A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

Completed · Phase 3

Conditions studied: Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

In brief

This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

Key facts

Study ID

NCT04209855

Run by

AbbVie

People needed

453

Starts

2019-12-31

Expected to finish

2024-10-29

Last updated by the study team

2025-08-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female participants ≥ 18 years of age
• Participants must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
• Participants must have platinum-resistant disease:
• Participants who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between >3 months and ≤ 6 months after the date of the last dose of platinum
• Participants who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. Note: Participants who are platinum-refractory during front-line treatment are excluded
• Participants must have progressed radiographically on or after their most recent line of therapy
• Participants 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
• Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay
• Participants must have at least one lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (radiologically measured by the Investigator)
• Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:
• Adjuvant ± neoadjuvant considered one line of therapy
• Maintenance therapy (for example, bevacizumab, poly (ADP-ribose) polymerase [PARP] inhibitors) will be considered as part of the preceding line of therapy (that is, not counted independently)
• Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (that is, not counted independently)
• Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
• Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• Time from prior therapy:
• Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)
• Focal radiation completed at least 2 weeks prior to first dose of study drug
• Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities
• Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery
• Participants must have adequate hematologic, liver and kidney functions defined as:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/liter (L) (1,500/microliter [μL]) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 20 days
• Platelet count ≥ 100 x 10\^9/L (100,000/μL) without platelet transfusion in the prior 10 days
• Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN)

You may not qualify if…

• Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor
• Participants with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy
• Participants with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
• Participants with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
• Participants 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
• Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
• Active hepatitis B or C infection (whether or not on active antiviral therapy)
• Human immunodeficiency virus (HIV) infection
• Active cytomegalovirus infection
• Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before starting study drug Note: Testing at screening is not required for the above infections unless clinically indicated
• Participants with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
• Participants with clinically significant cardiac disease including, but not limited to, any one 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
• Participants assigned to PLD stratum only: Left ventricular ejection fraction (LVEF) below the institutional limit of normal as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan
• Participants with a history of hemorrhagic or ischemic stroke within six months prior to randomization
• Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)
• Participants with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis
• Participants with required use of folate-containing supplements (for example, folate deficiency)
• Participants with prior hypersensitivity to monoclonal antibodies
• Women who are pregnant or lactating
• Participants with prior treatment with MIRV or other FRα-targeting agents

Where it is running

• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Arizona Oncology Associates, PC - HAL - USOR — Phoenix, Arizona, United States
• Mayo Clinic — Phoenix, Arizona, United States
• USOR: Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit — Los Angeles, California, United States
• Hoag Cancer Center — Newport Beach, California, United States
• University of California San Francisco — San Francisco, California, United States
• Olive View - UCLA Medical Center — Sylmar, California, United States
• Kaiser Permanente Oncology Clinical Trials — Vallejo, California, United States
• USOR: Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Florida Cancer Specialist South Division — Fort Myers, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Women's Care Florida / Women's Cancer Associates — St. Petersburg, Florida, United States
• Florida Cancer Specialist North Division — St. Petersburg, Florida, United States
• Florida Cancer Specialists — Tallahassee, Florida, United States
• Florida Cancer Specialist East Division — West Palm Beach, Florida, United States
• Memorial University Medical Center — Savannah, Georgia, United States
• Hawaii Pacific Health - Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Dr. Sudarshan K. Sharma, Ltd. — Hinsdale, Illinois, United States
• University of Alabama at Birmingham (UAB) GYN Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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