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

Multicenter, Open-label, Phase 2 Study of Carboplatin Plus Mirvetuximab Soravtansine Followed by Mirvetuximab Soravtansine Continuation in FRα Positive, Recurrent Platinum-sensitive, High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Following 1 Prior Line of Platinum-based Chemotherapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fallopian Tube Cancer; Primary Peritoneal Cancer; High Grade Ovarian Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: Mirvetuximab soravtansine

Detailed Description

This Phase 2 study is designed to evaluate the efficacy and safety of MIRV in combination with carboplatin followed by MIRV continuation in FRα-positive participants with recurrent platinum-sensitive ovarian cancer (PSOC) following 1 prior line of platinum-based chemotherapy. Upon completion of carboplatin plus MIRV combination chemotherapy (6 cycles), participants without progressive disease will continue on single-agent MIRV. Participants must have confirmation of FRα positivity by the Ventana folate receptor 1 (FOLR1) Assay.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Duplicate_CHU de Liege /ID# 268918
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1200
      • Cliniques Universitaires UCL Saint-Luc /ID# 268916
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 268914
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer - Vancouver /ID# 268901
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268902
    • Montreal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 268899
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre - Glen Site /ID# 269084
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Centre Hospitalier Universite De Sherbrooke - Hôtel-Dieu Hospital /ID# 268900
• Georgia
  • Tbilisi, Georgia, 0102
    • American Hospital Tbilisi /ID# 268947
  • Tbilisi, Georgia, 0103
    • High Technology Hospital MedCenter /ID# 268946
  • Tbilisi, Georgia, 0112
    • Israeli-Georgian Medical Research Clinic Helsicore /ID# 268950
  • Tbilisi, Georgia, 0159
    • Caraps Medline /ID# 268948
  • Tbilisi, Georgia, 0168
    • Duplicate_Consilium Medulla Multiprofile Clinic /ID# 268951
• Spain
  • Badajoz, Spain, 06010
    • Complejos Hospitalario Universitario de Badajoz /ID# 268937
  • Barcelona, Spain, 08028
    • Usp Instituto Universitario Dexeus /ID# 268931
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall de Hebron /ID# 268926
  • Lleida, Spain, 25198
    • Hospital Universitario Arnau de Vilanova de Lleida /ID# 268939
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra - Madrid /ID# 268935
  • Madrid, Spain, 28040
    • Hospital Universitario Fundación Jiménez Díaz /ID# 268938
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 268936
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro /ID# 268932
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia /ID# 268933
  • A Coruna
    • A Coruña, A Coruna, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña /ID# 268930
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Institut Català d'Oncologia (ICO) - Badalona /ID# 268929
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia /ID# 269657
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra - Pamplona /ID# 268940
• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • The Christie /ID# 268944
  • England
    • London, England, United Kingdom, W12 0HS
      • Hammersmith Hospital /ID# 268945
  • Greater London
    • London, Greater London, United Kingdom, SE1 9RT
      • Guy's Hospital /ID# 269083
    • London, Greater London, United Kingdom, SW3 6JJ
      • The Royal Marsden - Chelsea /ID# 268943
    • Northwood, Greater London, United Kingdom, HA6 2RN
      • Mount Vernon Hospital /ID# 268942
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
      • Nottinghamshire Healthcare NHS Foundation Trust /ID# 269087
  • Somerset
    • Taunton, Somerset, United Kingdom, TA1 5DA
      • Musgrove Park Hospital /ID# 269088
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden - Sutton /ID# 268941
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • University of Arizona Cancer Center /ID# 268906
  • California
    • Fresno, California, United States, 93710
      • Women'S Cancer Research Network - Cogi /ID# 268912
    • Fullerton, California, United States, 92835-3826
      • Providence - St. Jude Medical /ID# 268911
    • La Jolla, California, United States, 92037
      • Moores Cancer Center /ID# 268888
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles Medical Center /ID# 268883
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center /ID# 268964
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian /ID# 268907
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center /ID# 269085
    • San Diego, California, United States, 92103
      • Scripps Md Anderson - Prebys Cancer Center /ID# 268966
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center - Van Ness Campus /ID# 268886
  • Connecticut
    • New Haven, Connecticut, United States, 06519-1110
      • Smilow Cancer Hospital at Yale New Haven /ID# 268889
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando /ID# 268920
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital /ID# 268882
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center /ID# 269089
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University /ID# 268913
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 268957
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Women'S Cancer Care /ID# 268898
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 268879
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute /ID# 268881
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute - Detroit /ID# 268890
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Washington University School of Medicine - St. Louis /ID# 268897
  • Nevada
    • Reno, Nevada, United States, 89511
      • The Center Of Hope /ID# 268884
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Md Anderson Cancer Center At Cooper /ID# 268885
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center /ID# 268903
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Comprehensive Cancer Center /ID# 268961
    • Rio Rancho, New Mexico, United States, 87124
      • Presbyterian Rust Medical Center /ID# 278582
  • New York
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center /ID# 268909
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center /ID# 268887
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Medical Center /ID# 268963
    • Raleigh, North Carolina, United States, 27607
      • Duke Cancer Center Macon Pond /ID# 268910
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Health - Stephenson Cancer Center /ID# 268878
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital /ID# 268895
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Hollings Cancer Center /ID# 268892
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas - Southwestern Medical Center /ID# 268891
  • Washington
    • Kennewick, Washington, United States, 99336
      • Duplicate_Kadlec Clinic Heme-Onc /ID# 268580

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Drug: Carboplatin; Carboplatin is considered to be the treatment agent of choice in relapsed PSOC.; Drug: 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.; Other Names: MIRV; IGN853

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR following carboplatin plus MIRV combination as measured by the investigator and assessed according to RECIST v1.1, defined as the proportion of confirmed responders (CR or PR) among participants with FRα expression of ≥ 50% o ORR following carboplatin plus MIRV combination will also be measured, as a sensitivity analysis, by a blinded independent central review (BICR) in the same participant population	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR, defined as the proportion of confirmed responders (CR or PR) following carboplatin plus MIRV combination, as measured by the investigator and assessed according to RECIST v1.1, among patients with FRα expression of ≥ 25% of tumor cells with PS2+ staining intensity who have measurable disease per RECIST v1.1 at inclusion. o ORR will also be measured by a BICR, as a sensitivity analysis, in the same patient population.	Up to 3 years
Duration of Response (DOR)	DOR, defined as the time from first response to radiological progressive disease (PD) or death, whichever occurs first, following carboplatin plus MIRV followed by MIRV continuation by the investigator and assessed according to RECIST v1.1 among efficacy evaluable participants: with FRα expression of ≥ 50% of tumor cells with PS2+ staining and; with FRα expression of ≥ 25% of tumor cells with PS2+ staining; DOR in the above populations will also be measured by BICR	Up to 3 years
Progression Free Survival (PFS)	PFS as measured by the investigator and by BICR in participants with; FRα expression of ≥ 50% of tumor cells with PS2+ staining and; FRα expression of ≥ 25% of tumor cells with PS2+ staining	Up to 3 years
Overall Survival (OS)	OS in participants with; FRα expression of ≥ 50% of tumor cells with PS2+ staining and; FRα of ≥ 25% of tumor cells with PS2+ staining	Up to 3 years
Cancer Antigen (CA)-125 Response	CA-125 response as measured by the investigator, per Gynecologic Cancer Intergroup (GCIG), in the efficacy evaluable participants with; FRα expression of ≥ 50% of tumor cells with PS2+ staining and; FRα expression of ≥ 25% of tumor cells with PS2+ staining	Up to 3 years
Number of Participants With treatment Emergent Adverse Events (TEAEs)		Up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate biomarker levels with response to treatment	Correlate soluble FRα levels and other blood-based biomarkers with response to carboplatin plus MIRV treatment; Correlate tumor-based biomarkers and gene mutations with response to carboplatin plus MIRV combination	Up to 3 years
Correlate response in patients with prior PARPi use	• Correlate response to carboplatin plus MIRV in patients following PARP inhibitor use	Up to 3 years
Incidence of seroconversion	Identify incidence of seroconversion of anti-drug antibodies (ADA) to MIRV when given in combination with carboplatin and; Identify association with carboplatin plus MIRV safety and efficacy	Up to 3 years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: cancer; antibody-drug conjugate; platinum sensitive; ovarian neoplasm; folate-receptor alpha expression; high-grade ovarian
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Fallopian Tube Diseases; Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Organic Chemicals; Coordination Complexes; Carboplatin; mirvetuximab soravtansine
• Other Study ID Numbers: IMGN853-0420; 2022-501220-14-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No