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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
Sponsor: AbbVie
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2025-11-13
Completion Date
2029-01
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
Mirvetuximab Soravtansine
Intravenous (IV) infusion
Bevacizumab
IV Infusion
Carboplatin
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