Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer
NCT ID: NCT05456685
Last Updated: 2025-10-28
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
125 participants
INTERVENTIONAL
2022-09-28
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MIRV + Carboplatin
On Day 1 of every 3-week cycle (Q3W) for 6 cycles, MIRV will be given at the dosage of 6 mg/kg of AIBW along with carboplatin given at area under the AUC5 administered through intravenous (IV) infusion (maximum dosing per National Comprehensive Cancer Network \[NCCN\] guidelines \[NCCN 2021\]). Upon completion of carboplatin plus MIRV treatment, single-agent MIRV will be continued at the tolerated dose on Day 1 Q3W in participants with investigator determined stable disease (SD), complete response (CR) or partial response (PR).
Mirvetuximab soravtansine
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called FRα. It is being developed for the treatment of participants with recurrent platinum-sensitive, high grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with FRα expression. FRα positivity will be defined by the Ventana FOLR1 Assay.
Carboplatin
Carboplatin is considered to be the treatment agent of choice in relapsed PSOC.
Interventions
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Mirvetuximab soravtansine
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called FRα. It is being developed for the treatment of participants with recurrent platinum-sensitive, high grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with FRα expression. FRα positivity will be defined by the Ventana FOLR1 Assay.
Carboplatin
Carboplatin is considered to be the treatment agent of choice in relapsed PSOC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
3. Must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
4. Must have relapsed after 1 prior line of platinum-based chemotherapy.
5. Must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of platinum-based chemotherapy. 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.
6. If available locally and is the standard of care, breast cancer susceptibility gene (BRCA) testing on the tumor or prior germline testing is required for eligibility, and will need to be done prior to study entry. Somatic and germline BRCA-positive participants must have received prior treatment with a poly adenosine phosphate-ribose polymerase inhibitor (PARPi) unless documented as clinically contraindicated.
7. Must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
8. Must 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; FRα-expressing tumors will be defined and classified by the Ventana FOLR1 Assay into low, medium, and high expressions defined as 25%-49%, 50%-74%, and ≥ 75% of tumor cells with PS2+ staining intensity, respectively. Must have confirmation of FRα positivity of ≥ 25% of tumor staining at ≥ 2+ intensity for entry into the study.
9. Must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia) and have discontinued any maintenance therapy at least 4 weeks before the first dose of carboplatin plus MIRV.
10. Must have completed any major surgery at least 4 weeks before the first dose of carboplatin plus MIRV and have recovered or stabilized from the side effects of prior surgery before the first dose of carboplatin plus MIRV.
11. Must have adequate hematologic, liver, and kidney functions defined as:
1. Absolute neutrophil count ≥ 1.5 × 10\^9/ liter(L) (1500/ microliter \[μL\]) without granulocyte colony-stimulating factor or long-acting white blood cell growth factors in the 10 days prior to the Cycle 1 Day 1 (C1D1) dose
2. Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the 10 days prior to the C1D1 dose
3. Hemoglobin ≥ 9.0 grams/deciliter (g/dL) without packed red blood cell transfusion in the 14 days prior to the C1D1 dose
4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
5. Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN
6. Serum bilirubin ≤ 1.5 × ULN (participants with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 × ULN)
7. Serum albumin ≥ 2 g/dL
12. Must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
13. Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method(s) while on study medication and for at least 3 months after the last dose of MIRV and 6 months after the last dose of carboplatin.
14. FCBP must have a negative pregnancy test within the 4 days prior to the C1D1 dose.
Exclusion Criteria
2. More than one line of prior chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
1. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.
2. Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the preceding line of therapy (ie, not counted independently).
3. Participants with prior wide-field radiotherapy affecting at least 20% of the bone marrow
4. Participants with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
5. 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, or monocular vision
6. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
1. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)or C infection (whether or not on active antiviral therapy)
2. HIV infection if inclusion clarifying eligibility for HIV positive participants is not met
3. Active cytomegalovirus infection
4. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of carboplatin plus MIRV Note: Testing at screening is not required for the above infections unless clinically indicated.
7. Participants with a history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
8. Participants with clinically significant cardiac disease including, but not limited to, any of the following:
1. Myocardial infarction ≤ 6 months prior to first dose
2. Unstable angina pectoris
3. Uncontrolled congestive heart failure (New York Heart Association \> class II)
4. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
5. Uncontrolled cardiac arrhythmias
9. Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
10. Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C)
11. Participants with a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic agent used in the treatment of their malignancy that has resolved per investigator or resolution of the radiologic findings)
12. Participants requiring use of folate-containing supplements (eg, folate deficiency)
13. Participants with prior hypersensitivity to monoclonal antibodies (mAb)
14. Females who are pregnant or breastfeeding
15. Participants who received prior treatment with MIRV or other FRαtargeting agents
16. Participants with untreated or symptomatic central nervous system metastases
17. Participants with a history of other malignancy within 3 years before enrollment Note: Participants 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.
18. Prior known hypersensitivity reactions or known contraindications to study drugs or any of their excipients
18 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Arizona Cancer Center /ID# 268906
Tucson, Arizona, United States
Women'S Cancer Research Network - Cogi /ID# 268912
Fresno, California, United States
Providence - St. Jude Medical /ID# 268911
Fullerton, California, United States
Moores Cancer Center /ID# 268888
La Jolla, California, United States
USC Norris Comprehensive Cancer Center /ID# 268964
Los Angeles, California, United States
University of California Los Angeles Medical Center /ID# 268883
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian /ID# 268907
Newport Beach, California, United States
UC Davis Comprehensive Cancer Center /ID# 269085
Sacramento, California, United States
Scripps Md Anderson - Prebys Cancer Center /ID# 268966
San Diego, California, United States
California Pacific Medical Center - Van Ness Campus /ID# 268886
San Francisco, California, United States
Smilow Cancer Hospital at Yale New Haven /ID# 268889
New Haven, Connecticut, United States
AdventHealth Orlando /ID# 268920
Orlando, Florida, United States
Sarasota Memorial Hospital /ID# 268882
Sarasota, Florida, United States
Moffitt Cancer Center /ID# 269089
Tampa, Florida, United States
Winship Cancer Institute of Emory University /ID# 268913
Atlanta, Georgia, United States
Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 268957
Chicago, Illinois, United States
Women'S Cancer Care /ID# 268898
Covington, Louisiana, United States
Massachusetts General Hospital /ID# 268879
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 268881
Boston, Massachusetts, United States
Karmanos Cancer Institute - Detroit /ID# 268890
Detroit, Michigan, United States
Washington University School of Medicine - St. Louis /ID# 268897
St Louis, Missouri, United States
The Center Of Hope /ID# 268884
Reno, Nevada, United States
Md Anderson Cancer Center At Cooper /ID# 268885
Camden, New Jersey, United States
Holy Name Medical Center /ID# 268903
Teaneck, New Jersey, United States
University of New Mexico Comprehensive Cancer Center /ID# 268961
Albuquerque, New Mexico, United States
Presbyterian Rust Medical Center /ID# 278582
Rio Rancho, New Mexico, United States
Long Island Jewish Medical Center /ID# 268909
New Hyde Park, New York, United States
Columbia University Irving Medical Center /ID# 268887
New York, New York, United States
University of North Carolina Medical Center /ID# 268963
Chapel Hill, North Carolina, United States
Duke Cancer Center Macon Pond /ID# 268910
Raleigh, North Carolina, United States
OU Health - Stephenson Cancer Center /ID# 268878
Oklahoma City, Oklahoma, United States
Women & Infants Hospital /ID# 268895
Providence, Rhode Island, United States
MUSC Hollings Cancer Center /ID# 268892
Charleston, South Carolina, United States
University of Texas - Southwestern Medical Center /ID# 268891
Dallas, Texas, United States
Duplicate_Kadlec Clinic Heme-Onc /ID# 268580
Kennewick, Washington, United States
Cliniques Universitaires UCL Saint-Luc /ID# 268916
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Leuven /ID# 268914
Leuven, Vlaams-Brabant, Belgium
Duplicate_CHU de Liege /ID# 268918
Liège, , Belgium
BC Cancer - Vancouver /ID# 268901
Vancouver, British Columbia, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268902
Montreal, Quebec, Canada
Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 268899
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site /ID# 269084
Montreal, Quebec, Canada
Centre Hospitalier Universite De Sherbrooke - Hôtel-Dieu Hospital /ID# 268900
Sherbrooke, Quebec, Canada
American Hospital Tbilisi /ID# 268947
Tbilisi, , Georgia
High Technology Hospital MedCenter /ID# 268946
Tbilisi, , Georgia
Israeli-Georgian Medical Research Clinic Helsicore /ID# 268950
Tbilisi, , Georgia
Caraps Medline /ID# 268948
Tbilisi, , Georgia
Duplicate_Consilium Medulla Multiprofile Clinic /ID# 268951
Tbilisi, , Georgia
Complejo Hospitalario Universitario A Coruña /ID# 268930
A Coruña, A Coruna, Spain
Institut Català d'Oncologia (ICO) - Badalona /ID# 268929
Badalona, Barcelona, Spain
Hospital Universitario Reina Sofia /ID# 269657
Córdoba, Cordoba, Spain
Clinica Universidad de Navarra - Pamplona /ID# 268940
Pamplona, Navarre, Spain
Complejos Hospitalario Universitario de Badajoz /ID# 268937
Badajoz, , Spain
Usp Instituto Universitario Dexeus /ID# 268931
Barcelona, , Spain
Hospital Universitario Vall de Hebron /ID# 268926
Barcelona, , Spain
Hospital Universitario Arnau de Vilanova de Lleida /ID# 268939
Lleida, , Spain
Clinica Universidad de Navarra - Madrid /ID# 268935
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz /ID# 268938
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 268936
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 268932
Madrid, , Spain
Hospital Clínico Universitario de Valencia /ID# 268933
Valencia, , Spain
Hammersmith Hospital /ID# 268945
London, England, United Kingdom
Guy's Hospital /ID# 269083
London, Greater London, United Kingdom
The Royal Marsden - Chelsea /ID# 268943
London, Greater London, United Kingdom
Mount Vernon Hospital /ID# 268942
Northwood, Greater London, United Kingdom
Nottinghamshire Healthcare NHS Foundation Trust /ID# 269087
Nottingham, Nottinghamshire, United Kingdom
Musgrove Park Hospital /ID# 269088
Taunton, Somerset, United Kingdom
The Royal Marsden - Sutton /ID# 268941
Sutton, Surrey, United Kingdom
The Christie /ID# 268944
Manchester, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2022-501220-14-00
Identifier Type: OTHER
Identifier Source: secondary_id
IMGN853-0420
Identifier Type: -
Identifier Source: org_study_id
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