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

NCT05456685 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IMGN853-04202022-501220-14-00
• Study Type: interventional
• Target: 125
• Locations: 6 countries
• Sites: 69

Brief 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.

Conditions

High Grade Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Keywords

platinum sensitive; folate-receptor alpha expression; antibody-drug conjugate; cancer; ovarian neoplasm; high-grade ovarian

Outcome Measures

Primary Outcomes (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% 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 Outcomes (6)

• Overall Response Rate (ORR)

  Up to 3 years

• Duration of Response (DOR)

  Up to 3 years

• Progression Free Survival (PFS)

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

• Cancer Antigen (CA)-125 Response

  Up to 3 years

Study Arms (1)

MIRV + Carboplatin

EXPERIMENTAL

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: Mirvetuximab soravtansine; Drug: Carboplatin

Interventions

Mirvetuximab soravtansine DRUG

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.

Also known as: MIRV, IGN853

MIRV + Carboplatin

Carboplatin DRUG

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

MIRV + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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)
• 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)
• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (69)

University of Arizona Cancer Center /ID# 268906

Tucson, Arizona, 85704, United States

Location

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

Fresno, California, 93710, United States

Location

Providence - St. Jude Medical /ID# 268911

Fullerton, California, 92835-3826, United States

Location

Moores Cancer Center /ID# 268888

La Jolla, California, 92037, United States

Location

USC Norris Comprehensive Cancer Center /ID# 268964

Los Angeles, California, 90033, United States

Location

University of California Los Angeles Medical Center /ID# 268883

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian /ID# 268907

Newport Beach, California, 92663, United States

Location

UC Davis Comprehensive Cancer Center /ID# 269085

Sacramento, California, 95817, United States

Location

Scripps Md Anderson - Prebys Cancer Center /ID# 268966

San Diego, California, 92103, United States

Location

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

San Francisco, California, 94109, United States

Location

Smilow Cancer Hospital at Yale New Haven /ID# 268889

New Haven, Connecticut, 06519-1110, United States

Location

AdventHealth Orlando /ID# 268920

Orlando, Florida, 32803, United States

Location

Sarasota Memorial Hospital /ID# 268882

Sarasota, Florida, 34239, United States

Location

Moffitt Cancer Center /ID# 269089

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute of Emory University /ID# 268913

Atlanta, Georgia, 30322, United States

Location

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

Chicago, Illinois, 60610, United States

Location

Women'S Cancer Care /ID# 268898

Covington, Louisiana, 70433, United States

Location

Massachusetts General Hospital /ID# 268879

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute /ID# 268881

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute - Detroit /ID# 268890

Detroit, Michigan, 48201, United States

Location

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

St Louis, Missouri, 63130, United States

Location

The Center Of Hope /ID# 268884

Reno, Nevada, 89511, United States

Location

Md Anderson Cancer Center At Cooper /ID# 268885

Camden, New Jersey, 08103, United States

Location

Holy Name Medical Center /ID# 268903

Teaneck, New Jersey, 07666, United States

Location

University of New Mexico Comprehensive Cancer Center /ID# 268961

Albuquerque, New Mexico, 87102, United States

Location

Presbyterian Rust Medical Center /ID# 278582

Rio Rancho, New Mexico, 87124, United States

Location

Long Island Jewish Medical Center /ID# 268909

New Hyde Park, New York, 11040, United States

Location

Columbia University Irving Medical Center /ID# 268887

New York, New York, 10032, United States

Location

University of North Carolina Medical Center /ID# 268963

Chapel Hill, North Carolina, 27514, United States

Location

Duke Cancer Center Macon Pond /ID# 268910

Raleigh, North Carolina, 27607, United States

Location

OU Health - Stephenson Cancer Center /ID# 268878

Oklahoma City, Oklahoma, 73104, United States

Location

Women & Infants Hospital /ID# 268895

Providence, Rhode Island, 02905, United States

Location

MUSC Hollings Cancer Center /ID# 268892

Charleston, South Carolina, 29425, United States

Location

University of Texas - Southwestern Medical Center /ID# 268891

Dallas, Texas, 75235, United States

Location

Duplicate_Kadlec Clinic Heme-Onc /ID# 268580

Kennewick, Washington, 99336, United States

Location

Cliniques Universitaires UCL Saint-Luc /ID# 268916

Brussels, Brussels Capital, 1200, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 268914

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Duplicate_CHU de Liege /ID# 268918

Liège, 4000, Belgium

Location

BC Cancer - Vancouver /ID# 268901

Vancouver, British Columbia, V5Z 4E6, Canada

Location

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

Montreal, Quebec, H1T 2M4, Canada

Location

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

Montreal, Quebec, H2X 3E4, Canada

Location

McGill University Health Centre - Glen Site /ID# 269084

Montreal, Quebec, H4A 3J1, Canada

Location

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

Sherbrooke, Quebec, J1G 2E8, Canada

Location

American Hospital Tbilisi /ID# 268947

Tbilisi, 0102, Georgia

Location

High Technology Hospital MedCenter /ID# 268946

Tbilisi, 0103, Georgia

Location

Israeli-Georgian Medical Research Clinic Helsicore /ID# 268950

Tbilisi, 0112, Georgia

Location

Caraps Medline /ID# 268948

Tbilisi, 0159, Georgia

Location

Duplicate_Consilium Medulla Multiprofile Clinic /ID# 268951

Tbilisi, 0168, Georgia

Location

Complejo Hospitalario Universitario A Coruña /ID# 268930

A Coruña, A Coruna, 15006, Spain

Location

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

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Reina Sofia /ID# 269657

Córdoba, Cordoba, 14004, Spain

Location

Clinica Universidad de Navarra - Pamplona /ID# 268940

Pamplona, Navarre, 31008, Spain

Location

Complejos Hospitalario Universitario de Badajoz /ID# 268937

Badajoz, 06010, Spain

Location

Usp Instituto Universitario Dexeus /ID# 268931

Barcelona, 08028, Spain

Location

Hospital Universitario Vall de Hebron /ID# 268926

Barcelona, 08035, Spain

Location

Hospital Universitario Arnau de Vilanova de Lleida /ID# 268939

Lleida, 25198, Spain

Location

Clinica Universidad de Navarra - Madrid /ID# 268935

Madrid, 28027, Spain

Location

Hospital Universitario Fundación Jiménez Díaz /ID# 268938

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre /ID# 268936

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro /ID# 268932

Madrid, 28050, Spain

Location

Hospital Clínico Universitario de Valencia /ID# 268933

Valencia, 46010, Spain

Location

Hammersmith Hospital /ID# 268945

London, England, W12 0HS, United Kingdom

Location

Guy's Hospital /ID# 269083

London, Greater London, SE1 9RT, United Kingdom

Location

The Royal Marsden - Chelsea /ID# 268943

London, Greater London, SW3 6JJ, United Kingdom

Location

Mount Vernon Hospital /ID# 268942

Northwood, Greater London, HA6 2RN, United Kingdom

Location

Nottinghamshire Healthcare NHS Foundation Trust /ID# 269087

Nottingham, Nottinghamshire, NG3 6AA, United Kingdom

Location

Musgrove Park Hospital /ID# 269088

Taunton, Somerset, TA1 5DA, United Kingdom

Location

The Royal Marsden - Sutton /ID# 268941

Sutton, Surrey, SM2 5PT, United Kingdom

Location

The Christie /ID# 268944

Manchester, M20 4BX, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Neoplasms; Ovarian Neoplasms

Interventions

mirvetuximab soravtansine; Carboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 13, 2022
• Study Start: September 28, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (13); CA (5); BE (3); GB (8); US (35); GE (5)