Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT and after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of mirvetuximab + carboplatin for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate and the patient will be declared a screen failure. Patients with BRCA mutations are not excluded from this trial and are allowed to receive standard of care maintenance therapy including bevacizumab and/or PARP inhibitors.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony biopsją wysokokażywi szpikowy rak jajnika
- •Zaawansowany nowotwór (stadium III lub IV) kwalifikujący się do chemioterapii przed operacją
- •Dostępna próbka tkanki guza do badania lub zgoda na pobranie nowej próbki
- •Dobry stan ogólny (skala 0 lub 1)
- •Tumor dodatni na znacznik FRα (ponad 75% komórek)
- •Prawidłowe wyniki badań krwi, wątroby i nerek
- •Gotowość do podpisania zgody i zastosowania się do wymogów badania
- •Kobiety w wieku rozrodczym: ujemny test ciąży i stosowanie skutecznej antykoncepcji
✗ Disqualifies
- •Wcześniejsza chemioterapia lub inne leczenie przeciwnowotworowe
- •Niska złośliwość guza lub inne typy raka jajnika (endometrialny, jasnokomórkowy, śluzowy)
- •Aktywne lub przewlekłe problemy z rogówką, historia przeszczepu rogówki lub niekontrolowana choroba oka
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 14, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (9)
University of Alabama at Birmingham Womens & Infants Center
Birmingham, United States
University of California San Francisco
San Francisco, United States
University of Minnesota - Masonic Cancer Center
Minneapolis, United States
Mayo Clinic
Rochester, United States
University of Mississippi Medical Center
Oxford, United States
Ohio State University
Columbus, United States
University of Oklahoma
Oklahoma City, United States
Allegheny Health Network
Pittsburgh, United States
University of Virginia
Richmond, United States
Trial contact
Rebecca Arend, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/15/2026.
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