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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 400 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | bevacizumab, mirvetuximab, chemotherapy |
| Locations | 86 sites (La Jolla, California and 85 other locations) |
| Status | Recruiting |
| Started | November 13, 2025 |
| Main results expected | January 2029 |
| Study ends | January 2029 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07059845 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
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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
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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
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.