTampaFlorida33612-
Research SiteSavannahGeorgia31404-
Research SiteHonoluluHawaii96826-
Research SiteArlington HeightsIllinois60005-
Research SiteChicagoIllinois60637-
Research SiteIndianapolisIndiana46237-
Research SiteLouisvilleKentucky40207-
Research SiteBaton RougeLouisiana70817-
Research SiteBostonMassachusetts02111-
Research SiteSaint PaulMinnesota55125-
Research SiteJacksonMississippi39216-
Research SiteLebanonNew Hampshire03756-
Research SiteCamdenNew Jersey08103-
Research SiteParamusNew Jersey07652-
Research SiteNew YorkNew York10011-
Research SiteNew YorkNew York10029-
Research SitePinehurstNorth Carolina28374-
Research SiteClevelandOhio44109-
Research SiteClevelandOhio44124-
Research SiteDaytonOhio45459-
Research SiteOklahoma CityOklahoma73104-
Research SiteTulsaOklahoma74134-
Research SiteEugeneOregon97401-
Research SiteTigardOregon97223-
Research SitePittsburghPennsylvania15224-
Research SiteProvidenceRhode Island02905-
Research SiteSioux FallsSouth Dakota57105-
Research SiteChattanoogaTennessee37403-
Research SiteGermantownTennessee38138-
Research SiteKnoxvilleTennessee37920-
Research SiteBedfordTexas76022-
Research SiteDallasTexas75231-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78240-
Research SiteSugar LandTexas77479-
Research SiteTylerTexas75702-
Research SiteWebsterTexas77598-
Research SiteFairfaxVirginia22031-
Research SiteNorfolkVirginia23502-
Research SiteSeattleWashington98195-
Research SiteMorgantownWest Virginia26505-
Research SiteMadisonWisconsin53792-
Research SiteMilwaukeeWisconsin53226-

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