A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

Completed · Phase 3

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

In brief

This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in participants with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All participants will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.

Key facts

Study ID

NCT04296890

Run by

ImmunoGen, Inc.

People needed

106

Starts

2020-07-23

Expected to finish

2022-11-16

Last updated by the study team

2024-08-07

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 serous epithelial ovarian cancer (EOC), 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 (complete response/remission [CR] or partial response/remission [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 (see exclusion criteria)
• Participants must have progressed radiographically on or after their most recent line of anticancer 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 Folate Receptor α (FRα) positivity
• Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay
• Participants must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator)
• Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab, and for whom single-agent therapy is appropriate as the next line of treatment:
• Adjuvant ± neoadjuvant considered 1 line of therapy
• Maintenance therapy (e.g., bevacizumab, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors) will be considered part of the preceding line of therapy (i.e., not counted independently)
• Therapy changed due to toxicity in the absence of progression will be considered part of the same line (i.e., not counted independently)
• Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
• Participants must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
• Participants must have completed prior therapy within the specified times below:
• Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of MIRV
• Focal radiation completed at least 2 weeks prior to first dose of MIRV
• Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia)
• Participants must have completed any major surgery at least 4 weeks prior to first dose of MIRV 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/L (1,500/μL) without G-CSF in the prior 10 days or long-acting 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

You may not qualify if…

• Male participants
• Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/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 percent of the bone marrow
• Participants with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
• 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 prior to the first dose of MIRV
• Note: Testing at screening is not required for the above infections unless clinically indicated
• Participants with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
• Participants 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
• Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
• Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)
• Participants with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis
• Participants requiring use of folate-containing supplements (eg, folate deficiency)
• Participants with prior hypersensitivity to monoclonal antibodies (mAb)
• Women who are pregnant or breastfeeding

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• California Cancer Associates (cCARE) — Fresno, California, United States
• Stanford School of Medicine — Palo Alto, California, United States
• California Pacific Medical Center Research Institute — San Francisco, California, United States
• Rocky Mountain Cancer Centers — Littleton, Colorado, United States
• Sarasota Memorial Health Care System — Sarasota, Florida, United States
• Florida Cancer Specialists Panhandle — Tallahassee, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Florida Cancer Specialists Research — West Palm Beach, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Hinsdale Hospital — Hinsdale, Illinois, United States
• St. Vincent Gynecologic Oncology — Indianapolis, Indiana, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Women's Cancer Center — Covington, Louisiana, United States
• Maryland Oncology Hematology, P.A. — Rockville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Midwest Oncology Associates/Sarah Cannon — Kansas City, Missouri, United States
• Center of Hope at Renown Medical Center — Reno, Nevada, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• Mount Sinai Health System — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Sarah Cannon Research Institute / Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• Arizona Oncology Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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