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Clinical Trials in the UK / NCT05456685
Active, not recruiting Phase 2

Mirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer

NCT05456685 · tracked via the Priya Life Science UK tracker
Sponsor
AbbVie
Phase
Phase 2
Started
2022-09-28
Last updated
2025-10-28

Condition(s) studied

High Grade Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer

Investigational drug(s) / intervention(s)

Mirvetuximab soravtansineCarboplatin

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.

Study summary

IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Must be ≥ 18 years of age. 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: 1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above types, or low-grade/ borderline ovarian tumor 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

Primary outcome measure(s)

Trial sites (69)

FacilityCityRegionStatus
University of Arizona Cancer Center /ID# 268906 Tucson Arizona
Women'S Cancer Research Network - Cogi /ID# 268912 Fresno California
Providence - St. Jude Medical /ID# 268911 Fullerton California
Moores Cancer Center /ID# 268888 La Jolla California
USC Norris Comprehensive Cancer Center /ID# 268964 Los Angeles California
University of California Los Angeles Medical Center /ID# 268883 Los Angeles California
Hoag Memorial Hospital Presbyterian /ID# 268907 Newport Beach California
UC Davis Comprehensive Cancer Center /ID# 269085 Sacramento California
Scripps Md Anderson - Prebys Cancer Center /ID# 268966 San Diego California
California Pacific Medical Center - Van Ness Campus /ID# 268886 San Francisco California
Smilow Cancer Hospital at Yale New Haven /ID# 268889 New Haven Connecticut
AdventHealth Orlando /ID# 268920 Orlando Florida
Sarasota Memorial Hospital /ID# 268882 Sarasota Florida
Moffitt Cancer Center /ID# 269089 Tampa Florida
Winship Cancer Institute of Emory University /ID# 268913 Atlanta Georgia
Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 268957 Chicago Illinois
Women'S Cancer Care /ID# 268898 Covington Louisiana
Massachusetts General Hospital /ID# 268879 Boston Massachusetts
Dana-Farber Cancer Institute /ID# 268881 Boston Massachusetts
Karmanos Cancer Institute - Detroit /ID# 268890 Detroit Michigan
Washington University School of Medicine - St. Louis /ID# 268897 St Louis Missouri
The Center Of Hope /ID# 268884 Reno Nevada
Md Anderson Cancer Center At Cooper /ID# 268885 Camden New Jersey
Holy Name Medical Center /ID# 268903 Teaneck New Jersey
University of New Mexico Comprehensive Cancer Center /ID# 268961 Albuquerque New Mexico
Presbyterian Rust Medical Center /ID# 278582 Rio Rancho New Mexico
Long Island Jewish Medical Center /ID# 268909 New Hyde Park New York
Columbia University Irving Medical Center /ID# 268887 New York New York
University of North Carolina Medical Center /ID# 268963 Chapel Hill North Carolina
Duke Cancer Center Macon Pond /ID# 268910 Raleigh North Carolina
OU Health - Stephenson Cancer Center /ID# 268878 Oklahoma City Oklahoma
Women & Infants Hospital /ID# 268895 Providence Rhode Island
MUSC Hollings Cancer Center /ID# 268892 Charleston South Carolina
University of Texas - Southwestern Medical Center /ID# 268891 Dallas Texas
Duplicate_Kadlec Clinic Heme-Onc /ID# 268580 Kennewick Washington
Cliniques Universitaires UCL Saint-Luc /ID# 268916 Brussels Brussels Capital
Universitair Ziekenhuis Leuven /ID# 268914 Leuven Vlaams-Brabant
Duplicate_CHU de Liege /ID# 268918 Liège Belgium
BC Cancer - Vancouver /ID# 268901 Vancouver British Columbia
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268902 Montreal Quebec

+ 29 more sites — see the full list on the official registry below.

More AbbVie trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05456685 on ClinicalTrials.gov ↗ ← All trials in the UK