Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)

Part of paid clinical trials in La Jolla, California.

Sponsor
Daiichi Sankyo
Study ID
NCT06819007
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Deruxtecan — DRUG
    T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
  • Bevacizumab — DRUG
    Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W

Study Details

This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \[IHC\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

Key Dates

Start date
Mar 19, 2025
Status verified
May 2026
Primary completion
Nov 1, 2028
Completion
Jan 31, 2032

Study Design

Enrollment
582 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm A
    Participants will receive T-DXd in combination with bevacizumab
  • Active Comparator: Treatment Arm B
    Participants will receive bevacizumab monotherapy

Primary Outcome Measure

Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population [ Time Frame: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Scripps ClinicLa JollaCalifornia92037-
Broward Health Medical CenterFort LauderdaleFlorida33316-
Jupiter Medical CenterJupiterFlorida33458-
Mount Sinai Medical CenterMiami BeachFlorida33140-
AdventHealth Cancer InstituteOrlandoFlorida32804-
Woman's Care FLSt. PetersburgFlorida33713-
Nancy N. & J.C Lewis Cancer & Research Pavillion- St. Josephs/ Candler Health SystemSavannahGeorgia31405-
Endeavor Health Evanston Kellogg Cancer Care CenterEvanstonIllinois60201-
Indiana UniversityIndianapolisIndiana46202-
Trials365 LLCShreveportLouisiana71103-
Greater Baltimore Medical CenterTowsonMaryland21204-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Trinity Health St. Joseph Mercy Ann ArborAnn ArborMichigan48106-
Corewell HealthGrand RapidsMichigan49503-
St. Vincent Gynecologic OncologyBillingsMontana59102-
Valley Health SystemParamusNew Jersey07652-
Columbia UniversityNew YorkNew York10032-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
UNC HospitalChapel HillNorth Carolina27599-
Miami Valley Hospital SouthCentervilleOhio45459-
Legacy Medical Group Gynecologic OncologyPortlandOregon97210-
Providence Cancer Center OncologyPortlandOregon97213-
St. Lukes University Health NetworkBethlehemPennsylvania18015-
Ann B Barshinger Cancer InstituteLancasterPennsylvania17601-
Avera Medical Group GynecologicSioux FallsSouth Dakota57105-
Sarah Cannon Research Institute (Oncology Associates of Oregon PC)NashvilleTennessee37203-

Find similar trials in La Jolla, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Scripps Clinic· La Jolla, CABroward Health Medical Center· Fort Lauderdale, FLJupiter Medical Center· Jupiter, FLMount Sinai Medical Center· Miami Beach, FLAdventHealth Cancer Institute· Orlando, FLWoman's Care FL· St. Petersburg, FL

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