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Advanced High-Grade Epithelial Ovarian CancerPhase 2NCT06682988

A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine

A Phase 2 study testing Mirvetuximab Soravtansine in people with Advanced High-Grade Epithelial Ovarian Cancer and Primary Peritoneal Cancer, run by AbbVie at 52 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mirvetuximab Soravtansine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
52 sitesin 8 countries
Study dates
28 May 2025to Apr 2028
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

  • Both Cohorts
  • Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
  • Participants with platinum-resistant disease:
  • Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between > 3 months and ≤ 6 months after the date of the last dose of platinum.
  • Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum.
  • Participants with progression diagnosed radiographically on or after their most recent line of therapy.
Show all 9Show fewer
  • Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
  • Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).

Who cannot join

  • Both Cohorts
  • Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
  • Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy.
  • Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol
  • Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.

Trial locations and contacts

52 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

52 sites in 8 countries

Spain11 sites, 11 recruiting

  • Hospital Universitario Germans Trias i Pujol /ID# 272216

    Badalona, Barcelona, 08916

    Recruiting

  • Hospital Universitario Vall de Hebron /ID# 272134

    Barcelona, 08035

    Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca /ID# 272223

    El Palmar, Murcia, 30120

    Recruiting

  • Hospital Universitario de Jaén /ID# 272205

    Jaén, Jaen, 23007

    Recruiting

  • Hospital General Universitario Gregorio Maranon /ID# 272121

    Madrid, 28007

    Recruiting

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 272221

    Madrid, 28027

    Recruiting

  • Hospital Universitario HM Sanchinarro /ID# 272190

    Madrid, 28050

    Recruiting

  • Clinica Universidad de Navarra - Pamplona /ID# 275742

    Pamplona, Navarre, 31008

    Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 272107

    Seville, Sevilla, 41013

    Recruiting

  • Hospital Clinico Universitario de Valencia /ID# 272218

    Valencia, 46010

    Recruiting

  • Hospital Clinico Universitario Lozano Blesa /ID# 272165

    Zaragoza, 50009

    Recruiting

Other trials in Spain

South Korea9 sites, 9 recruiting

  • Keimyung University Dongsan Hospital /ID# 271592

    Daegu, Gyeongsangbuk-do, 42601

    Recruiting

  • National Cancer Center /ID# 272265

    Goyang-si, Gyeonggido, 10408

    Recruiting

  • CHA Bundang Medical Center /ID# 271590

    Seongnam, Gyeonggido, 13496

    Recruiting

  • Seoul National University Bundang Hospital /ID# 271594

    Seongnam-si, Gyeonggido, 13620

    Recruiting

  • Seoul National University Hospital /ID# 272264

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Yonsei University Health System Severance Hospital /ID# 271593

    Seoul, Seoul Teugbyeolsi, 03722

    Recruiting

  • Asan Medical Center /ID# 272130

    Seoul, Seoul Teugbyeolsi, 05505

    Recruiting

  • Gangnam Severance Hospital /ID# 272217

    Seoul, Seoul Teugbyeolsi, 06273

    Recruiting

  • Samsung Medical Center /ID# 271591

    Seoul, Seoul Teugbyeolsi, 06351

    Recruiting

Other trials in South Korea

France8 sites, 8 recruiting

  • Centre Francois Baclesse /ID# 272204

    Caen, Calvados, 14076

    Recruiting

  • Centre Hospitalier Departemental Vendee (Chd Vendee) /ID# 272174

    La Roche-sur-Yon, Vendee, 85925

    Recruiting

  • Centre Oscar Lambret /ID# 272183

    Lille, Nord, 59000

    Recruiting

  • Centre Antoine-Lacassagne /ID# 272101

    Nice, Provence-Alpes-Côte d'Azur Region, 06189

    Recruiting

  • GH Diaconesses Croix Saint Simon-Hopital De La Croix Saint-Simon /ID# 272179

    Paris, 75020

    Recruiting

  • HCL - Hopital Lyon Sud /ID# 272178

    Pierre-Bénite, Rhone, 69495

    Recruiting

  • Centre Armoricain De Radiothérapie, D'Imagerie Médicale Et D'Oncologie (Cario) /ID# 272201

    Plérin, Cotes-d Armor, 22190

    Recruiting

  • Institut De Cancérologie De Lorraine Alexis Vautrin /ID# 272147

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54519

    Recruiting

Other trials in France

United States7 sites, 7 recruiting

  • Karmanos Cancer Institute - Detroit /ID# 272112

    Detroit, Michigan, 48201

    Recruiting

  • St. Elizabeth Medical Center - Edgewood /ID# 272113

    Edgewood, Kentucky, 41017

    Recruiting

  • Memorial Hermann Texas Medical Center /ID# 272227

    Houston, Texas, 77030

    Recruiting

  • Baptist Health Lexington /ID# 272211

    Lexington, Kentucky, 40503

    Recruiting

  • Allegheny Health Network West Penn Hospital /ID# 272267

    Pittsburgh, Pennsylvania, 15244

    Recruiting

  • First Physicians Group /ID# 272180

    Sarasota, Florida, 34239

    Recruiting

  • UMass Memorial Medical Center - Belmont Street /ID# 272122

    Worcester, Massachusetts, 01605

    Recruiting

Other trials in United States

Australia7 sites, 7 recruiting

  • Ballarat Base Hospital /ID# 272240

    Ballarat, Victoria, 3350

    Recruiting

  • Blacktown Hospital /ID# 272182

    Blacktown, New South Wales, 2148

    Recruiting

  • Royal Brisbane and Women's Hospital /ID# 272123

    Brisbane, Queensland, 4029

    Recruiting

  • Icon Cancer Centre Chermside /ID# 272220

    Chermside, Queensland, 4032

    Recruiting

  • Monash Health - Monash Medical Centre - Clayton /ID# 272234

    Clayton, Victoria, 3168

    Recruiting

  • Newcastle Private Hosptial /ID# 272213

    Lambton Heights, New South Wales, 2305

    Recruiting

  • Sir Charles Gairdner Hospital /ID# 272116

    Nedlands, Western Australia, 6009

    Recruiting

Other trials in Australia

Belgium5 sites, 5 recruiting

  • Algemeen Ziekenhuis klina /ID# 272127

    Brasschaat, Antwerpen, 2930

    Recruiting

  • Cliniques Universitaires UCL Saint-Luc /ID# 272219

    Brussels, Brussels Capital, 1200

    Recruiting

  • AZ Maria Middelares /ID# 272186

    Ghent, Oost-Vlaanderen, 9000

    Recruiting

  • Universitair Ziekenhuis Leuven /ID# 277350

    Leuven, Vlaams-Brabant, 3000

    Recruiting

  • AZ-Delta /ID# 272250

    Roeselare, West-Vlaanderen, 8800

    Recruiting

Other trials in Belgium

United Kingdom3 sites, 3 recruiting

  • Addenbrookes Hospital /ID# 272162

    Cambridge, Cambridgeshire, CB2 2QQ

    Recruiting

  • Royal Devon and Exeter Hospital /ID# 272170

    Exeter, Devon, EX2 5DW

    Recruiting

  • University College London Hospital /ID# 272115

    London, Greater London, NW1 2BU

    Recruiting

Other trials in United Kingdom

Poland2 sites, 2 recruiting

  • Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku /ID# 272169

    Bialystok, Podlaskie Voivodeship, 15-027

    Recruiting

  • Mazowiecki Szpital Wojewodzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. /ID# 271692

    Siedlce, Masovian Voivodeship, 08-110

    Recruiting

Other trials in Poland

About this study

Official title: A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα).

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 cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide.

Read more

The total study duration will be approximately 24 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Being tested
Mirvetuximab Soravtansine
Keywords
Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, Fallopian Tube Cancers, High Folate Receptor-Alpha Expression, Platinum Resistant, Mirvetuximab Soravtansine, MIRV, IMGN853
Medical subject headings
Fallopian Tube 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, IMGN853

    intravenous (IV) infusion

Study groups in NCT06682988
Study groupRoleWhat they receive
Randomized Phase 2 Cohort: Arm AExperimentalParticipants will receive Mirvetuximab Soravtansine at the standard dose on Day 1 of a 21-day cycle.
Receives: Drug: Mirvetuximab Soravtansine
Randomized Phase 2 Cohort: Arm BExperimentalParticipants will receive Mirvetuximab Soravtansine at a lower dose than the standard dose on Day 1 and Day 15 of a 28-day cycle .
Receives: Drug: Mirvetuximab Soravtansine
Hepatic Impairment Cohort : Mirvetuximab SoravtansineExperimentalParticipants will receive Mirvetuximab Soravtansine on Day 1 of a 21-day cycle. Different doses will be given to groups of patients to identify a safe and effective dose.
Receives: Drug: Mirvetuximab Soravtansine

What is being measured

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

  1. Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs)

    An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.

    Measured: Up to Approximately 24 months

  2. Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR)

    ORR is defined as best response of confirmed complete response (CR) or partial response (PR), as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Measured: Up to Approximately 24 months

  3. Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine

    Cmax of MIRV

    Measured: Up to Approximately 24 months

  4. Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine

    AUC of MIRV

    Measured: Up to Approximately 24 months

  5. Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine

    Ctrough of MIRV

    Measured: Up to Approximately 24 months

  6. Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine

    Vss) of MIRV

    Measured: Up to Approximately 24 months

  7. Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine

    Tmax of MIRV

    Measured: Up to Approximately 24 months

  8. Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine

    t1/2 of MIRV

    Measured: Up to Approximately 24 months

Secondary outcomes (15)

  1. Randomized Phase 2 Cohort: Percentage of Participants with Treatment-Emergent All-Grade Ocular AEs, Grade >= 2 Peripheral Neuropathy, All-Grade Infusion Reactions, and All-Grade Pneumonitis

    An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.

    Measured: Up to Approximately 24 months

  2. Randomized Phase 2 Cohort: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

    Defined as the time from initial investigator-assessed response (complete response (CR) or partial response (PR)) until progressive disease (PD) as assessed by the investigator or death, whichever occurs first.

    Measured: Up to Approximately 24 months

  3. Randomized Phase 2 Cohort: Progression-Free Survival (PFS)

    PFS is defined as the time from date of randomization until disease progression or death whichever occurs first.

    Measured: Up to Approximately 24 months

  4. Randomized Phase 2 Cohort: Overall Survival (OS)

    Overall survival is defined as the time from the date of first dose until the date of death from any cause.

    Measured: Up to Approximately 24 months

  5. Randomized Phase 2 Cohort: Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria

    The GCIG CA-125 response is defined as at least 50% reduction in CA-125 levels from baseline. The response must be confirmed and maintained for at least 28 days.

    Measured: Up to Approximately 24 months

  6. Randomized Phase 2 Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine

    Cmax of MIRV

    Measured: Up to Approximately 24 months

  7. Randomized Phase 2 Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine

    (AUC) of MIRV

    Measured: Up to Approximately 24 months

  8. Randomized Phase 2 Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine

    Ctrough of MIRV

    Measured: Up to Approximately 24 months

  9. Randomized Phase 2 Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine

    Vss of MIRV

    Measured: Up to Approximately 24 months

  10. Randomized Phase 2 Cohort: Time to Maximal Observed Concentration (Tmax) of Mirvetuximab Soravtansine

    Tmax of MIRV

    Measured: Up to Approximately 24 months

  11. Randomized Phase 2 Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine

    t1/2 of MIRV

    Measured: Up to Approximately 24 months

  12. Both Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.

    Measured: Up to Approximately 24 months

  13. Both Cohorts: Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator

    Vital signs include blood pressure, heart rate, respiratory rate, and body temperature.

    Measured: Up to Approximately 24 months

  14. Both Cohorts: Percentage of Participants with Clinically Significant Laboratory Values (test) as Assessed by the Investigator

    Percentage of participants with clinically significant laboratory values (hematology, chemistry, and coagulation) as assessed by the investigator.

    Measured: Up to Approximately 24 months

  15. Both Cohorts: Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings

    Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system.

    Measured: Up to Approximately 24 months

Timeline

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

  1. First posted12 Nov 2024
  2. Study start28 May 2025
  3. Primary completionJul 2026 (estimated)
  4. Study completionApr 2028 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06682988
Sponsor's protocol ID
IMGN853-0425
Other IDs
2024-517184-23-00
Status last verified
May 2026
First submitted
8 Nov 2024
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirvetuximab Soravtansine in people with Advanced High-Grade Epithelial Ovarian Cancer and Primary Peritoneal Cancer, run by AbbVie at 52 sites in 8 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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Spain, South Korea, France, United States, Australia and 3 more countries. 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?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs) (time frame: Up to Approximately 24 months). The study lists 8 primary outcomes in all. 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 NCT06682988.

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 26 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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