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

Overview

About this study

The purpose of this study is to document the feasibility of carboplatin mirvetuximab in patients with advanced-stage epithelial ovarian cancer (EOC).  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 FR? positivity

- Patients must have a performance status of 0 or 1.

- Patient's tumor must be positive for FR? 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/?L)

- Platelet count ≥ 100 x 109/L (100,000/?L) 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 FR?-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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/12/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrea Wahner Hendrickson, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available