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New hope for ovarian cancer: targeted combo shows promise in recurrent cases

NCT ID NCT05456685

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a two-step treatment for a type of ovarian cancer that has come back after initial chemotherapy. First, patients receive a standard chemo drug (carboplatin) plus a targeted drug (mirvetuximab) that homes in on a protein called FRα found on cancer cells. Then, they continue with mirvetuximab alone. The goal is to see how many patients' tumors shrink or disappear. The trial is for adults whose cancer is sensitive to platinum drugs and whose tumors have high levels of FRα.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

125 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer fallopian tube neoplasm neoplasm ovarian cancer ovarian carcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fallopian tube cancer High grade ovarian cancer Primary peritoneal cancer

Contacts and locations

Locations

  • AdventHealth Orlando /ID# 268920

    Orlando, Florida, 32803, United States

  • American Hospital Tbilisi /ID# 268947

    Tbilisi, 0102, Georgia

  • BC Cancer - Vancouver /ID# 268901

    Vancouver, British Columbia, V5Z 4E6, Canada

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

    San Francisco, California, 94109, United States

  • Caraps Medline /ID# 268948

    Tbilisi, 0159, Georgia

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

    Montreal, Quebec, H2X 3E4, Canada

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

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Clinica Universidad de Navarra - Madrid /ID# 268935

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona /ID# 268940

    Pamplona, Navarre, 31008, Spain

  • Cliniques Universitaires UCL Saint-Luc /ID# 268916

    Brussels, Brussels Capital, 1200, Belgium

  • Columbia University Irving Medical Center /ID# 268887

    New York, New York, 10032, United States

  • Complejo Hospitalario Universitario A Coruña /ID# 268930

    A Coruña, A Coruna, 15006, Spain

  • Complejos Hospitalario Universitario de Badajoz /ID# 268937

    Badajoz, 06010, Spain

  • Dana-Farber Cancer Institute /ID# 268881

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Center Macon Pond /ID# 268910

    Raleigh, North Carolina, 27607, United States

  • Duplicate_CHU de Liege /ID# 268918

    Liège, 4000, Belgium

  • Duplicate_Consilium Medulla Multiprofile Clinic /ID# 268951

    Tbilisi, 0168, Georgia

  • Duplicate_Kadlec Clinic Heme-Onc /ID# 268580

    Kennewick, Washington, 99336, United States

  • Guy's Hospital /ID# 269083

    London, Greater London, SE1 9RT, United Kingdom

  • Hammersmith Hospital /ID# 268945

    London, England, W12 0HS, United Kingdom

  • High Technology Hospital MedCenter /ID# 268946

    Tbilisi, 0103, Georgia

  • Hoag Memorial Hospital Presbyterian /ID# 268907

    Newport Beach, California, 92663, United States

  • Holy Name Medical Center /ID# 268903

    Teaneck, New Jersey, 07666, United States

  • Hospital Clínico Universitario de Valencia /ID# 268933

    Valencia, 46010, Spain

  • Hospital Universitario 12 de Octubre /ID# 268936

    Madrid, 28041, Spain

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

    Lleida, 25198, Spain

  • Hospital Universitario Fundación Jiménez Díaz /ID# 268938

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro /ID# 268932

    Madrid, 28050, Spain

  • Hospital Universitario Reina Sofia /ID# 269657

    Córdoba, Cordoba, 14004, Spain

  • Hospital Universitario Vall de Hebron /ID# 268926

    Barcelona, 08035, Spain

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

    Badalona, Barcelona, 08916, Spain

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

    Tbilisi, 0112, Georgia

  • Karmanos Cancer Institute - Detroit /ID# 268890

    Detroit, Michigan, 48201, United States

  • Long Island Jewish Medical Center /ID# 268909

    New Hyde Park, New York, 11040, United States

  • MUSC Hollings Cancer Center /ID# 268892

    Charleston, South Carolina, 29425, United States

  • Massachusetts General Hospital /ID# 268879

    Boston, Massachusetts, 02114, United States

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

    Montreal, Quebec, H4A 3J1, Canada

  • Md Anderson Cancer Center At Cooper /ID# 268885

    Camden, New Jersey, 08103, United States

  • Moffitt Cancer Center /ID# 269089

    Tampa, Florida, 33612, United States

  • Moores Cancer Center /ID# 268888

    La Jolla, California, 92037, United States

  • Mount Vernon Hospital /ID# 268942

    Northwood, Greater London, HA6 2RN, United Kingdom

  • Musgrove Park Hospital /ID# 269088

    Taunton, Somerset, TA1 5DA, United Kingdom

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

    Chicago, Illinois, 60610, United States

  • Nottinghamshire Healthcare NHS Foundation Trust /ID# 269087

    Nottingham, Nottinghamshire, NG3 6AA, United Kingdom

  • OU Health - Stephenson Cancer Center /ID# 268878

    Oklahoma City, Oklahoma, 73104, United States

  • Presbyterian Rust Medical Center /ID# 278582

    Rio Rancho, New Mexico, 87124, United States

  • Providence - St. Jude Medical /ID# 268911

    Fullerton, California, 92835-3826, United States

  • Sarasota Memorial Hospital /ID# 268882

    Sarasota, Florida, 34239, United States

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

    San Diego, California, 92103, United States

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

    New Haven, Connecticut, 06519-1110, United States

  • The Center Of Hope /ID# 268884

    Reno, Nevada, 89511, United States

  • The Christie /ID# 268944

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden - Chelsea /ID# 268943

    London, Greater London, SW3 6JJ, United Kingdom

  • The Royal Marsden - Sutton /ID# 268941

    Sutton, Surrey, SM2 5PT, United Kingdom

  • UC Davis Comprehensive Cancer Center /ID# 269085

    Sacramento, California, 95817, United States

  • USC Norris Comprehensive Cancer Center /ID# 268964

    Los Angeles, California, 90033, United States

  • Universitair Ziekenhuis Leuven /ID# 268914

    Leuven, Vlaams-Brabant, 3000, Belgium

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

    Montreal, Quebec, H1T 2M4, Canada

  • University of Arizona Cancer Center /ID# 268906

    Tucson, Arizona, 85704, United States

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

    Los Angeles, California, 90095, United States

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

    Albuquerque, New Mexico, 87102, United States

  • University of North Carolina Medical Center /ID# 268963

    Chapel Hill, North Carolina, 27514, United States

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

    Dallas, Texas, 75235, United States

  • Usp Instituto Universitario Dexeus /ID# 268931

    Barcelona, 08028, Spain

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

    St Louis, Missouri, 63130, United States

  • Winship Cancer Institute of Emory University /ID# 268913

    Atlanta, Georgia, 30322, United States

  • Women & Infants Hospital /ID# 268895

    Providence, Rhode Island, 02905, United States

  • Women'S Cancer Care /ID# 268898

    Covington, Louisiana, 70433, United States

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

    Fresno, California, 93710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.