AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
AstraZeneca
Study ID
NCT07218809
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • AZD5335 — DRUG
    antibody drug conjugate
  • Mirvetuximab Soravtansine (MIRV) — DRUG
    antibody drug conjugate
  • Paclitaxel — DRUG
    chemotherapy
  • Pegylated liposomal Doxorubicin (PLD) — DRUG
    chemotherapy
  • Topotecan — DRUG
    chemotherapy

Study Details

The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.

Key Dates

Start date
Dec 29, 2025
Status verified
Jan 2026
Primary completion
Nov 17, 2028
Completion
May 27, 2030

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD5335 in FRa-high cohort
    AZD5335 IV (intravenous) in FRa-high cohort
  • Active Comparator: Mirvetuximab Soravtansine (MIRV) in FRa-high cohort
    MIRV AIBW IV in FRa-high cohort
  • Experimental: AZD5335 in FRa-low cohort
    AZD5335 IV (intravenous) in FRa-low cohort
  • Active Comparator: Investigator´s choice chemotherapy in FRa-low cohort
    Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor

Primary Outcome Measure

Progression free Survival (PFS) [ Time Frame: Up to approximately 5 years ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Research SiteFort LauderdaleFlorida33316-
Research SiteJupiterFlorida33458-
Research SiteEvanstonIllinois60201-
Research SitePeoriaIllinois61637-
Research SiteUrbanaIllinois61801-
Research SiteTowsonMaryland21204-
Research SiteBurlingtonMassachusetts01805-
Research SiteWorcesterMassachusetts01655-
Research SiteMinneapolisMinnesota55404-
Research SiteOmahaNebraska68114-
Research SiteLas VegasNevada89106-
Research SiteThe BronxNew York10461-
Research SiteDaytonOhio45459-
Research SiteSylvaniaOhio43560-
Research SiteSan AntonioTexas78229-
Research SiteTylerTexas75702-
Research SiteFairfaxVirginia22031-

Find similar trials in Fort Lauderdale, FL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Research Site· Fort Lauderdale, FLResearch Site· Jupiter, FLResearch Site· Evanston, ILResearch Site· Peoria, ILResearch Site· Urbana, ILResearch Site· Towson, MD

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