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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
Status: Recruiting
The purpose of this study is to look at the safety and efficacy of neoadjuvant ( before surgery) carboplatin and mirvetuximab soravtansine for women who have folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). Mirvetuximab Soravtansine (MIRV) is an investigational drug designed to selectively kill cancer cells. All participants will receive an intravenous infusion of MIRV in combination with carboplatin for up to 6 - 9 Cycles
Sex: Female
Age Group: 18 years and over
Inclusion Criteria:
• may not be able to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• have been 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
• previous clinical diagnosis of noninfectious interstitial lung disease
• eye conditions requiring ongoing treatment/monitoring
• history of another malignancy within past 3 years
Interventions:
Drug: Bevacizumab, Drug: Carboplatin, Drug: Mirvetuximab Soravtansine
Conditions:
Cancer
Keywords:
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Study Contact: Stephanie Knutson - stephannie.knutson@fairview.org
Principal Investigator: Colleen Rivard
Phase: PHASE2
IRB Number: MMCORC092
See this study on ClinicalTrials.gov