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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: Bevacizumab; Drug: Mirvetuximab Soravtansine

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Recruiting
      • St. George Private Hospital /ID# 276570
    • Sydney, New South Wales, Australia, 2050
      • Recruiting
      • Chris O'Brien Lifehouse /ID# 276337
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Recruiting
      • Icon Cancer Centre Wesley /ID# 277199
  • South Australia
    • Adelaide, South Australia, Australia, 5065
      • Recruiting
      • Burnside War Memorial Hospital /ID# 277602
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Recruiting
      • Icon Cancer Centre Hobart /ID# 277688
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Health - Monash Medical Centre - Clayton /ID# 276984
    • Geelong, Victoria, Australia, 3220
      • Recruiting
      • Barwon Health /ID# 277297
    • Melbourne, Victoria, Australia, 3084
      • Recruiting
      • Austin Hospital /ID# 276534
    • Richmond, Victoria, Australia, 3121
      • Recruiting
      • Epworth Hospital - Richmond /ID# 276347
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • Recruiting
      • St. John Of God Subiaco Hospital /ID# 277174
• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • CHU de Liege /ID# 276500
  • Namur, Belgium, 5000
    • Recruiting
    • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 277183
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1200
      • Recruiting
      • Cliniques Universitaires UCL Saint-Luc /ID# 276321
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • AZ Maria Middelares /ID# 276325
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • Universitair Ziekenhuis Leuven /ID# 276316
• Denmark
  • Capital Region
    • Herlev, Capital Region, Denmark, 2730
      • Recruiting
      • Herlev Hospital /ID# 276831
  • North Denmark
    • Aalborg, North Denmark, Denmark, 9000
      • Recruiting
      • Aalborg University Hospital /ID# 276435
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Recruiting
      • Odense University Hospital /ID# 276462
• France
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67000
      • Recruiting
      • Strasbourg Oncologie Liberale /ID# 276698
  • Bourgogne-Franche-Comté
    • Dijon, Bourgogne-Franche-Comté, France, 21079
      • Recruiting
      • Centre Georges François Leclerc /ID# 276737
  • Calvados
    • Caen, Calvados, France, 14076
      • Recruiting
      • Centre Francois Baclesse /ID# 276709
  • Cotes-d Armor
    • Plérin, Cotes-d Armor, France, 22190
      • Recruiting
      • Hopital Prive Des Cotes D'Armor /ID# 276706
  • Gironde
    • Bordeaux, Gironde, France, 33076
      • Recruiting
      • Institut Bergonie /ID# 276696
  • Hauts-de-Seine
    • Saint-Cloud, Hauts-de-Seine, France, 92210
      • Recruiting
      • Institut Curie -Site Saint-Cloud /ID# 276850
  • Marne
    • Reims, Marne, France, 51726
      • Recruiting
      • Institut Godinot /ID# 276849
  • New Aquitaine
    • Limoges, New Aquitaine, France, 87000
      • Recruiting
      • CHU de Limoges site CHU Dupuytren 1 /ID# 276851
  • Occitanie
    • Toulouse, Occitanie, France, 31059
      • Recruiting
      • IUCT Oncopole /ID# 276705
  • Provence-Alpes-Côte d'Azur Region
    • Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
      • Recruiting
      • Centre Antoine-Lacassagne /ID# 276708
  • Rhone
    • Lyon, Rhone, France, 69373
      • Recruiting
      • Centre Leon Berard /ID# 276710
  • Vaucluse
    • Avignon, Vaucluse, France, 84918
      • Recruiting
      • Institut du Cancer Avignon Provence - Sainte Catherine /ID# 276692
  • Île-de-France Region
    • Villejuif, Île-de-France Region, France, 94800
      • Recruiting
      • Institut Gustave Roussy /ID# 276712
• South Korea
  • Gyeonggido
    • Goyang-si, Gyeonggido, South Korea, 10408
      • Recruiting
      • National Cancer Center /ID# 276283
    • Seongnam-si, Gyeonggido, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital /ID# 276280
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center /ID# 276261
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital /ID# 276182
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Yonsei University Health System Severance Hospital /ID# 276266
    • Seoul, Seoul Teugbyeolsi, South Korea, 08308
      • Recruiting
      • Korea University Guro Hospital /ID# 276194
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • Recruiting
      • Asan Medical Center /ID# 276955
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron /ID# 276478
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona /ID# 276412
  • Girona, Spain, 17007
    • Recruiting
    • Institut Català D'Oncologia (Ico) - Girona /ID# 276410
  • Madrid, Spain, 28027
    • Recruiting
    • Clinica Universidad de Navarra - Madrid /ID# 276411
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos. /ID# 276407
  • Valencia, Spain, 46009
    • Recruiting
    • Instituto Valenciano de Oncología /ID# 276413
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Clinico Universitario Lozano Blesa /ID# 276406
  • A Coruna
    • A Coruña, A Coruna, Spain, 15006
      • Recruiting
      • Complejo Hospitalario Universitario A Coruña /ID# 276416
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla /ID# 276415
  • Guipuzcoa
    • Donostia / San Sebastian, Guipuzcoa, Spain, 20014
      • Recruiting
      • Hospital Universitario Donostia /ID# 276404
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
      • Recruiting
      • Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 276438
  • Sevilla
    • Seville, Sevilla, Spain, 41013
      • Recruiting
      • Hospital Universitario Virgen del Rocio /ID# 276426
• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • UC San Diego Health - Moores Cancer Center /ID# 277574
    • Solvang, California, United States, 93463
      • Active, not recruiting
      • Sansum Clinic - Solvang /ID# 277712
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida College of Medicine /ID# 278348
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623
    • St. Petersburg, Florida, United States, 33705
      • Recruiting
      • Florida Cancer Specialists - North /ID# 278626
    • West Palm Beach, Florida, United States, 33401
      • Recruiting
      • Florida Cancer Specialists - East /ID# 278605
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
      • Recruiting
      • Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440
  • Maine
    • Scarborough, Maine, United States, 04074
      • Recruiting
      • Maine Medical Center - Scarborough Campus /ID# 277205
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute - Detroit /ID# 277085
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Recruiting
      • FirstHealth of the Carolinas- Speciality Center /ID# 278636
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Willamette Valley Cancer Institute and Research Center /ID# 277714
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Medicine: University of Pennsylvania Health System /ID# 277963
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Avera Cancer Institute - Sioux Falls /ID# 278627
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University Of Tennessee Medical Center /ID# 278225
  • Texas
    • Abilene, Texas, United States, 79606
      • Recruiting
      • Texas Oncology - Abilene - Antilley Road /ID# 277739
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Texas Oncology - Fort Worth Cancer Center /ID# 277989
    • San Antonio, Texas, United States, 78240
      • Recruiting
      • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735
    • The Woodlands, Texas, United States, 77380
      • Recruiting
      • Texas Oncology - The Woodlands /ID# 277926
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology - Northeast Texas /ID# 277737
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Virginia Mason Hospital & Medical Center /ID# 277259
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University Hospitals /ID# 278965

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A; Participants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration.	Drug: Bevacizumab; IV Infusion; Drug: Mirvetuximab Soravtansine; Intravenous (IV) infusion
Experimental: Substudy 1 Arm B: MIRV Dose B; Participants will receive dose B of MIRV with Bev, as part of the approximately 40 month study duration.	Drug: Bevacizumab; IV Infusion; Drug: Mirvetuximab Soravtansine; Intravenous (IV) infusion
Experimental: Substudy 1 Arm C: Bev; Participants will receive Bev, as part of the approximately 40 month study duration.	Drug: Bevacizumab; IV Infusion
Experimental: Substudy 2 Arm D: MIRV Dose A; Participants will receive dose A of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.	Drug: Carboplatin; IV Infusion; Drug: Mirvetuximab Soravtansine; Intravenous (IV) infusion
Experimental: Substudy 2 Arm E: MIRV Dose B; Participants will receive dose B of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.	Drug: Carboplatin; IV Infusion; Drug: Mirvetuximab Soravtansine; Intravenous (IV) infusion
Experimental: Substudy 3 Arm F: MIRV Dose A; Participants 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.	Drug: Carboplatin; IV Infusion; Drug: Bevacizumab; IV Infusion; Drug: Mirvetuximab Soravtansine; Intravenous (IV) infusion
Experimental: Substudy 3 Arm G: MIRV Dose B; Participants 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.	Drug: Carboplatin; IV Infusion; Drug: Bevacizumab; IV Infusion; Drug: Mirvetuximab Soravtansine; Intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substudy 1, 2, and 3: CA-125 Response per Gynecologic Cancer Intergroup (GCIG) Criteria	CA-125 response per 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	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.	Up to Approximately 40 Months
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.	Up to Approximately 40 Months
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.	Up to Approximately 40 Months
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.	Up to Approximately 40 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: July 2, 2025
• First Submitted That Met QC Criteria: July 2, 2025
• First Posted (Actual): July 11, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Bevacizumab; Carboplatin; Ovarian Cancer; Mirvetuximab Soravtansine
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Bevacizumab; Carboplatin; mirvetuximab soravtansine
• Other Study ID Numbers: M25-709; 2025-521606-18 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes