New drug shows promise for Hard-to-Treat ovarian cancer

NCT ID NCT05041257

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

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

Summary

This phase 2 trial tested a drug called mirvetuximab soravtansine in 79 people with recurrent platinum-sensitive ovarian, peritoneal, or fallopian tube cancers that have high levels of a protein called folate receptor-alpha. The drug is given by IV every three weeks. The main goal was to see how many participants' tumors shrank or disappeared. This study aims to offer a new treatment option for those whose cancer has returned after initial therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: mirvetuximab soravtansine (a drug that targets cancer cells with high folate receptor-alpha)
What this could lead to: If successful, this could provide a new treatment option for people with recurrent ovarian cancer that still responds to platinum therapy.
What could go wrong: This is a small, single-arm phase 2 study without a comparison group, so results may not confirm effectiveness. Side effects from the drug could also limit its use.

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

79 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 2024

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. Participants ≥ 18 years of age 2. Participants must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 3. Participants must have a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer 4. Participants must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of most recent platinum therapy 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 5. Participants must have progressed radiographically on or after their most recent line of anticancer therapy 6. Participants must have at least 1 lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (radiologically measured by the Investigator) 7. Participants must be willing to 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 8. Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 Assay 9. Prior anticancer therapy 1. Participants must have received at least 2 prior systemic lines of platinum therapy and be considered by the Investigator as appropriate for single-agent non-platinum therapy (documentation required - for example, high risk of hypersensitivity reaction; risk of further cumulative toxicity with additional platinum, including but not limited to myelosuppression, neuropathy, renal insufficiency or other) i. Note: Participants who have had a documented platinum allergy may have had only 1 prior line of platinum 2. Participants may have received up to but no more than 1 prior independent non-platinum cytotoxic therapy 3. Participants must have had testing for breast cancer susceptibility gene (BRCA) mutation (tumor or germline) and, if positive, must have received a prior poly (ADP-ribose) polymerase (PARP) inhibitor as either treatment or maintenance therapy 4. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy 5. Maintenance therapy (for example, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (that is, not counted independently) 6. Therapy changed due to toxicity in the absence of progression will be considered part of the same line (that is, not counted independently) 10. Participants must have completed prior therapy within the specified times below: 1. Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to first dose of MIRV 2. Focal radiation completed at least 2 weeks prior to first dose of MIRV 11. Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia) 12. Participants must have completed any major surgery at least 4 weeks prior to first dose of MIRV and have recovered or stabilized from the side effects of prior surgery prior to first dose of MIRV 13. Participants must have adequate hematologic, liver and kidney functions defined as: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/liter (L) (1500/microliter \[μL\]) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 20 days 2. Platelet count ≥ 100 x 10\^9/L (100,000/μL) without platelet transfusion in the prior 10 days 3. Hemoglobin ≥ 9.0 grams (g)/deciliter (dL) without packed red blood cell (PRBC) transfusion in the prior 21 days 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 6. Serum bilirubin ≤ 1.5 x ULN (participants with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN) 7. Serum albumin ≥ 2 g/dL 14. Participants must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements 15. Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for at least 3 months after the last dose 16. WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV Exclusion Criteria: 1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/ borderline ovarian tumor 2. Participants with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow 3. Participants with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) 4. 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, and/or monocular vision 5. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following: 1. Active hepatitis B or C infection (whether or not on active antiviral therapy) 2. Human immunodeficiency virus (HIV) infection 3. Active cytomegalovirus infection 4. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV Note: Testing at screening is not required for the above infections unless clinically indicated. 6. Participants with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome) 7. 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 8. Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment 9. Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C) 10. Participants with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonitis 11. Participants requiring use of folate-containing supplements (for example, folate deficiency) 12. Participants with prior hypersensitivity to monoclonal antibodies (mAb) 13. Women who are pregnant or breastfeeding 14. Participants who received prior treatment with MIRV or other FRα-targeting agents 15. Participants with untreated or symptomatic central nervous system (CNS) metastases 16. Participants with a history of other malignancy within 3 years prior to enrollment Note: Participants with tumors with a negligible risk for metastasis or death (for example, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible. 17. Prior known hypersensitivity reactions to study drugs and/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 serous adenocarcinoma peritoneum cancer primary peritoneal carcinoma

As listed by the trial registrant

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

Fallopian tube cancer Ovarian cancer Peritoneal cancer

Contacts and locations

Locations

Bon Secours Cork Hospital /ID# 269851

Cork, T12 DV56, Ireland
Centre Armoricain de Radiotherapie Imagerie & Oncologie (CARIO) /ID# 269847

Plérin, Cotes-d Armor, 22190, France
Centre Leon Berard /ID# 269848

Lyon, Rhone, 69373, France
City of Hope National Medical Center /ID# 269928

Duarte, California, 91010, United States
Cleveland Clinic Main Campus /ID# 269922

Cleveland, Ohio, 44195, United States
Duplicate_SCRI - Tennessee Oncology /ID# 269921

Nashville, Tennessee, 37203-1632, United States
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 269861

Rome, Roma, 00168, Italy
Holy Name Medical Center /ID# 269927

Teaneck, New Jersey, 07666, United States
Hospital Clínico Universitario de Valencia /ID# 269893

Valencia, 46010, Spain
Hospital MD Anderson Cancer Center Madrid /ID# 269888

Madrid, 28033, Spain
Hospital Universitario HM Sanchinarro /ID# 269891

Madrid, 28050, Spain
Hospital Universitario La Paz /ID# 269890

Madrid, 28046, Spain
Hospital Universitario Reina Sofia /ID# 269892

Córdoba, Cordoba, 14004, Spain
Hospital Universitario Vall d'Hebron /ID# 269889

Barcelona, 08035, Spain
Hospital Universitario Virgen del Rocio /ID# 269894

Seville, 41013, Spain
Hospital Universitario de Jaén /ID# 269895

Jaén, Jaen, 23007, Spain
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 269862

Bologna, 40138, Italy
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 269846

Saint-Herblain, Loire-Atlantique, 44805, France
Institut de cancérologie Strasbourg Europe (ICANS) /ID# 269849

Strasbourg, 67200, France
Istituto Europeo Di Oncologia /ID# 269860

Milan, Milano, 20141, Italy
Istituto Nazionale Dei Tumori /ID# 269864

Milan, Milano, 20133, Italy
Istituto Nazionale Tumori Irccs Fondazione G. Pascale /ID# 269863

Naples, Napoli, 80131, Italy
Monash Health - Monash Medical Centre /ID# 269735

Clayton, Victoria, 3168, Australia
Newcastle Private Hosptial /ID# 269734

Lambton Heights, New South Wales, 2305, Australia
Texas Oncology - South Austin /ID# 269924

Austin, Texas, 78745, United States
The Mark H Zangmeister Center /ID# 269929

Columbus, Ohio, 43219, United States
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 269738

Namur, 5000, Belgium
UZ Gent /ID# 269737

Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 269736

Leuven, Vlaams-Brabant, 3000, Belgium
University Colorado Cancer Center /ID# 269930

Aurora, Colorado, 80045-2517, United States
University of California Los Angeles /ID# 269969

Los Angeles, California, 90095-3075, United States
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 269926

Norfolk, Virginia, 23502, United States
Waterford Regional Hospital /ID# 269852

Waterford, X91 ER8E, Ireland
Women & Infants Hospital /ID# 269923

Providence, Rhode Island, 02905, United States
Women'S Cancer Care /ID# 269925

Covington, Louisiana, 70433, United States

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