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 ≥ 18 years of age.
• Have an ECOG performance status of 0 or 1.
• Have a history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome).
• Have a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment.
• Have a history of cirrhotic liver disease (Child-Pugh Class B or C).
• Have had a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic agent that has resolved per investigator or resolution of the radiologic findings).
• Have had prior treatment with MIRV or other FRα-targeting agents.
• Have spinal cord compression or clinically active CNS metastases.
• Have a history of other malignancy within 3 years prior to signing study consent.
• Have serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
  • Active hepatitis B or C infection (whether or not on active antiviral therapy).
  • HIV infection (unless subject meets inclusion criterion #9).
  • Active cytomegalovirus infection.
  • Any other concurrent infectious disease requiring IV treatment within 14 days prior to the first dose of study treatment.
• Have clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
• Have a history of clinically significant medical conditions, rapidly progressive disease, or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study treatment.
• Have a history of an allergic reaction or significant sensitivity to constituents of the study treatment (and its excipients) or other products in the same class.
• Have been previously treated with any investigational treatment within 28 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study.
• 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.
• Require the use of folate-containing supplements (e.g., folate deficiency).

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.