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RECRUITING
NCT07059845
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Mirvetuximab Soravtansine

Intravenous (IV) infusion

DRUG

Bevacizumab

IV Infusion

DRUG

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