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
NCT ID: NCT07059845
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
320 participants
INTERVENTIONAL
2025-10-07
2029-01-31
Brief Summary
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Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 2 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. Approximately 320 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 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Mirvetuximab Soravtansine
Intravenous (IV) infusion
Bevacizumab
IV Infusion
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.
Mirvetuximab Soravtansine
Intravenous (IV) infusion
Bevacizumab
IV Infusion
Substudy 1 Arm C: Bev
Participants will receive Bev, as part of the approximately 40 month study duration.
Bevacizumab
IV Infusion
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.
Mirvetuximab Soravtansine
Intravenous (IV) infusion
Carboplatin
IV Infusion
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.
Mirvetuximab Soravtansine
Intravenous (IV) infusion
Carboplatin
IV Infusion
Interventions
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Mirvetuximab Soravtansine
Intravenous (IV) infusion
Bevacizumab
IV Infusion
Carboplatin
IV Infusion
Eligibility Criteria
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Inclusion Criteria
* Substudy 1 and 2: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
* Substudy 1: Participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
* Substudy 1: Tumor must be confirmed HRD test negative (HRP), determined by a local homologous recombination deficient (HRD) test.
* Substudy 2: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
* Substudy 2: Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
* Substudy 2: Participants must have platinum-sensitive disease defined as radiographic progression greater than 6 months from the last dose of platinum-based chemotherapy.
* Substudy 2: 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 who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.
* Substudy 1: Participants who received prior treatment with mirvetuximab soravtansine, any FRα-targeting agent, or any investigational agent.
* 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, PARP inhibitor) 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 proceeding 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)
* Substudy 2: Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Icon Cancer Centre Wesley /ID# 277199
Auchenflower, Queensland, Australia
Burnside War Memorial Hospital /ID# 277602
Adelaide, South Australia, Australia
Icon Cancer Centre Hobart /ID# 277688
Hobart, Tasmania, Australia
Monash Health - Monash Medical Centre /ID# 276984
Clayton, Victoria, Australia
Seoul National University Hospital /ID# 276182
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 276261
Seoul, Seoul Teugbyeolsi, South Korea
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2025-521606-18
Identifier Type: OTHER
Identifier Source: secondary_id
M25-709
Identifier Type: -
Identifier Source: org_study_id