NCT07059845RecruitingPhase 2
A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay. Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world. Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 2 Jul 2025
- Start date
- 13 Nov 2025
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- AbbVie
- Diseases
- Ovarian cancer
- NCT number
- NCT07059845
- EU CT number
- 2025-521606-18-00
- EudraCT number
- 2025-521606-18
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 400
- From 13 Nov 2025 to the primary completion date, 31 Jan 2029
- 87 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.
Other
- Substudy 1
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (87)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Burnside War Memorial Hospital /ID# 277602 Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Icon Cancer Centre Wesley /ID# 277199 Coordinator of this site? Confirm its status | Auchenflower | Australia | Recruiting |
| Monash Health - Monash Medical Centre - Clayton /ID# 276984 Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Barwon Health /ID# 277297 Coordinator of this site? Confirm its status | Geelong | Australia | Recruiting |
| Icon Cancer Centre Hobart /ID# 277688 Coordinator of this site? Confirm its status | Hobart | Australia | Recruiting |
| St. George Private Hospital /ID# 276570 Coordinator of this site? Confirm its status | Kogarah | Australia | Recruiting |
| Austin Hospital /ID# 276534 Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Epworth HealthCare /ID# 276347 Coordinator of this site? Confirm its status | Richmond | Australia | Recruiting |
| St. John Of God Subiaco Hospital /ID# 277174 Coordinator of this site? Confirm its status | Subiaco | Australia | Recruiting |
| Chris O'Brien Lifehouse /ID# 276337 Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Namur | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Masarykuv Onkologicky Ustav Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Fakultni Nemocnice Motol a Homolka Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Complexo Hospitalario Universitario A Coruña (CHUAC) Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Institut Català d'Oncologia Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Sainte Catherine Institut Du Cancer Avignon-Provence Coordinator of this site? Confirm its status | Avignon Cedex 9 | France | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Hospitalier Et Universitaire de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Recruiting |
| Hôpital Privé des Côtes d'Armor Coordinator of this site? Confirm its status | Plérin | France | Recruiting |
| Institut Godinot Coordinator of this site? Confirm its status | Reims | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Saint-Cloud | France | Recruiting |
| Groupe Hospitalier Saint Vincent Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| National Cancer Center /ID# 276283 Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| Seoul National University Bundang Hospital /ID# 276280 Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Yonsei University Health System - Severance Hospital /ID# 276266 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital /ID# 276194 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center /ID# 276955 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital /ID# 276182 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center /ID# 276261 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Texas Oncology - Abilene - Antilley Road /ID# 277739 Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440 Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| Intermountain Health - Intermountain Health West End Clinic /ID# 278470 Coordinator of this site? Confirm its status | Billings | United States | Recruiting |
| Md Anderson Cancer Center At Cooper /ID# 278390 Coordinator of this site? Confirm its status | Camden | United States | Recruiting |
| University of Texas - Southwestern Medical Center /ID# 278289 Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Karmanos Cancer Institute - Detroit /ID# 277085 Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Willamette Valley Cancer Institute and Research Center /ID# 277714 Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| Texas Oncology - Fort Worth Cancer Center /ID# 277989 Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| University of Florida College of Medicine /ID# 278348 Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Jamescare Gynecologic Oncology At Mill Run /ID# 277951 Coordinator of this site? Confirm its status | Hilliard | United States | Recruiting |
| University Of Tennessee Medical Center /ID# 278225 Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| UC San Diego Health - Moores Cancer Center /ID# 277574 Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Baptist Health Lexington /ID# 278267 Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| West Virginia University Hospitals /ID# 278965 Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| Columbia University Medical Center /ID# 277990 Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623 Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Penn Medicine University of Pennsylvania Health System /ID# 277963 Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| FirstHealth of the Carolinas- Speciality Center /ID# 278636 Coordinator of this site? Confirm its status | Pinehurst | United States | Recruiting |
| Western Pennsylvania Gynecologic Oncology /ID# 278632 Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Virginia Commonwealth University Medical Center /ID# 277932 Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735 Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Maine Medical Center - Scarborough Campus /ID# 277205 Coordinator of this site? Confirm its status | Scarborough | United States | Recruiting |
| Virginia Mason Hospital and Medical Center /ID# 277259 Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Avera Cancer Institute - Sioux Falls /ID# 278627 Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Sansum Clinic - Solvang /ID# 277712 Coordinator of this site? Confirm its status | Solvang | United States | Active, not recruiting |
| Florida Cancer Specialists - North /ID# 278626 Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| SUNY Upstate Medical University - Syracuse /ID# 277245 Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Texas Oncology - The Woodlands /ID# 277926 Coordinator of this site? Confirm its status | The Woodlands | United States | Recruiting |
| Texas Oncology - Northeast Texas /ID# 277737 Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| Florida Cancer Specialists - East /ID# 278605 Coordinator of this site? Confirm its status | West Palm Beach | United States | Recruiting |
| UMass Memorial Medical Center - Belmont Street /ID# 278628 Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.