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Single-Arm Phase II 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 who are Folate Receptor positive

Recruiting

The purpose of the study is to document the feasibility of undergoing surgery for cancer after receiving 3 cycles of neoadjuvant chemotherapy carboplatin and mirvetuximab soravtansine as first-line treatment in patients with advanced-stage ovarian cancer that are Folate Receptor alpha positive.

I'm interested

Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed high grade serous epithelial ovarian cancer
• stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy (before surgery)
• strenuous activity may be restricted but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for at least 4 months after the last dose
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• previously treated with a systemic anti-cancer therapy
• low-grade serous, endometrioid, clear cell, or mucinous cancer
• women who have active or chronic corneal (eye) disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision
• history of hepatitis B or C infection or human immunodeficiency virus (HIV) infection
• women who are pregnant or breastfeeding
• history of other cancer within 3 years prior
• significant heart, lung, liver disease

Cancer

Clinics and Surgery Center (CSC), Fallopian Tube, Ovarian Cancer, Primary Peritoneal Cancer

Britt Erickson - bkeric@umn.edu
Britt Erickson
PHASE2
STUDY00021464
See this study on ClinicalTrials.gov

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