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Study of Mirvetuximab Soravtansine Combinations for Ovarian Cancer

This study is for adults with ovarian cancer to see how safe and effective different combinations of treatments are. We are looking at mirvetuximab soravtansine, an investigational drug, when given with carboplatin, or bevacizumab (Bev), or Bev alone. To join, your tumor must show a specific biomarker called folate receptor alpha (FRa) positivity. The main goal is to track any side effects (adverse events) and how your disease activity changes over time, up to about 40 months. This study is currently recruiting 400 participants, but its overall status is unclear.

Study design
This interventional study plans to enroll 400 participants. You will be assigned to one of three substudies, and then to a specific treatment group.
What's involved
You will need to provide a tumor tissue sample or undergo a new biopsy to confirm FRα expression. You will receive intravenous (IV) infusions of the study drugs.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and disease activity for up to approximately 40 months.

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NCT07059845

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
PHASE2Ages 18+InterventionalTreatment
AbbVie
~400 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Mirvetuximab SoravtansineBevacizumabCarboplatin

At a glance

Recruiting sites
82 of 83 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Substudy 1, 2, and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3)
Measured over Up to Approximately 40 Months
+4 more outcomes measured

Conditions

Ovarian Cancer

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Where it's being run

83 sites across 57 states
Spain8
Texas5
Seoul Teugbyeolsi5
Florida4
Victoria4
California2
Pennsylvania2
New South Wales2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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.
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

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).
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.
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.

What this trial measures

  • Substudy 1, 2, and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3)Up to Approximately 40 Months

    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.

  • Substudy 1, 2, and 3: Number of Participants with TEAEs Leading to DiscontinuationUp to Approximately 40 Months

    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.

  • Substudy 1, 2, and 3: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2)Up to Approximately 40 Months

    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.

  • Substudy 1, 2, and 3: Overall Response (OR) as Assessed by the Investigator per RECIST v1.1Up to Approximately 40 Months

    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.

  • Substudy 1: Progression free survival (PFS) as Assessed by the Investigator per RECIST v1.1Up to Approximately 40 Months

    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.