Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

Part of paid clinical trials in Foothill Ranch, California.

Sponsor
AstraZeneca
Study ID
NCT03737643
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Advanced Ovarian Cancer

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
  • Durvalumab — DRUG
    Durvalumab by intravenous infusion
  • Olaparib — DRUG
    Olaparib tablets
  • Placebo olaparib — DRUG
    Placebo tablets to match olaparib
  • Durvalumab placebo — DRUG
    Matching placebo for intravenous infusion
  • Carboplatin+Paclitaxel — DRUG
    Standard of care chemotherapy

Study Details

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

Key Dates

Start date
Jan 4, 2019
Status verified
May 2026
Primary completion
Mar 17, 2025
Completion
Dec 23, 2026

Study Design

Enrollment
1,407 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1
    Platinum-based chemotherapy in combination with bevacizumab and durvalumab placebo (saline IV infusion) followed by maintenance bevacizumab, durvalumab placebo (saline IV infusion) and olaparib placebo (tablets).
  • Experimental: Arm 2
    Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo.
  • Experimental: Arm 3
    Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib.
  • Experimental: tBRCAm cohort
    Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib. Bevacizumab is optional according to local practice.

Primary Outcome Measure

Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set [ Time Frame: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months ]

Locations (26)

FacilityCityStateZIPSite coordinators
Research SiteFoothill RanchCalifornia92610-
Research SiteLos AngelesCalifornia90095-
Research SiteOrangeCalifornia92868-3298-
Research SiteSan FranciscoCalifornia94158-
Research SiteTampaFlorida33612-
Research SiteAugustaGeorgia30912-
Research SiteHinsdaleIllinois60521-
Research SiteIndianapolisIndiana46202-
Research SiteTowsonMaryland21204-
Research SiteDetroitMichigan48202-
Research SiteSpringfieldMissouri65807-
Research SiteMiddletownNew Jersey07748-
Research SiteMontvaleNew Jersey07645-
Research SiteAlbanyNew York12208-
Research SiteNew YorkNew York10065-
Research SiteUniondaleNew York11553-
Research SiteDurhamNorth Carolina27710-
Research SiteClevelandOhio44195-
Research SiteDaytonOhio45429-
Research SiteHilliardOhio43026-
Research SiteTulsaOklahoma74134-
Research SiteLancasterPennsylvania17601-
Research SitePhiladelphiaPennsylvania19104-
Research SitePhiladelphiaPennsylvania19107-5097-
Research SitePittsburghPennsylvania15224-
Research SiteSalt Lake CityUtah84112-

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