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OncoMatch/Clinical Trials/NCT07218809

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

Is NCT07218809 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for epithelial ovarian cancer.

Phase 3RecruitingAstraZenecaNCT07218809Data as of Jun 2026Location: International · 21 countries

Treatment: AZD5335 · Mirvetuximab Soravtansine (MIRV) · Paclitaxel · Pegylated liposomal Doxorubicin (PLD) · TopotecanThe 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Mirvetuximab Soravtansine (MIRV)

Chemotherapy

PaclitaxelPegylated liposomal Doxorubicin (PLD)Topotecan

Other

AZD5335

Cancer type

Ovarian Cancer

Biomarker criteria

Allowed: BRCA1 mutation

Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication, precaution or intolerance.

Allowed: BRCA2 mutation

Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication, precaution or intolerance.

Demographics

Female only

Prior therapy

Max 3 prior lines
Min 1 prior line

Must have received: platinum-based chemotherapy

Participants must have platinum-resistant disease

Cannot have received: FRα-targeted therapy (mirvetuximab soravtansine)

Prior treatment with any FRα-targeted therapy, including MIRV

Cannot have received: TOP1i antibody-drug conjugate

Prior treatment with any TOP1i ADC

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Research Site · Fort Lauderdale, Florida
  • Research Site · Jupiter, Florida
  • Research Site · Evanston, Illinois
  • Research Site · Peoria, Illinois
  • Research Site · Urbana, Illinois

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07218809 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior FRα-targeted therapy, TOP1i antibody-drug conjugate disqualifies patients from enrollment.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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