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New hope for ovarian cancer: targeted drug combo enters Mid-Stage trial

NCT ID NCT07059845

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 11 times

Summary

This Phase 2 trial tests mirvetuximab soravtansine, a targeted drug, combined with standard chemotherapy (carboplatin) or bevacizumab in 400 people with a specific type of ovarian cancer (FRα-positive). The study aims to find the best dose and combination to shrink tumors and control the disease while monitoring side effects. Participants will receive intravenous infusions and be followed for about 40 months.

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 targeted drug) combined with carboplatin or bevacizumab
What this could lead to
If successful, this could lead to better treatment options for people with a specific type of ovarian cancer, potentially improving tumor shrinkage and delaying progression.
What could go wrong
This is a Phase 2 trial, so it's still early. The drug combinations may cause side effects like eye problems or other adverse events, and not all participants may benefit. Results may not apply to all ovarian cancer patients.

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

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2029

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: Substudy 1 * Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity. * Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. * 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. 2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased 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. * Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available. Substudy 2 * Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity. * Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. * Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. * Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy. * Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy. * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline. Substudy 3 * Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity. * Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. * Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. * Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy. * Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy. * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline. Exclusion Criteria: Substudy 1 * Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization. * Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization. * Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi). Substudy 2 * More than 2 prior lines of 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 (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently). * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen) * Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents. Substudy 3 * More than 2 prior lines of 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 (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently). * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen) * Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer malignant ovarian serous tumor ovarian cancer ovarian serous adenocarcinoma primary peritoneal carcinoma

As listed by the trial registrant

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

Ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    82 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Maria Middelares /ID# 276325

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Aalborg University Hospital /ID# 276435

    RECRUITING

    Aalborg, North Denmark, 9000, Denmark

  • Asan Medical Center /ID# 276955

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Austin Hospital /ID# 276534

    RECRUITING

    Melbourne, Victoria, 3084, Australia

  • Avera Cancer Institute - Sioux Falls /ID# 278627

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Baptist Health Lexington /ID# 278267

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Barwon Health /ID# 277297

    RECRUITING

    Geelong, Victoria, 3220, Australia

  • Burnside War Memorial Hospital /ID# 277602

    RECRUITING

    Adelaide, South Australia, 5065, Australia

  • CHU de Liege /ID# 276500

    RECRUITING

    Liège, 4000, Belgium

  • CHU de Limoges site CHU Dupuytren 1 /ID# 276851

    RECRUITING

    Limoges, New Aquitaine, 87000, France

  • Centre Antoine-Lacassagne /ID# 276708

    RECRUITING

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

  • Centre Francois Baclesse /ID# 276709

    RECRUITING

    Caen, Calvados, 14076, France

  • Centre Georges Francois Leclerc /ID# 276737

    RECRUITING

    Dijon, Bourgogne-Franche-Comté, 21079, France

  • Centre Leon Berard /ID# 276710

    RECRUITING

    Lyon, Rhone, 69373, France

  • Chris O'Brien Lifehouse /ID# 276337

    RECRUITING

    Sydney, New South Wales, 2050, Australia

  • Clinica Universidad de Navarra - Madrid /ID# 276411

    RECRUITING

    Madrid, 28027, Spain

  • Cliniques Universitaires UCL Saint-Luc /ID# 276321

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Complejo Hospitalario Universitario A Coruna /ID# 276416

    RECRUITING

    A Coruña, 15006, Spain

  • Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 276438

    RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

  • Epworth Hospital - Richmond /ID# 276347

    RECRUITING

    Richmond, Victoria, 3121, Australia

  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 276205

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Motol a Homolka /ID# 276300

    RECRUITING

    Prague, Praha 5, 150 06, Czechia

  • FirstHealth of the Carolinas- Speciality Center /ID# 278636

    RECRUITING

    Pinehurst, North Carolina, 28374, United States

  • Florida Cancer Specialists - East /ID# 278605

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists - North /ID# 278626

    RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Herlev Hospital /ID# 276831

    RECRUITING

    Herlev, Capital Region, 2730, Denmark

  • Hopital Prive Des Cotes D'Armor /ID# 276706

    RECRUITING

    Plérin, Cotes-d Armor, 22190, France

  • Hospital Clinic de Barcelona /ID# 276412

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos. /ID# 276407

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Clinico Universitario Lozano Blesa /ID# 276406

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitari Vall d Hebron /ID# 276478

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Donostia /ID# 276404

    RECRUITING

    Donostia / San Sebastian, Guipuzcoa, 20014, Spain

  • Hospital Universitario Marques de Valdecilla /ID# 276415

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 281304

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Virgen del Rocio /ID# 276426

    RECRUITING

    Seville, Sevilla, 41013, Spain

  • IUCT Oncopole /ID# 276705

    RECRUITING

    Toulouse, Occitanie, 31059, France

  • Icon Cancer Centre Hobart /ID# 277688

    RECRUITING

    Hobart, Tasmania, 7000, Australia

  • Icon Cancer Centre Wesley /ID# 277199

    RECRUITING

    Auchenflower, Queensland, 4066, Australia

  • Institut Bergonie /ID# 276696

    RECRUITING

    Bordeaux, Gironde, 33076, France

  • Institut Catala D Oncologia - Ico - Girona /ID# 276410

    RECRUITING

    Girona, 17007, Spain

  • Institut Curie -Site Saint-Cloud /ID# 276850

    RECRUITING

    Saint-Cloud, Hauts-de-Seine, 92210, France

  • Institut Godinot /ID# 276849

    RECRUITING

    Reims, Marne, 51726, France

  • Institut Gustave Roussy /ID# 276712

    RECRUITING

    Villejuif, Île-de-France Region, 94800, France

  • Institut du Cancer Avignon Provence - Sainte Catherine /ID# 276692

    RECRUITING

    Avignon, Vaucluse, 84918, France

  • Instituto Valenciano de Oncologia /ID# 276413

    RECRUITING

    Valencia, 46009, Spain

  • Intermountain Health - Intermountain Health West End Clinic /ID# 278470

    RECRUITING

    Billings, Montana, 59106, United States

  • Jamescare Gynecologic Oncology At Mill Run /ID# 277951

    RECRUITING

    Hilliard, Ohio, 43026, United States

  • Karmanos Cancer Institute - Detroit /ID# 277085

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Korea University Guro Hospital /ID# 276194

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 08308, South Korea

  • Maine Medical Center - Scarborough Campus /ID# 277205

    RECRUITING

    Scarborough, Maine, 04074, United States

  • Masarykuv Onkologicky Ustav /ID# 276080

    RECRUITING

    Brno, Brno-mesto, 656 53, Czechia

  • Md Anderson Cancer Center At Cooper /ID# 278390

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Monash Health - Monash Medical Centre - Clayton /ID# 276984

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • National Cancer Center /ID# 276283

    RECRUITING

    Goyang-si, Gyeonggido, 10408, South Korea

  • Odense University Hospital /ID# 276462

    RECRUITING

    Odense, Region Syddanmark, 5000, Denmark

  • Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623

    RECRUITING

    Orlando, Florida, 32806, United States

  • Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440

    RECRUITING

    Baton Rouge, Louisiana, 70817, United States

  • Penn Medicine University of Pennsylvania Health System /ID# 277963

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • SUNY Upstate Medical University - Syracuse /ID# 277245

    RECRUITING

    Syracuse, New York, 13210, United States

  • Samsung Medical Center /ID# 276261

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Sansum Clinic - Solvang /ID# 277712

    ACTIVE_NOT_RECRUITING

    Solvang, California, 93463, United States

  • Seoul National University Bundang Hospital /ID# 276280

    RECRUITING

    Seongnam-si, Gyeonggido, 13620, South Korea

  • Seoul National University Hospital /ID# 276182

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • St. George Private Hospital /ID# 276570

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • St. John Of God Subiaco Hospital /ID# 277174

    RECRUITING

    Subiaco, Western Australia, 6008, Australia

  • Strasbourg Oncologie Liberale /ID# 276698

    RECRUITING

    Strasbourg, Bas-Rhin, 67000, France

  • Texas Oncology - Abilene - Antilley Road /ID# 277739

    RECRUITING

    Abilene, Texas, 79606, United States

  • Texas Oncology - Fort Worth Cancer Center /ID# 277989

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Texas Oncology - Northeast Texas /ID# 277737

    RECRUITING

    Tyler, Texas, 75702, United States

  • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Texas Oncology - The Woodlands /ID# 277926

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • UC San Diego Health - Moores Cancer Center /ID# 277574

    RECRUITING

    La Jolla, California, 92037, United States

  • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 277183

    RECRUITING

    Namur, 5000, Belgium

  • UMass Memorial Medical Center - Belmont Street /ID# 278628

    RECRUITING

    Worcester, Massachusetts, 01605, United States

  • Universitair Ziekenhuis Leuven /ID# 276316

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University Of Tennessee Medical Center /ID# 278225

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • University of Florida College of Medicine /ID# 278348

    RECRUITING

    Gainesville, Florida, 32610, United States

  • Virginia Mason Hospital and Medical Center /ID# 277259

    RECRUITING

    Seattle, Washington, 98101, United States

  • Vseobecna Fakultni nemocnice v Praze /ID# 276213

    RECRUITING

    Prague, Praha 17, 128 00, Czechia

  • West Virginia University Hospitals /ID# 278965

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Western Pennsylvania Gynecologic Oncology /ID# 278632

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Willamette Valley Cancer Institute and Research Center /ID# 277714

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Yonsei University Health System Severance Hospital /ID# 276266

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

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