Clinical trial Recruiting at 85 sites Phase 2 Interventional Ages 18 and up Women only

Mirvetuximab soravtansine combined with bevacizumab or carboplatin for FRα‑positive ovarian cancer

Official title: A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer

Run by AbbVie · NCT07059845 · Data updated 2026-11-12

This Phase 2 trial tests whether giving intravenous mirvetuximab soravtansine with bevacizumab or carboplatin is safe and can change disease activity in adults with folate receptor alpha (FRα)–positive high‑grade ovarian, fallopian tube, or primary peritoneal cancer.

More Ovarian Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment400 (estimated)
SponsorAbbVie
Industry-sponsored
Drugs / interventionsbevacizumab, mirvetuximab, chemotherapy
Locations86 sites (La Jolla, California and 85 other locations)
StatusRecruiting
StartedNovember 13, 2025
Main results expectedJanuary 2029
Study endsJanuary 2029
Registry record updatedOctober 13, 2026
Trial IDNCT07059845 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with high‑grade ovarian (or fallopian tube/primary peritoneal) cancer who are FRα‑positive by Ventana FOLR1, have ECOG performance status 0–1, and either are newly diagnosed FIGO stage III/IV HRP (substudy 1) or have platinum‑sensitive relapse after 1–2 prior platinum regimens (substudy 2).

Probably not a fit

Patients who are FRα‑negative, have ECOG ≥2, are platinum‑resistant, or do not meet the substudy‑specific criteria (for example HRD‑positive frontline disease) are unlikely to benefit from these treatment combinations.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

About 320 adults with medium or high FRα expression (by the Ventana FOLR1 assay) will be assigned to one of two substudies and into specific treatment arms. Substudy 1 compares two doses of mirvetuximab soravtansine plus bevacizumab versus bevacizumab alone in FIGO stage III/IV HRP patients, while substudy 2 gives two doses of mirvetuximab soravtansine with carboplatin followed by mirvetuximab soravtansine alone in platinum‑sensitive relapsed patients. Treatments are given intravenously and participants are monitored for adverse events and changes in disease activity. The trial enrolls at multiple international sites, including several Australian oncology centers.

Why it matters

Potential benefit: If successful, these combinations could provide a more effective targeted treatment option with manageable side effects for FRα‑positive ovarian cancer patients.

How similar studies have gone: Mirvetuximab soravtansine has shown single‑agent activity in other FRα‑positive ovarian cancer trials, but combining it with bevacizumab or carboplatin is still being tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • UC San Diego Health - Moores Cancer Center /ID# 277574
    La Jolla, California, United States
    Recruiting
  • University of Florida College of Medicine /ID# 278348
    Gainesville, Florida, United States
    Recruiting
  • Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623
    Orlando, Florida, United States
    Recruiting
  • Florida Cancer Specialists - North /ID# 278626
    St. Petersburg, Florida, United States
    Recruiting
  • Florida Cancer Specialists - East /ID# 278605
    West Palm Beach, Florida, United States
    Recruiting
  • Baptist Health Lexington /ID# 278267
    Lexington, Kentucky, United States
    Recruiting
Show 44 more locations
  • Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440
    Baton Rouge, Louisiana, United States
    Recruiting
  • Maine Medical Center - Scarborough Campus /ID# 277205
    Scarborough, Maine, United States
    Recruiting
  • UMass Memorial Medical Center - Belmont Street /ID# 278628
    Worcester, Massachusetts, United States
    Recruiting
  • Karmanos Cancer Institute - Detroit /ID# 277085
    Detroit, Michigan, United States
    Recruiting
  • Intermountain Health - Intermountain Health West End Clinic /ID# 278470
    Billings, Montana, United States
    Recruiting
  • Md Anderson Cancer Center At Cooper /ID# 278390
    Camden, New Jersey, United States
    Recruiting
  • Columbia University Medical Center /ID# 277990
    New York, New York, United States
    Recruiting
  • SUNY Upstate Medical University - Syracuse /ID# 277245
    Syracuse, New York, United States
    Recruiting
  • FirstHealth of the Carolinas- Speciality Center /ID# 278636
    Pinehurst, North Carolina, United States
    Recruiting
  • Jamescare Gynecologic Oncology At Mill Run /ID# 277951
    Hilliard, Ohio, United States
    Recruiting
  • Willamette Valley Cancer Institute and Research Center /ID# 277714
    Eugene, Oregon, United States
    Recruiting
  • Penn Medicine University of Pennsylvania Health System /ID# 277963
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Western Pennsylvania Gynecologic Oncology /ID# 278632
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • Avera Cancer Institute - Sioux Falls /ID# 278627
    Sioux Falls, South Dakota, United States
    Recruiting
  • University Of Tennessee Medical Center /ID# 278225
    Knoxville, Tennessee, United States
    Recruiting
  • Texas Oncology - Abilene - Antilley Road /ID# 277739
    Abilene, Texas, United States
    Recruiting
  • University of Texas - Southwestern Medical Center /ID# 278289
    Dallas, Texas, United States
    Recruiting
  • Texas Oncology - Fort Worth Cancer Center /ID# 277989
    Fort Worth, Texas, United States
    Recruiting
  • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735
    San Antonio, Texas, United States
    Recruiting
  • Texas Oncology - The Woodlands /ID# 277926
    The Woodlands, Texas, United States
    Recruiting
  • Texas Oncology - Northeast Texas /ID# 277737
    Tyler, Texas, United States
    Recruiting
  • Virginia Commonwealth University Medical Center /ID# 277932
    Richmond, Virginia, United States
    Recruiting
  • Virginia Mason Hospital and Medical Center /ID# 277259
    Seattle, Washington, United States
    Recruiting
  • West Virginia University Hospitals /ID# 278965
    Morgantown, West Virginia, United States
    Recruiting
  • St. George Private Hospital /ID# 276570
    Kogarah, New South Wales, Australia
    Recruiting
  • Chris O'Brien Lifehouse /ID# 276337
    Sydney, New South Wales, Australia
    Recruiting
  • Icon Cancer Centre Wesley /ID# 277199
    Auchenflower, Queensland, Australia
    Recruiting
  • Burnside War Memorial Hospital /ID# 277602
    Adelaide, South Australia, Australia
    Recruiting
  • Icon Cancer Centre Hobart /ID# 277688
    Hobart, Tasmania, Australia
    Recruiting
  • Monash Health - Monash Medical Centre - Clayton /ID# 276984
    Clayton, Victoria, Australia
    Recruiting
  • Barwon Health /ID# 277297
    Geelong, Victoria, Australia
    Recruiting
  • Austin Hospital /ID# 276534
    Melbourne, Victoria, Australia
    Recruiting
  • Epworth HealthCare /ID# 276347
    Richmond, Victoria, Australia
    Recruiting
  • St. John Of God Subiaco Hospital /ID# 277174
    Subiaco, Western Australia, Australia
    Recruiting
  • Cliniques Universitaires UCL Saint-Luc /ID# 276321
    Brussels, Brussels Capital, Belgium
    Recruiting
  • AZ Maria Middelares /ID# 276325
    Ghent, Oost-Vlaanderen, Belgium
    Recruiting
  • Universitair Ziekenhuis Leuven /ID# 276316
    Leuven, Vlaams-Brabant, Belgium
    Recruiting
  • CHU de Liege /ID# 276500
    Liège, Belgium
    Recruiting
  • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 277183
    Namur, Belgium
    Recruiting
  • Masarykuv Onkologicky Ustav /ID# 276080
    Brno, Brno-mesto, Czechia
    Recruiting
  • Vseobecna Fakultni nemocnice v Praze /ID# 276213
    Prague, Praha 17, Czechia
    Recruiting
  • Fakultni nemocnice Motol a Homolka /ID# 276300
    Prague, Praha 5, Czechia
    Recruiting
  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 276205
    Hradec Králové, Czechia
    Recruiting
  • Herlev Hospital /ID# 276831
    Herlev, Capital Region, Denmark
    Recruiting

+36 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.