A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine

RECRUITING

NCT06682988

PHASE2

Sponsor: AbbVie

Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide. The total study duration will be approximately 24 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 Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-05-28

Completion Date

2028-03

Last Updated

2026-01-09

Healthy Volunteers

No

Conditions

Advanced High-Grade Epithelial Ovarian Primary Peritoneal Fallopian Tube Cancers High Folate Receptor-Alpha Expression Platinum Resistant

Interventions

DRUG

Mirvetuximab Soravtansine

intravenous (IV) infusion

Locations (37)

First Physicians Group /ID# 272180

Sarasota, Florida, United States

St. Elizabeth Medical Center - Edgewood /ID# 272113

Edgewood, Kentucky, United States

Baptist Health Lexington /ID# 272211

Lexington, Kentucky, United States

UMass Memorial Medical Center /ID# 272122

Worcester, Massachusetts, United States

Karmanos Cancer Institute - Detroit /ID# 272112

Detroit, Michigan, United States

Allegheny Health Network West Penn Hospital /ID# 272267

Pittsburgh, Pennsylvania, United States

Blacktown Hospital /ID# 272182

Blacktown, New South Wales, Australia

Newcastle Private Hosptial /ID# 272213

Lambton Heights, New South Wales, Australia

Royal Brisbane and Women's Hospital /ID# 272123

Brisbane, Queensland, Australia

Icon Cancer Centre Chermside /ID# 272220

Chermside, Queensland, Australia

Ballarat Base Hospital /ID# 272240

Ballarat, Victoria, Australia

Monash Health - Monash Medical Centre /ID# 272234

Clayton, Victoria, Australia

Sir Charles Gairdner Hospital /ID# 272116

Nedlands, Western Australia, Australia

Algemeen Ziekenhuis klina /ID# 272127

Brasschaat, Antwerpen, Belgium

AZ Maria Middelares /ID# 272186

Ghent, Oost-Vlaanderen, Belgium

AZ-Delta /ID# 272250

Roeselare, West-Vlaanderen, Belgium

National Cancer Center /ID# 272265

Goyang-si, Gyeonggido, South Korea

CHA Bundang Medical Center /ID# 271590

Seongnam, Gyeonggido, South Korea

Seoul National University Bundang Hospital /ID# 271594

Seongnam-si, Gyeonggido, South Korea

Keimyung University Dongsan Hospital /ID# 271592

Daegu, Gyeongsangbuk-do, South Korea

Seoul National University Hospital /ID# 272264