A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects with FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The purpose of this study is to assess the safety and efficacy of neoadjuvant (treatment given before surgery) carboplatin and mirvetuximab soravtansine in participants with a specific type of epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States. Rush expects to enroll about 10 participants.

Participants will receive intravenous (IV) infusions of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years. Tumor tissue and blood samples will be collected during the study.

In order to participate you must meet the following criteria:

• Are female and 18 hears of age or older.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Have been judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy.
• Have been diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
• Have stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system.
• Have Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of >= 75% of viable tumor cells with moderate >= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central.
• Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.

You will be excluded from the study if any of the following criteria apply to you:

• Have endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.
• Have had previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.
• Have been previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin.
• Have following ocular history and/or concurrent disorders:
  • History of corneal transplantation.
  • Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery.
  • Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention.
  • Active or chronic clinically significant (>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy).
  • Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment.
  • Monocular vision with visual acuity in the worse eye, worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye).
• Have a history of other malignancy within 3 years prior to signing study consent.
  • Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.