RecruitingPhase 2NCT07059845

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

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


Sponsor

AbbVie

Enrollment

320 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing mirvetuximab soravtansine — an antibody-drug designed to target cancer cells that carry a specific protein called folate receptor alpha (FRα) — in combination with other treatments for women with ovarian, fallopian tube, or peritoneal cancer. The study includes two sub-studies: one for newly diagnosed patients and one for those with recurrent cancer. **You may be eligible if...** - You have been diagnosed with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer - Your tumor tests show medium or high levels of the folate receptor alpha (FRα) protein - For newly diagnosed (Substudy 1): your cancer is Stage III or IV - For recurrent disease (Substudy 2): your cancer has returned after prior treatment - You are in good overall health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - Your tumor tests negative or low for folate receptor alpha - You have had prior treatment with an FRα-targeted therapy - You have significant neuropathy (nerve damage) or eye problems - You are pregnant or breastfeeding - You have serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMirvetuximab Soravtansine

Intravenous (IV) infusion

DRUGBevacizumab

IV Infusion

DRUGCarboplatin

IV Infusion


Locations(10)

St. George Private Hospital /ID# 276570

Kogarah, New South Wales, Australia

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

Austin Hospital /ID# 276534

Melbourne, Victoria, Australia

Seoul National University Hospital /ID# 276182

Seoul, Seoul Teugbyeolsi, South Korea

Yonsei University Health System Severance Hospital /ID# 276266

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 276261

Seoul, Seoul Teugbyeolsi, South Korea

Korea University Guro Hospital /ID# 276194

Seoul, Seoul Teugbyeolsi, South Korea

View Full Details on ClinicalTrials.gov

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NCT07059845


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