Recruiting
Phase 2

Mirvetuximab Soravtansine & Bev

Sponsor:

AbbVie

Code:

NCT07059845

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mirvetuximab Soravtansine

Bevacizumab

Carboplatin

Study Details

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.

Conditions

Ovarian Cancer

Study ID

NCT07059845

Start date

Nov 13, 2025

Status verified date

Aug, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

experimental: Substudy 1 Arm C: Bev

Participants will receive Bev, as part of the approximately 40 month study duration.

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.

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.

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.

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.

Interventions

Mirvetuximab Soravtansine

Intravenous (IV) infusion

Bevacizumab

IV Infusion

Carboplatin

IV Infusion

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 ]
  • Substudy 1, 2, and 3: Number of Participants with TEAEs Leading to Discontinuation [ Time Frame: Up to Approximately 40 Months ]
  • Substudy 1, 2, and 3: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2) [ Time Frame: Up to Approximately 40 Months ]
  • Substudy 1, 2, and 3: Overall Response (OR) as Assessed by the Investigator per RECIST v1.1 [ Time Frame: Up to Approximately 40 Months ]
  • Substudy 1: Progression free survival (PFS) as Assessed by the Investigator per RECIST v1.1 [ Time Frame: Up to Approximately 40 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

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

Recruiting

La Jolla, California, United States, 92037

University of Florida College of Medicine /ID# 278348

Recruiting

Gainesville, Florida, United States, 32610

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

Recruiting

Orlando, Florida, United States, 32806

Florida Cancer Specialists - North /ID# 278626

Recruiting

St. Petersburg, Florida, United States, 33705

Florida Cancer Specialists - East /ID# 278605

Recruiting

West Palm Beach, Florida, United States, 33401

Baptist Health Lexington /ID# 278267

Recruiting

Lexington, Kentucky, United States, 40503

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

Recruiting

Baton Rouge, Louisiana, United States, 70817

Maine Medical Center - Scarborough Campus /ID# 277205

Recruiting

Scarborough, Maine, United States, 04074

UMass Memorial Medical Center - Belmont Street /ID# 278628

Recruiting

Worcester, Massachusetts, United States, 01605

Karmanos Cancer Institute - Detroit /ID# 277085

Recruiting

Detroit, Michigan, United States, 48201

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

Recruiting

Billings, Montana, United States, 59106

Md Anderson Cancer Center At Cooper /ID# 278390

Recruiting

Camden, New Jersey, United States, 08103

SUNY Upstate Medical University - Syracuse /ID# 277245

Recruiting

Syracuse, New York, United States, 13210

FirstHealth of the Carolinas- Speciality Center /ID# 278636

Recruiting

Pinehurst, North Carolina, United States, 28374

Jamescare Gynecologic Oncology At Mill Run /ID# 277951

Recruiting

Hilliard, Ohio, United States, 43026

Willamette Valley Cancer Institute and Research Center /ID# 277714

Recruiting

Eugene, Oregon, United States, 97401

Penn Medicine University of Pennsylvania Health System /ID# 277963

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Western Pennsylvania Gynecologic Oncology /ID# 278632

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Avera Cancer Institute - Sioux Falls /ID# 278627

Recruiting

Sioux Falls, South Dakota, United States, 57105

University Of Tennessee Medical Center /ID# 278225

Recruiting

Knoxville, Tennessee, United States, 37920

Texas Oncology - Abilene - Antilley Road /ID# 277739

Recruiting

Abilene, Texas, United States, 79606

Texas Oncology - Fort Worth Cancer Center /ID# 277989

Recruiting

Fort Worth, Texas, United States, 76104

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

Recruiting

San Antonio, Texas, United States, 78240

Texas Oncology - The Woodlands /ID# 277926

Recruiting

The Woodlands, Texas, United States, 77380

Texas Oncology - Northeast Texas /ID# 277737

Recruiting

Tyler, Texas, United States, 75702

Virginia Mason Hospital and Medical Center /ID# 277259

Recruiting

Seattle, Washington, United States, 98101

West Virginia University Hospitals /ID# 278965

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

AbbVie

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Ovarian Cancer
  • Mirvetuximab Soravtansine
  • Bevacizumab
  • Carboplatin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-21.