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Carboplatin and Mirvetuximab Soravtansine for Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This study is looking at a new way to treat advanced ovarian, fallopian tube, or primary peritoneal cancer. It combines a standard chemotherapy, carboplatin, with a drug called mirvetuximab soravtansine. Mirvetuximab soravtansine is an antibody-drug conjugate (ADC), which means it's designed to specifically target cancer cells that have a certain protein called folate receptor alpha (FRα) on their surface. The study will include about 70 women whose cancer has this FRα protein. Researchers want to see how well this combination shrinks tumors and how long patients live without their cancer growing. To join, you must have newly diagnosed, advanced-stage high-grade serous epithelial ovarian cancer and be eligible for initial chemotherapy.

Study design
This is a single-arm Phase II study, meaning all 70 participants will receive the same treatment combination.
What's involved
You would receive one cycle of carboplatin, followed by three cycles of mirvetuximab soravtansine plus carboplatin every 21 days, before surgery. You would also need to provide a tumor tissue sample.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow your progress for up to two years to assess how long you live without your cancer growing and how well the treatment shrinks your tumor.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04606914

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Alabama at Birmingham
~70 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:mirvetuximab soravtansine (MIRV; IMGN853)

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
progression free survival (PFS)
Measured over Baseline through 2 years
+2 more outcomes measured

Conditions

Ovarian Cancer
Fallopian Tube
Primary Peritoneal Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal CancerFRα

Where it's being run

9 sites across 8 states
Minnesota2
Alabama1
California1
Mississippi1
Ohio1
Oklahoma1
Pennsylvania1
Virginia1

Study leadership

  • Rebecca Arend, M.D. · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Rebecca Arend, M.D.
[email protected]
205-934-4986
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • progression free survival (PFS)Baseline through 2 years

    To assess percentage of patients with advanced-stage ovarian, fallopian tube, and peritoneal cancers per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 and Gynecological Cancer Intergroup Cancer antigen 125 (GCIG CA-125) criteria.

  • Objective response rate (ORR)Baseline through 2 years

    To assess ORR per iRECIST 1.1 and GCIG CA-125 criteria

  • Radiographic tumor assessment per RECIST v1.1 criteriaBaseline through 2 years

    Radiographic tumor response by CT or MRI of chest, abdomen, and pelvis using RECIST v1.1