Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Summary

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate 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 (FIGO) III-IV FRα-expressing serous EOC. Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles.

To be included in GOG #3115, participants must be / have:  

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 
• Be judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy
• Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer
• Stage III or IV disease
• Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of ≥ 75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria

To be included in GOG #3115, participants must not be / have: 

• Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor
• Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis
• 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
• Participants with the 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)
  • History of other malignancy within 3 years prior to signing study consent

Keywords

 ADC; Cancer; Chemotherapy; Gynecologic oncology; Ovarian cancer