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Ovarian CancerPhase 2FLORENZANCT07059845

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 study testing Mirvetuximab Soravtansine, Bevacizumab and Carboplatin in people with Ovarian Cancer, run by AbbVie at 86 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Mirvetuximab Soravtansine, Bevacizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
86 sitesin 8 countries
Study dates
13 Nov 2025to Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
Show all 18Show fewer
  • 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.

Trial locations and contacts

86 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

86 sites in 8 countries

United States31 sites, 30 recruiting

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

    Abilene, Texas, 79606

    Recruiting

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

    Baton Rouge, Louisiana, 70817

    Recruiting

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

    Billings, Montana, 59106

    Recruiting

  • Md Anderson Cancer Center At Cooper /ID# 278390

    Camden, New Jersey, 08103

    Recruiting

  • University of Texas - Southwestern Medical Center /ID# 278289

    Dallas, Texas, 75235

    Recruiting

  • Karmanos Cancer Institute - Detroit /ID# 277085

    Detroit, Michigan, 48201

    Recruiting

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

    Eugene, Oregon, 97401

    Recruiting

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

    Fort Worth, Texas, 76104

    Recruiting

  • University of Florida College of Medicine /ID# 278348

    Gainesville, Florida, 32610

    Recruiting

  • Jamescare Gynecologic Oncology At Mill Run /ID# 277951

    Hilliard, Ohio, 43026

    Recruiting

  • University Of Tennessee Medical Center /ID# 278225

    Knoxville, Tennessee, 37920

    Recruiting

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

    La Jolla, California, 92037

    Recruiting

  • Baptist Health Lexington /ID# 278267

    Lexington, Kentucky, 40503

    Recruiting

  • West Virginia University Hospitals /ID# 278965

    Morgantown, West Virginia, 26506

    Recruiting

  • Columbia University Medical Center /ID# 277990

    New York, New York, 10032

    Recruiting

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

    Orlando, Florida, 32806

    Recruiting

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

    Philadelphia, Pennsylvania, 19104

    Recruiting

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

    Pinehurst, North Carolina, 28374

    Recruiting

  • Western Pennsylvania Gynecologic Oncology /ID# 278632

    Pittsburgh, Pennsylvania, 15224

    Recruiting

  • Virginia Commonwealth University Medical Center /ID# 277932

    Richmond, Virginia, 23219

    Recruiting

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

    San Antonio, Texas, 78240

    Recruiting

  • Maine Medical Center - Scarborough Campus /ID# 277205

    Scarborough, Maine, 04074

    Recruiting

  • Virginia Mason Hospital and Medical Center /ID# 277259

    Seattle, Washington, 98101

    Recruiting

  • Avera Cancer Institute - Sioux Falls /ID# 278627

    Sioux Falls, South Dakota, 57105

    Recruiting

  • Sansum Clinic - Solvang /ID# 277712

    Solvang, California, 93463

    Active, not recruiting

  • Florida Cancer Specialists - North /ID# 278626

    St. Petersburg, Florida, 33705

    Recruiting

  • SUNY Upstate Medical University - Syracuse /ID# 277245

    Syracuse, New York, 13210

    Recruiting

  • Texas Oncology - The Woodlands /ID# 277926

    The Woodlands, Texas, 77380

    Recruiting

  • Texas Oncology - Northeast Texas /ID# 277737

    Tyler, Texas, 75702

    Recruiting

  • Florida Cancer Specialists - East /ID# 278605

    West Palm Beach, Florida, 33401

    Recruiting

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

    Worcester, Massachusetts, 01605

    Recruiting

Other trials in United States

France13 sites, 13 recruiting

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

    Avignon, Vaucluse, 84918

    Recruiting

  • Institut Bergonie /ID# 276696

    Bordeaux, Gironde, 33076

    Recruiting

  • Centre Francois Baclesse /ID# 276709

    Caen, Calvados, 14076

    Recruiting

  • Centre Georges Francois Leclerc /ID# 276737

    Dijon, Bourgogne-Franche-Comté, 21079

    Recruiting

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

    Limoges, New Aquitaine, 87000

    Recruiting

  • Centre Leon Berard /ID# 276710

    Lyon, Rhone, 69373

    Recruiting

  • Centre Antoine-Lacassagne /ID# 276708

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

    Recruiting

  • Centre Armoricain De Radiotherapie D Imagerie Medicale Et D Oncologie - Cario /ID# 276706

    Plérin, Cotes-d Armor, 22190

    Recruiting

  • Institut Godinot /ID# 276849

    Reims, Marne, 51726

    Recruiting

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

    Saint-Cloud, Hauts-de-Seine, 92210

    Recruiting

  • Strasbourg Oncologie Liberale /ID# 276698

    Strasbourg, Bas-Rhin, 67000

    Recruiting

  • IUCT Oncopole /ID# 276705

    Toulouse, Occitanie, 31059

    Recruiting

  • Institut Gustave Roussy /ID# 276712

    Villejuif, Île-de-France Region, 94800

    Recruiting

Other trials in France

Spain13 sites, 13 recruiting

  • Complejo Hospitalario Universitario A Coruna /ID# 276416

    A Coruña, 15006

    Recruiting

  • Hospital Universitari Vall d Hebron /ID# 276478

    Barcelona, 08035

    Recruiting

  • Hospital Clinic de Barcelona /ID# 276412

    Barcelona, 08036

    Recruiting

  • Hospital Universitario Donostia /ID# 276404

    Donostia / San Sebastian, Guipuzcoa, 20014

    Recruiting

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

    Girona, 17007

    Recruiting

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

    Las Palmas de Gran Canaria, Las Palmas, 35016

    Recruiting

  • Clinica Universidad de Navarra - Madrid /ID# 276411

    Madrid, 28027

    Recruiting

  • Hospital Clinico San Carlos. /ID# 276407

    Madrid, 28040

    Recruiting

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

    Majadahonda, Madrid, 28222

    Recruiting

  • Hospital Universitario Marques de Valdecilla /ID# 276415

    Santander, Cantabria, 39008

    Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 276426

    Seville, Sevilla, 41013

    Recruiting

  • Instituto Valenciano de Oncologia /ID# 276413

    Valencia, 46009

    Recruiting

  • Hospital Clinico Universitario Lozano Blesa /ID# 276406

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Australia10 sites, 10 recruiting

  • Burnside War Memorial Hospital /ID# 277602

    Adelaide, South Australia, 5065

    Recruiting

  • Icon Cancer Centre Wesley /ID# 277199

    Auchenflower, Queensland, 4066

    Recruiting

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

    Clayton, Victoria, 3168

    Recruiting

  • Barwon Health /ID# 277297

    Geelong, Victoria, 3220

    Recruiting

  • Icon Cancer Centre Hobart /ID# 277688

    Hobart, Tasmania, 7000

    Recruiting

  • St. George Private Hospital /ID# 276570

    Kogarah, New South Wales, 2217

    Recruiting

  • Austin Hospital /ID# 276534

    Melbourne, Victoria, 3084

    Recruiting

  • Epworth HealthCare /ID# 276347

    Richmond, Victoria, 3121

    Recruiting

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

    Subiaco, Western Australia, 6008

    Recruiting

  • Chris O'Brien Lifehouse /ID# 276337

    Sydney, New South Wales, 2050

    Recruiting

Other trials in Australia

South Korea7 sites, 7 recruiting

  • National Cancer Center /ID# 276283

    Goyang-si, Gyeonggido, 10408

    Recruiting

  • Seoul National University Bundang Hospital /ID# 276280

    Seongnam-si, Gyeonggido, 13620

    Recruiting

  • Seoul National University Hospital /ID# 276182

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Yonsei University Health System - Severance Hospital /ID# 276266

    Seoul, Seoul Teugbyeolsi, 03722

    Recruiting

  • Asan Medical Center /ID# 276955

    Seoul, Seoul Teugbyeolsi, 05505

    Recruiting

  • Samsung Medical Center /ID# 276261

    Seoul, Seoul Teugbyeolsi, 06351

    Recruiting

  • Korea University Guro Hospital /ID# 276194

    Seoul, Seoul Teugbyeolsi, 08308

    Recruiting

Other trials in South Korea

Belgium5 sites, 5 recruiting

  • Cliniques Universitaires UCL Saint-Luc /ID# 276321

    Brussels, Brussels Capital, 1200

    Recruiting

  • AZ Maria Middelares /ID# 276325

    Ghent, Oost-Vlaanderen, 9000

    Recruiting

  • Universitair Ziekenhuis Leuven /ID# 276316

    Leuven, Vlaams-Brabant, 3000

    Recruiting

  • CHU de Liege /ID# 276500

    Liège, 4000

    Recruiting

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

    Namur, 5000

    Recruiting

Other trials in Belgium

Czechia4 sites, 4 recruiting

  • Masarykuv Onkologicky Ustav /ID# 276080

    Brno, Brno-mesto, 656 53

    Recruiting

  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 276205

    Hradec Králové, 500 05

    Recruiting

  • Vseobecna Fakultni nemocnice v Praze /ID# 276213

    Prague, Praha 17, 128 00

    Recruiting

  • Fakultni nemocnice Motol a Homolka /ID# 276300

    Prague, Praha 5, 150 06

    Recruiting

Other trials in Czechia

Denmark3 sites, 3 recruiting

  • Aalborg University Hospital /ID# 276435

    Aalborg, North Denmark, 9000

    Recruiting

  • Herlev Hospital /ID# 276831

    Herlev, Capital Region, 2730

    Recruiting

  • Odense University Hospital /ID# 276462

    Odense, Region Syddanmark, 5000

    Recruiting

Other trials in Denmark

About this study

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

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.

Read more

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.

Conditions
Ovarian Cancer
Being tested
Mirvetuximab Soravtansine, Bevacizumab, Carboplatin
Keywords
Ovarian Cancer, Mirvetuximab Soravtansine, Bevacizumab, Carboplatin
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07059845
Study groupRoleWhat they receive
Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose AExperimentalParticipants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration.
Receives: Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab
Substudy 1 Arm B: MIRV Dose BExperimentalParticipants will receive dose B of MIRV with Bev, as part of the approximately 40 month study duration.
Receives: Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab
Substudy 1 Arm C: BevExperimentalParticipants will receive Bev, as part of the approximately 40 month study duration.
Receives: Drug: Bevacizumab
Substudy 2 Arm D: MIRV Dose AExperimentalParticipants will receive dose A of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.
Receives: Drug: Mirvetuximab Soravtansine; Drug: Carboplatin
Substudy 2 Arm E: MIRV Dose BExperimentalParticipants will receive dose B of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.
Receives: Drug: Mirvetuximab Soravtansine; Drug: Carboplatin
Substudy 3 Arm F: MIRV Dose AExperimentalParticipants 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.
Receives: Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab; Drug: Carboplatin
Substudy 3 Arm G: MIRV Dose BExperimentalParticipants 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.
Receives: Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Approximately 40 Months

  2. 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.

    Measured: Up to Approximately 40 Months

  3. 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.

    Measured: Up to Approximately 40 Months

  4. 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.

    Measured: Up to Approximately 40 Months

  5. 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.

    Measured: Up to Approximately 40 Months

Secondary outcomes (5)

  1. Substudy 1, 2, and 3: CA-125 Response per Gynecologic Cancer Intergroup (GCIG) Criteria

    CA-125 response per GCIG Criteria.

    Measured: Up to Approximately 40 Months

  2. Substudy 1, 2, and 3: Duration of Response (DOR) as Assessed by the Investigator per RECIST v1.1

    DoR is defined for confirmed responders as the time from the participants' initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.

    Measured: Up to Approximately 40 Months

  3. Substudy 1, 2, and 3: Number of Participants with Peripheral Neuropathy 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.

    Measured: Up to Approximately 40 Months

  4. Substudy 1, 2, and 3: Number of Participants with Adjudicated Pneumonitis/ Interstitial Lung Disease (ILD) (any grade)

    ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication.

    Measured: Up to Approximately 40 Months

  5. Substudy 2 and 3: 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.

    Measured: Up to Approximately 40 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start13 Nov 2025
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07059845
Sponsor's protocol ID
M25-709
Other IDs
2025-521606-18, 2025
Acronym
FLORENZA
Status last verified
Oct 2026
First submitted
2 Jul 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirvetuximab Soravtansine, Bevacizumab and Carboplatin in people with Ovarian Cancer, run by AbbVie at 86 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, France, Spain, Australia, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Substudy 1, 2, and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3) (time frame: Up to Approximately 40 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07059845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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