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

Recruiting now · Phase 2

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT07059845

Run by

AbbVie

People needed

400

Starts

2025-11-13

Expected to finish

2029-01-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.
• 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.

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).
• 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.

Where it is running

• UC San Diego Health - Moores Cancer Center /ID# 277574 — La Jolla, California, United States (enrolling)
• University of Florida College of Medicine /ID# 278348 — Gainesville, Florida, United States (enrolling)
• Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623 — Orlando, Florida, United States (enrolling)
• Florida Cancer Specialists - North /ID# 278626 — St. Petersburg, Florida, United States (enrolling)
• Florida Cancer Specialists - East /ID# 278605 — West Palm Beach, Florida, United States (enrolling)
• Baptist Health Lexington /ID# 278267 — Lexington, Kentucky, United States (enrolling)
• Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440 — Baton Rouge, Louisiana, United States (enrolling)
• Maine Medical Center - Scarborough Campus /ID# 277205 — Scarborough, Maine, United States (enrolling)
• Karmanos Cancer Institute - Detroit /ID# 277085 — Detroit, Michigan, United States (enrolling)
• Intermountain Health - Intermountain Health West End Clinic /ID# 278470 — Billings, Montana, United States (enrolling)
• Md Anderson Cancer Center At Cooper /ID# 278390 — Camden, New Jersey, United States (enrolling)
• SUNY Upstate Medical University - Syracuse /ID# 277245 — Syracuse, New York, United States (enrolling)
• FirstHealth of the Carolinas- Speciality Center /ID# 278636 — Pinehurst, North Carolina, United States (enrolling)
• Jamescare Gynecologic Oncology At Mill Run /ID# 277951 — Hilliard, Ohio, United States (enrolling)
• Willamette Valley Cancer Institute and Research Center /ID# 277714 — Eugene, Oregon, United States (enrolling)
• Penn Medicine University of Pennsylvania Health System /ID# 277963 — Philadelphia, Pennsylvania, United States (enrolling)
• Western Pennsylvania Gynecologic Oncology /ID# 278632 — Pittsburgh, Pennsylvania, United States (enrolling)
• Avera Cancer Institute - Sioux Falls /ID# 278627 — Sioux Falls, South Dakota, United States (enrolling)
• University Of Tennessee Medical Center /ID# 278225 — Knoxville, Tennessee, United States (enrolling)
• Texas Oncology - Abilene - Antilley Road /ID# 277739 — Abilene, Texas, United States (enrolling)
• Texas Oncology - Fort Worth Cancer Center /ID# 277989 — Fort Worth, Texas, United States (enrolling)
• Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735 — San Antonio, Texas, United States (enrolling)
• Texas Oncology - The Woodlands /ID# 277926 — The Woodlands, Texas, United States (enrolling)
• Texas Oncology - Northeast Texas /ID# 277737 — Tyler, Texas, United States (enrolling)
• Virginia Mason Hospital and Medical Center /ID# 277259 — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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