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
FLORENZA
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
2 other identifiers
interventional
400
8 countries
80
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Nov 2025
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2025
CompletedFirst Posted
Study publicly available on registry
July 11, 2025
CompletedStudy Start
First participant enrolled
November 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
July 30, 2026
July 1, 2026
3.1 years
July 2, 2025
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Substudy 1, 2, and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3)
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
Up to Approximately 40 Months
Substudy 1, 2, and 3: Number of Participants with TEAEs Leading to Discontinuation
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
Up to Approximately 40 Months
Substudy 1, 2, and 3: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to Approximately 40 Months
Substudy 1, 2, and 3: Overall Response (OR) as Assessed by the Investigator per RECIST v1.1
OR is defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to Approximately 40 Months
Substudy 1: Progression free survival (PFS) as Assessed by the Investigator per RECIST v1.1
PFS is defined as the time from the date of randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause, whichever occurs first.
Up to Approximately 40 Months
Secondary Outcomes (5)
Substudy 1, 2, and 3: CA-125 Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Up to Approximately 40 Months
Substudy 1, 2, and 3: Duration of Response (DOR) as Assessed by the Investigator per RECIST v1.1
Up to Approximately 40 Months
Substudy 1, 2, and 3: Number of Participants with Peripheral Neuropathy AEs (any grade, Grade ≥ 2)
Up to Approximately 40 Months
Substudy 1, 2, and 3: Number of Participants with Adjudicated Pneumonitis/ Interstitial Lung Disease (ILD) (any grade)
Up to Approximately 40 Months
Substudy 2 and 3: PFS as Assessed by the Investigator per RECIST v1.1
Up to Approximately 40 Months
Study Arms (7)
Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A
EXPERIMENTALParticipants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration.
Substudy 1 Arm B: MIRV Dose B
EXPERIMENTALParticipants will receive dose B of MIRV with Bev, as part of the approximately 40 month study duration.
Substudy 1 Arm C: Bev
EXPERIMENTALParticipants will receive Bev, as part of the approximately 40 month study duration.
Substudy 2 Arm D: MIRV Dose A
EXPERIMENTALParticipants will receive dose A of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.
Substudy 2 Arm E: MIRV Dose B
EXPERIMENTALParticipants will receive dose B of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.
Substudy 3 Arm F: MIRV Dose A
EXPERIMENTALParticipants will receive dose A of MIRV with BEV and carboplatin, followed by MIRV at a lower dose with BEV, as part of the approximately 31 month study duration.
Substudy 3 Arm G: MIRV Dose B
EXPERIMENTALParticipants will receive dose B of MIRV with BEV and carboplatin, followed by MIRV at the same dose with BEV, as part of the approximately 31 month study duration.
Interventions
Intravenous (IV) infusion
IV Infusion
IV Infusion
Eligibility Criteria
You may qualify if:
- 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.
- L 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.
- L 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.
- +5 more criteria
You may not qualify if:
- 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).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (80)
UC San Diego Health - Moores Cancer Center /ID# 277574
La Jolla, California, 92037, United States
Sansum Clinic - Solvang /ID# 277712
Solvang, California, 93463, United States
University of Florida College of Medicine /ID# 278348
Gainesville, Florida, 32610, United States
Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623
Orlando, Florida, 32806, United States
Florida Cancer Specialists - North /ID# 278626
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - East /ID# 278605
West Palm Beach, Florida, 33401, United States
Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440
Baton Rouge, Louisiana, 70817, United States
Maine Medical Center - Scarborough Campus /ID# 277205
Scarborough, Maine, 04074, United States
Karmanos Cancer Institute - Detroit /ID# 277085
Detroit, Michigan, 48201, United States
Intermountain Health - Intermountain Health West End Clinic /ID# 278470
Billings, Montana, 59106, United States
Md Anderson Cancer Center At Cooper /ID# 278390
Camden, New Jersey, 08103, United States
SUNY Upstate Medical University - Syracuse /ID# 277245
Syracuse, New York, 13210, United States
FirstHealth of the Carolinas- Speciality Center /ID# 278636
Pinehurst, North Carolina, 28374, United States
Jamescare Gynecologic Oncology At Mill Run /ID# 277951
Hilliard, Ohio, 43026, United States
Willamette Valley Cancer Institute and Research Center /ID# 277714
Eugene, Oregon, 97401, United States
Penn Medicine University of Pennsylvania Health System /ID# 277963
Philadelphia, Pennsylvania, 19104, United States
Western Pennsylvania Gynecologic Oncology /ID# 278632
Pittsburgh, Pennsylvania, 15224, United States
Avera Cancer Institute - Sioux Falls /ID# 278627
Sioux Falls, South Dakota, 57105, United States
University Of Tennessee Medical Center /ID# 278225
Knoxville, Tennessee, 37920, United States
Texas Oncology - Abilene - Antilley Road /ID# 277739
Abilene, Texas, 79606, United States
Texas Oncology - Fort Worth Cancer Center /ID# 277989
Fort Worth, Texas, 76104, United States
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735
San Antonio, Texas, 78240, United States
Texas Oncology - The Woodlands /ID# 277926
The Woodlands, Texas, 77380, United States
Texas Oncology - Northeast Texas /ID# 277737
Tyler, Texas, 75702, United States
Virginia Mason Hospital and Medical Center /ID# 277259
Seattle, Washington, 98101, United States
West Virginia University Hospitals /ID# 278965
Morgantown, West Virginia, 26506, United States
St. George Private Hospital /ID# 276570
Kogarah, New South Wales, 2217, Australia
Chris O'Brien Lifehouse /ID# 276337
Sydney, New South Wales, 2050, Australia
Icon Cancer Centre Wesley /ID# 277199
Auchenflower, Queensland, 4066, Australia
Burnside War Memorial Hospital /ID# 277602
Adelaide, South Australia, 5065, Australia
Icon Cancer Centre Hobart /ID# 277688
Hobart, Tasmania, 7000, Australia
Monash Health - Monash Medical Centre - Clayton /ID# 276984
Clayton, Victoria, 3168, Australia
Barwon Health /ID# 277297
Geelong, Victoria, 3220, Australia
Austin Hospital /ID# 276534
Melbourne, Victoria, 3084, Australia
Epworth Hospital - Richmond /ID# 276347
Richmond, Victoria, 3121, Australia
St. John Of God Subiaco Hospital /ID# 277174
Subiaco, Western Australia, 6008, Australia
Cliniques Universitaires UCL Saint-Luc /ID# 276321
Brussels, Brussels Capital, 1200, Belgium
AZ Maria Middelares /ID# 276325
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 276316
Leuven, Vlaams-Brabant, 3000, Belgium
CHU de Liege /ID# 276500
Liège, 4000, Belgium
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 277183
Namur, 5000, Belgium
Masarykuv Onkologicky Ustav /ID# 276080
Brno, Brno-mesto, 656 53, Czechia
Vseobecna Fakultni nemocnice v Praze /ID# 276213
Prague, Praha 17, 128 00, Czechia
Fakultni nemocnice Motol a Homolka /ID# 276300
Prague, Praha 5, 150 06, Czechia
Fakultni nemocnice Hradec Kralove - Sokolska /ID# 276205
Hradec Králové, 500 05, Czechia
Herlev Hospital /ID# 276831
Herlev, Capital Region, 2730, Denmark
Aalborg University Hospital /ID# 276435
Aalborg, North Denmark, 9000, Denmark
Odense University Hospital /ID# 276462
Odense, Region Syddanmark, 5000, Denmark
Strasbourg Oncologie Liberale /ID# 276698
Strasbourg, Bas-Rhin, 67000, France
Centre Georges Francois Leclerc /ID# 276737
Dijon, Bourgogne-Franche-Comté, 21079, France
Centre Francois Baclesse /ID# 276709
Caen, Calvados, 14076, France
Hopital Prive Des Cotes D'Armor /ID# 276706
Plérin, Cotes-d Armor, 22190, France
Institut Bergonie /ID# 276696
Bordeaux, Gironde, 33076, France
Institut Curie -Site Saint-Cloud /ID# 276850
Saint-Cloud, Hauts-de-Seine, 92210, France
Institut Godinot /ID# 276849
Reims, Marne, 51726, France
CHU de Limoges site CHU Dupuytren 1 /ID# 276851
Limoges, New Aquitaine, 87000, France
IUCT Oncopole /ID# 276705
Toulouse, Occitanie, 31059, France
Centre Antoine-Lacassagne /ID# 276708
Nice, Provence-Alpes-Côte d'Azur Region, 06189, France
Centre Leon Berard /ID# 276710
Lyon, Rhone, 69373, France
Institut du Cancer Avignon Provence - Sainte Catherine /ID# 276692
Avignon, Vaucluse, 84918, France
Institut Gustave Roussy /ID# 276712
Villejuif, Île-de-France Region, 94800, France
National Cancer Center /ID# 276283
Goyang-si, Gyeonggido, 10408, South Korea
Seoul National University Bundang Hospital /ID# 276280
Seongnam-si, Gyeonggido, 13620, South Korea
Seoul National University Hospital /ID# 276182
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Yonsei University Health System Severance Hospital /ID# 276266
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Asan Medical Center /ID# 276955
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 276261
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Korea University Guro Hospital /ID# 276194
Seoul, Seoul Teugbyeolsi, 08308, South Korea
Hospital Universitario Marques de Valdecilla /ID# 276415
Santander, Cantabria, 39008, Spain
Hospital Universitario Donostia /ID# 276404
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 276438
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario Virgen del Rocio /ID# 276426
Seville, Sevilla, 41013, Spain
Complejo Hospitalario Universitario A Coruna /ID# 276416
A Coruña, 15006, Spain
Hospital Universitari Vall d Hebron /ID# 276478
Barcelona, 08035, Spain
Hospital Clinic de Barcelona /ID# 276412
Barcelona, 08036, Spain
Institut Catala D Oncologia - Ico - Girona /ID# 276410
Girona, 17007, Spain
Clinica Universidad de Navarra - Madrid /ID# 276411
Madrid, 28027, Spain
Hospital Clinico San Carlos. /ID# 276407
Madrid, 28040, Spain
Instituto Valenciano de Oncologia /ID# 276413
Valencia, 46009, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 276406
Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2025
First Posted
July 11, 2025
Study Start
November 13, 2025
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.