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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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment70 people
  • Recruiting US sites9
  • SponsorUniversity of Alabama at Birmingham
  • RegistryNCT04606914

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

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: a one-minute explainerNCT046069141 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexFemale
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

mirvetuximab soravtansine. An immunoconjugate consisting of the humanized monoclonal antibody M9346A against folate receptor 1 (FOLR1) conjugated, via the disulfide-containing cleavable linker sulfo-SPDB, to the cytotoxic maytansinoid DM4, with potential antineoplastic activity. The anti-FOLR1 monoclonal antibody moiety of mirvetuximab soravtansine targets and binds to the cell surface antigen FOLR1. After antibody-antigen interaction and internalization, the immunoconjugate releases DM4, which binds to tubulin and disrupts microtubule assembly/disassembly dynamics, thereby inhibiting cell division and cell growth of FOLR1-expressing tumor cells. FOLR1, a member of the folate receptor family is overexpressed on a variety of epithelial-derived cancer cells. The sulfo-SPDB linker prevents cleavage in the bloodstream and may improve this agent's efficacy in multidrug resistant tumor cells. NCI Drug Dictionary

Treatments listed in the registry

  • mirvetuximab soravtansine (MIRV; IMGN853) (Drug): Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC) that consists of a high affinity humanized monoclonal antibody against folate receptor α (FRα, the protein product of the folate receptor 1 [FOLR1] gene) that is conjugated to a cytotoxic maytansinoid by the hindered disulfide succinimidyl 4-(pyridin-2-yl)disulfanyl)-2-sulfo-butyrate linker (sulfo-SPDB) linker. FRα is a glycosyl-phosphatidylinositol (GPI)-linked protein, which shows limited normal tissue expression and high expression on the surface of solid tumors, particularly epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (referenced herein collectively as EOC), endometrial cancer, non-small cell lung cancer (NSCLC), and renal cell cancer.

The study

Treatment groups

Non Randomized · Single Group · masking: None

Arm A: alpha receptor positive_neoadjuvant chemotherapy regimen (Experimental)

* IV Carboplatin AUC 5 (Q21 days) 7 cycles (first cycle is Carbo alone, dosing for C1D1 will be provider's choice) * IV Mirvetuximab 6 mg/kg (adjusted ideal body weight) day 1 (Q21 days) 6 cycles (starting with cycle #2)

Arm B: alpha receptor negative (No Intervention)

If a patient is found to be negative for FRα expression, they will be ineligible to receive the study treatment under the main study (Arm A). FRα negative patients will be enrolled under the biomarker-only arm (Arm B), and their treating physician can select the treatment they deem appropriate.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • biopsy: Part of the study plan
  • CT scans: Part of the study plan
  • MRI: Part of the study plan
  • surgery: Part of the study plan

Goals

What the study measures

Main goals

  • progression free survival (PFS) (Baseline through 2 years)
  • Objective response rate (ORR) (Baseline through 2 years)
  • Radiographic tumor assessment per RECIST v1.1 criteria (Baseline through 2 years)

Other goals

  • Serum Cancer Antigen 125 (CA-125) assessments
  • Safety profile of treatment with carboplatin-mirvetuximab soravtansine according to CTCAE v4.03

Planned enrollment: 70 (estimated).

Where

Recruiting US sites

  • University of Alabama at Birmingham Womens & Infants Center, Birmingham, Alabama
  • University of California San Francisco, San Francisco, California
  • University of Minnesota - Masonic Cancer Center, Minneapolis, Minnesota
  • Mayo Clinic, Rochester, Minnesota
  • University of Mississippi Medical Center, Oxford, Mississippi
  • Ohio State University, Columbus, Ohio
  • University of Oklahoma, Oklahoma City, Oklahoma
  • Allegheny Health Network, Pittsburgh, Pennsylvania
  • University of Virginia, Richmond, Virginia

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 13, 2026. Public record; not medical advice.

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