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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Oct 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with advanced-stage ovarian, fallopian tube, or primary peritoneal cancer. Specifically, it is looking at the combination of two drugs, carboplatin and mirvetuximab soravtansine, given to patients who are starting their treatment with neoadjuvant chemotherapy (NACT). The trial aims to find out how well this combination works for patients whose tumors show a specific marker (FRα) and to see if it can be a safe and effective option before surgery. A total of 70 women will be included in the study, and participants will receive several cycles of the treatment before and after their surgery.

To be eligible for this trial, patients must have a confirmed diagnosis of high-grade serous ovarian cancer that is stage III or IV, and they should be suitable for receiving NACT. They will need to provide a sample of their tumor tissue for testing, and their cancer must show high levels of the FRα marker. Participants can expect to undergo multiple treatment cycles, followed by surgery and additional treatment. It’s important to note that women who are pregnant or breastfeeding, or who have certain other health issues, may not be eligible. This trial also allows for patients with specific genetic mutations to participate and receive standard care options.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.
• • Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy
• • Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity
• • Patients must have a performance status of 0 or 1.
• • Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in \>75% of cells
• * Patients must have adequate hematologic, liver and kidney functions defined as:
• • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/μL)
• • Platelet count ≥ 100 x 109/L (100,000/μL) without platelet transfusion in the prior 10 days
• • Hemoglobin ≥ 9.0 g/dL
• • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
• • Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN)
• • Serum albumin ≥ 2 g/dL
• • Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements
• • Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.8.6 while on MIRV and for at least 4 months after the last dose
• • WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV
• Exclusion Criteria:
• • Patients who have previously been treated with a systemic anti-cancer therapy
• • Patients with low-grade serous, endometrioid, clear cell, or mucinous histology
• • Patients with active or chronic corneal 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
• * Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
• • History of hepatitis B or C infection (whether or not on active antiviral therapy)
• • History of human immunodeficiency virus (HIV) infection
• • Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV
• • Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
• * Patients with clinically significant cardiac disease including, but not limited to, any of the following:
• • Myocardial infarction ≤ 6 months prior to first dose
• • Unstable angina pectoris
• • Uncontrolled congestive heart failure (New York Heart Association \> class II)
• • Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
• • Uncontrolled cardiac arrhythmias
• • Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
• • Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
• • Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
• • Patients requiring use of folate-containing supplements (eg, folate deficiency)
• • Patients with prior hypersensitivity to monoclonal antibodies (mAb)
• • Women who are pregnant or breastfeeding
• • Patients who received prior treatment with MIRV or other FRα-targeting agents
• • Patients with untreated or symptomatic central nervous system (CNS) metastases
• • Patients with a history of other malignancy within 3 years prior to enrollment Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible