Recruiting
Phase 2

Carboplatin & Mirvetuximab Soravtansine

Sponsor:

University of Alabama at Birmingham

Code:

NCT04606914

Conditions

Ovarian Cancer

Fallopian Tube

Primary Peritoneal Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mirvetuximab soravtansine (MIRV; IMGN853)

Study Details

Brief summary:

The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in >75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT and after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of mirvetuximab + carboplatin for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate and the patient will be declared a screen failure. Patients with BRCA mutations are not excluded from this trial and are allowed to receive standard of care maintenance therapy including bevacizumab and/or PARP inhibitors.

Conditions

Ovarian Cancer

Fallopian Tube

Primary Peritoneal Cancer

Study ID

NCT04606914

Start date

May 27, 2021

Status verified date

Jul, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: alpha receptor positive neoadjuvant chemotherapy regimen

  • 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)

no intervention: Arm B: alpha receptor negative

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.

Interventions

mirvetuximab soravtansine (MIRV; IMGN853)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rebecca Arend, M.D.

205-934-4986rarend@uabmc.edu

Locations

University of Alabama at Birmingham Womens & Infants Center

Recruiting

Birmingham, Alabama, United States, 35233

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Jocelyn Chapman, MD

415-353-9600jocelyn.chapman@ucsf.edu

University of Minnesota - Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Britt Erickson, MD

612-676-4200bkeric@umn.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Andrea Hendrickson, MD

507-284-2511wahnerhendrickson.andrea@mayo.edu

University of Mississippi Medical Center

Recruiting

Oxford, Mississippi, United States, 36607

Contacts

Rodney Rocconi, MD

251-435-2273rocconi@umc.edu

Ohio State University

Recruiting

Columbus, Ohio, United States, 43026

Contacts

David O'Malley, MD

614-688-9220davidomalley@osumc.edu

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Debra Richardson, MD

405-271-8707debra-richardson@ouhsc.edu

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Thomas Krivack, MD

412-578-1116thomas.krivak@ahn.org

University of Virginia

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Marilyn Huang, MD

434-924-5100msh8f@uvhealth.org

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • First line treatment
  • Advanced epithelial ovarian cancer
  • mirvetuximab soravtansine
  • IMGN853

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-14.