Carboplatin and Mirvetuximab for Advanced Ovarian Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a combination treatment using carboplatin and mirvetuximab soravtansine in patients with advanced-stage ovarian cancer who are receiving neoadjuvant chemotherapy. The study focuses on patients with high-grade serous epithelial ovarian cancer that over-expresses the folate receptor α (FRα). Participants will receive a specific regimen of chemotherapy and targeted therapy before undergoing surgery, with the aim of improving treatment outcomes. The trial will include 70 patients and assess the feasibility and efficacy of this treatment approach.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham Womens & Infants Center
  Birmingham, Alabama, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• University of Minnesota - Masonic Cancer Center
  Minneapolis, Minnesota, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• University of Mississippi Medical Center
  Oxford, Mississippi, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Rebecca Arend, M.D. — University of Alabama at Birmingham
• Study coordinator: Rebecca Arend, M.D.
• Email: rarend@uabmc.edu
• Phone: 205-934-4986

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.