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OncoMatch/Clinical Trials/NCT07059845

A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer

Is NCT07059845 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Mirvetuximab Soravtansine and Bevacizumab for ovarian cancer.

Phase 2RecruitingAbbVieNCT07059845Data as of Sep 2026Location: International · 8 countries

Treatment: Mirvetuximab Soravtansine · Bevacizumab · CarboplatinOvarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay. Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world. Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Mirvetuximab SoravtansineBevacizumab

Chemotherapy

Carboplatin

Cancer type

Ovarian Cancer

Biomarker criteria

Required: FOLR1 expression (≥ 50% of viable tumor cells with ≥ 2+ staining intensity)

FRα-expression in ≥ 50% of viable tumor cells with ≥ 2+ staining intensity

Required: BRCA1 wild-type

Participants with BRCA wild-type will need to have a local HRD test result available

Required: BRCA2 wild-type

Participants with BRCA wild-type will need to have a local HRD test result available

Disease stage

Required: Stage FIGO STAGE III, FIGO STAGE IV (FIGO)

Metastatic disease required

Grade: high-grade

FIGO Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Female only

Prior therapy

Max 2 prior lines

Must have received: platinum-based chemotherapy

Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy

Cannot have received: mirvetuximab soravtansine (mirvetuximab soravtansine)

Participants who received prior treatment with mirvetuximab soravtansine

Cannot have received: FRα-targeting agent

Participants who received prior treatment with any FRα-targeting agent

Cannot have received: PARP inhibitor

Participants who received prior treatment with Poly(ADP-ribose) polymerase inhibitor (PARPi)

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

US trial sites

  • UC San Diego Health - Moores Cancer Center /ID# 277574 · La Jolla, California
  • Sansum Clinic - Solvang /ID# 277712 · Solvang, California
  • University of Florida College of Medicine /ID# 278348 · Gainesville, Florida
  • Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623 · Orlando, Florida
  • Florida Cancer Specialists - North /ID# 278626 · St. Petersburg, Florida

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Frequently asked questions

Is NCT07059845 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior mirvetuximab soravtansine, FRα-targeting agent, PARP inhibitor disqualifies patients from enrollment.

Does this trial require FOLR1?

Yes, FOLR1 expression is a required biomarker for enrollment.

Does this trial require BRCA1?

Yes, BRCA1 wild-type is a required biomarker for enrollment.

Does this trial require BRCA2?

Yes, BRCA2 wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage FIGO STAGE III or FIGO STAGE IV is required (metastatic disease required).

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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