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High Grade Ovarian CancerPhase 2NCT05456685

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

A Phase 2 study testing Mirvetuximab soravtansine and Carboplatin in people with High Grade Ovarian Cancer and Primary Peritoneal Cancer, run by AbbVie at 69 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mirvetuximab soravtansine and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
69 sitesin 6 countries
Study dates
28 Sep 2022to Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be ≥ 18 years of age.
  • Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
  • Must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Must have relapsed after 1 prior line of platinum-based chemotherapy.
  • 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.
  • 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.
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  • Must have at least 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
  • 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.
  • 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.
  • 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.
  • Must have adequate hematologic, liver, and kidney functions defined as:
  • 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
  • Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the 10 days prior to the C1D1 dose
  • Hemoglobin ≥ 9.0 grams/deciliter (g/dL) without packed red blood cell transfusion in the 14 days prior to the C1D1 dose
  • Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
  • Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN
  • Serum bilirubin ≤ 1.5 × ULN (participants with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 × ULN)
  • Serum albumin ≥ 2 g/dL
  • Must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
  • 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.
  • FCBP must have a negative pregnancy test within the 4 days prior to the C1D1 dose.

Who cannot join

  • Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above types, or low-grade/ borderline ovarian tumor
  • More than one line of prior chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:
  • 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.
  • Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the preceding line of therapy (ie, not counted independently).
  • Participants with prior wide-field radiotherapy affecting at least 20% of the bone marrow
  • Participants with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
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  • 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
  • Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV)or C infection (whether or not on active antiviral therapy)
  • HIV infection if inclusion clarifying eligibility for HIV positive participants is not met
  • Active cytomegalovirus infection
  • 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.
  • Participants with a 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 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, 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)
  • Participants requiring use of folate-containing supplements (eg, folate deficiency)
  • Participants with prior hypersensitivity to monoclonal antibodies (mAb)
  • Females who are pregnant or breastfeeding
  • Participants who received prior treatment with MIRV or other FRαtargeting agents
  • Participants with untreated or symptomatic central nervous system metastases
  • 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.
  • Prior known hypersensitivity reactions or known contraindications to study drugs or any of their excipients

Trial locations and contacts

69 sites in 6 countries.

69 sites in 6 countries

United States35 sites

  • University of New Mexico Comprehensive Cancer Center /ID# 268961

    Albuquerque, New Mexico, 87102

  • Winship Cancer Institute of Emory University /ID# 268913

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital /ID# 268879

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute /ID# 268881

    Boston, Massachusetts, 02215

  • Md Anderson Cancer Center At Cooper /ID# 268885

    Camden, New Jersey, 08103

  • University of North Carolina Medical Center /ID# 268963

    Chapel Hill, North Carolina, 27514

  • MUSC Hollings Cancer Center /ID# 268892

    Charleston, South Carolina, 29425

  • Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 268957

    Chicago, Illinois, 60610

  • Women'S Cancer Care /ID# 268898

    Covington, Louisiana, 70433

  • University of Texas - Southwestern Medical Center /ID# 268891

    Dallas, Texas, 75235

  • Karmanos Cancer Institute - Detroit /ID# 268890

    Detroit, Michigan, 48201

  • Women'S Cancer Research Network - Cogi /ID# 268912

    Fresno, California, 93710

  • Providence - St. Jude Medical /ID# 268911

    Fullerton, California, 92835-3826

  • Duplicate_Kadlec Clinic Heme-Onc /ID# 268580

    Kennewick, Washington, 99336

  • Moores Cancer Center /ID# 268888

    La Jolla, California, 92037

  • USC Norris Comprehensive Cancer Center /ID# 268964

    Los Angeles, California, 90033

  • University of California Los Angeles Medical Center /ID# 268883

    Los Angeles, California, 90095

  • Smilow Cancer Hospital at Yale New Haven /ID# 268889

    New Haven, Connecticut, 06519-1110

  • Long Island Jewish Medical Center /ID# 268909

    New Hyde Park, New York, 11040

  • Columbia University Irving Medical Center /ID# 268887

    New York, New York, 10032

  • Hoag Memorial Hospital Presbyterian /ID# 268907

    Newport Beach, California, 92663

  • OU Health - Stephenson Cancer Center /ID# 268878

    Oklahoma City, Oklahoma, 73104

  • AdventHealth Orlando /ID# 268920

    Orlando, Florida, 32803

  • Women & Infants Hospital /ID# 268895

    Providence, Rhode Island, 02905

  • Duke Cancer Center Macon Pond /ID# 268910

    Raleigh, North Carolina, 27607

  • The Center Of Hope /ID# 268884

    Reno, Nevada, 89511

  • Presbyterian Rust Medical Center /ID# 278582

    Rio Rancho, New Mexico, 87124

  • UC Davis Comprehensive Cancer Center /ID# 269085

    Sacramento, California, 95817

  • Scripps Md Anderson - Prebys Cancer Center /ID# 268966

    San Diego, California, 92103

  • California Pacific Medical Center - Van Ness Campus /ID# 268886

    San Francisco, California, 94109

  • Sarasota Memorial Hospital /ID# 268882

    Sarasota, Florida, 34239

  • Washington University School of Medicine - St. Louis /ID# 268897

    St Louis, Missouri, 63130

  • Moffitt Cancer Center /ID# 269089

    Tampa, Florida, 33612

  • Holy Name Medical Center /ID# 268903

    Teaneck, New Jersey, 07666

  • University of Arizona Cancer Center /ID# 268906

    Tucson, Arizona, 85704

Other trials in United States

Spain13 sites

  • Complejo Hospitalario Universitario A Coruña /ID# 268930

    A Coruña, A Coruna, 15006

  • Complejos Hospitalario Universitario de Badajoz /ID# 268937

    Badajoz, 06010

  • Institut Català d'Oncologia (ICO) - Badalona /ID# 268929

    Badalona, Barcelona, 08916

  • Usp Instituto Universitario Dexeus /ID# 268931

    Barcelona, 08028

  • Hospital Universitario Vall de Hebron /ID# 268926

    Barcelona, 08035

  • Hospital Universitario Reina Sofia /ID# 269657

    Córdoba, Cordoba, 14004

  • Hospital Universitario Arnau de Vilanova de Lleida /ID# 268939

    Lleida, 25198

  • Clinica Universidad de Navarra - Madrid /ID# 268935

    Madrid, 28027

  • Hospital Universitario Fundación Jiménez Díaz /ID# 268938

    Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 268936

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro /ID# 268932

    Madrid, 28050

  • Clinica Universidad de Navarra - Pamplona /ID# 268940

    Pamplona, Navarre, 31008

  • Hospital Clínico Universitario de Valencia /ID# 268933

    Valencia, 46010

Other trials in Spain

United Kingdom8 sites

  • Hammersmith Hospital /ID# 268945

    London, England, W12 0HS

  • Guy's Hospital /ID# 269083

    London, Greater London, SE1 9RT

  • The Royal Marsden - Chelsea /ID# 268943

    London, Greater London, SW3 6JJ

  • The Christie /ID# 268944

    Manchester, M20 4BX

  • Mount Vernon Hospital /ID# 268942

    Northwood, Greater London, HA6 2RN

  • Nottinghamshire Healthcare NHS Foundation Trust /ID# 269087

    Nottingham, Nottinghamshire, NG3 6AA

  • The Royal Marsden - Sutton /ID# 268941

    Sutton, Surrey, SM2 5PT

  • Musgrove Park Hospital /ID# 269088

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Canada5 sites

  • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 268902

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier De L'Universite De Montreal - Hopital Saint-Luc /ID# 268899

    Montreal, Quebec, H2X 3E4

  • McGill University Health Centre - Glen Site /ID# 269084

    Montreal, Quebec, H4A 3J1

  • Centre Hospitalier Universite De Sherbrooke - Hôtel-Dieu Hospital /ID# 268900

    Sherbrooke, Quebec, J1G 2E8

  • BC Cancer - Vancouver /ID# 268901

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Georgia5 sites

  • American Hospital Tbilisi /ID# 268947

    Tbilisi, 0102

  • High Technology Hospital MedCenter /ID# 268946

    Tbilisi, 0103

  • Israeli-Georgian Medical Research Clinic Helsicore /ID# 268950

    Tbilisi, 0112

  • Caraps Medline /ID# 268948

    Tbilisi, 0159

  • Duplicate_Consilium Medulla Multiprofile Clinic /ID# 268951

    Tbilisi, 0168

Other trials in Georgia

Belgium3 sites

  • Cliniques Universitaires UCL Saint-Luc /ID# 268916

    Brussels, Brussels Capital, 1200

  • Universitair Ziekenhuis Leuven /ID# 268914

    Leuven, Vlaams-Brabant, 3000

  • Duplicate_CHU de Liege /ID# 268918

    Liège, 4000

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
Mirvetuximab soravtansine, Carboplatin
Keywords
platinum sensitive, folate-receptor alpha expression, antibody-drug conjugate, cancer, ovarian neoplasm, high-grade ovarian
Medical subject headings
Fallopian Tube Neoplasms, Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirvetuximab soravtansineDrug

    Also called MIRV, IGN853

    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.

  • CarboplatinDrug

    Carboplatin is considered to be the treatment agent of choice in relapsed PSOC.

Study groups in NCT05456685
Study groupRoleWhat they receive
MIRV + CarboplatinExperimentalOn 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).
Receives: Drug: Mirvetuximab soravtansine; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%

    • 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

    Measured: Up to 3 years

Secondary outcomes (6)

  1. 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.

    • ORR will also be measured by a BICR, as a sensitivity analysis, in the same patient population.

    Measured: Up to 3 years

  2. 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

    Measured: Up to 3 years

  3. 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

    Measured: Up to 3 years

  4. 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

    Measured: Up to 3 years

  5. 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

    Measured: Up to 3 years

  6. Number of Participants With treatment Emergent Adverse Events (TEAEs)

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start28 Sep 2022
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05456685
Sponsor's protocol ID
IMGN853-0420
Other IDs
2022-501220-14-00
Status last verified
Oct 2025
First submitted
29 Jun 2022
Last updated
28 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirvetuximab soravtansine and Carboplatin in people with High Grade Ovarian Cancer and Primary Peritoneal Cancer, run by AbbVie at 69 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Spain, United Kingdom, Canada, Georgia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05456685.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.

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