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NCT06682988PHASE2Recruiting

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

AbbVie

Start Date

5/28/2025

Completion Date

4/1/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: Both Cohorts * Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer. * Participants with platinum-resistant disease: * Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between \> 3 months and ≤ 6 months after the date of the last dose of platinum. * Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum. * Participants with progression diagnosed radiographically on or after their most recent line of therapy. * Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. * Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator). * Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity). Exclusion Criteria: Both Cohorts * Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor. * Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy. * Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol * Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.

Interventions

DRUG

Mirvetuximab Soravtansine

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Conditions

Advanced High-Grade Epithelial Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancers

Locations

First Physicians Group /ID# 272180

Sarasota, Florida 34239

United States

St. Elizabeth Medical Center - Edgewood /ID# 272113

Edgewood, Kentucky 41017

United States

Baptist Health Lexington /ID# 272211

Lexington, Kentucky 40503

United States

UMass Memorial Medical Center - Belmont Street /ID# 272122

Worcester, Massachusetts 01605

United States

Karmanos Cancer Institute - Detroit /ID# 272112

Detroit, Michigan 48201

United States

Allegheny Health Network West Penn Hospital /ID# 272267

Pittsburgh, Pennsylvania 15244

United States

Memorial Hermann Texas Medical Center /ID# 272227

Houston, Texas 77030

United States

Blacktown Hospital /ID# 272182

Blacktown, New South Wales 2148

Australia

Newcastle Private Hosptial /ID# 272213

Lambton Heights, New South Wales 2305

Australia

Royal Brisbane and Women's Hospital /ID# 272123

Brisbane, Queensland 4029

Australia

Icon Cancer Centre Chermside /ID# 272220

Chermside, Queensland 4032

Australia

Ballarat Base Hospital /ID# 272240

Ballarat, Victoria 3350

Australia

Monash Health - Monash Medical Centre - Clayton /ID# 272234

Clayton, Victoria 3168

Australia

Sir Charles Gairdner Hospital /ID# 272116

Nedlands, Western Australia 6009

Australia

Algemeen Ziekenhuis klina /ID# 272127

Brasschaat, Antwerpen 2930

Belgium

Cliniques Universitaires UCL Saint-Luc /ID# 272219

Brussels, Brussels Capital 1200

Belgium

AZ Maria Middelares /ID# 272186

Ghent, Oost-Vlaanderen 9000

Belgium

Universitair Ziekenhuis Leuven /ID# 277350

Leuven, Vlaams-Brabant 3000

Belgium

AZ-Delta /ID# 272250

Roeselare, West-Vlaanderen 8800

Belgium

Centre Francois Baclesse /ID# 272204

Caen, Calvados 14076

France

Centre Armoricain De Radiothérapie, D'Imagerie Médicale Et D'Oncologie (Cario) /ID# 272201

Plérin, Cotes-d Armor 22190

France

Institut De Cancérologie De Lorraine Alexis Vautrin /ID# 272147

Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54519

France

Centre Oscar Lambret /ID# 272183

Lille, Nord 59000

France

Centre Antoine-Lacassagne /ID# 272101

Nice, Provence-Alpes-Côte d'Azur Region 06189

France

HCL - Hopital Lyon Sud /ID# 272178

Pierre-Bénite, Rhone 69495

France

Centre Hospitalier Departemental Vendee (Chd Vendee) /ID# 272174

La Roche-sur-Yon, Vendee 85925

France

GH Diaconesses Croix Saint Simon-Hopital De La Croix Saint-Simon /ID# 272179

Paris, 75020

France

Mazowiecki Szpital Wojewodzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. /ID# 271692

Siedlce, Masovian Voivodeship 08-110

Poland

Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku /ID# 272169

Bialystok, Podlaskie Voivodeship 15-027

Poland

National Cancer Center /ID# 272265

Goyang-si, Gyeonggido 10408

South Korea

CHA Bundang Medical Center /ID# 271590

Seongnam, Gyeonggido 13496

South Korea

Seoul National University Bundang Hospital /ID# 271594

Seongnam-si, Gyeonggido 13620

South Korea

Keimyung University Dongsan Hospital /ID# 271592

Daegu, Gyeongsangbuk-do 42601

South Korea

Seoul National University Hospital /ID# 272264

Seoul, Seoul Teugbyeolsi 03080

South Korea

Yonsei University Health System Severance Hospital /ID# 271593

Seoul, Seoul Teugbyeolsi 03722

South Korea

Asan Medical Center /ID# 272130

Seoul, Seoul Teugbyeolsi 05505

South Korea

Gangnam Severance Hospital /ID# 272217

Seoul, Seoul Teugbyeolsi 06273

South Korea

Samsung Medical Center /ID# 271591

Seoul, Seoul Teugbyeolsi 06351

South Korea

Hospital Universitario Germans Trias i Pujol /ID# 272216

Badalona, Barcelona 08916

Spain

Hospital Universitario de Jaén /ID# 272205

Jaén, Jaen 23007

Spain

Hospital Clínico Universitario Virgen de la Arrixaca /ID# 272223

El Palmar, Murcia 30120

Spain

Clinica Universidad de Navarra - Pamplona /ID# 275742

Pamplona, Navarre 31008

Spain

Hospital Universitario Virgen del Rocio /ID# 272107

Seville, Sevilla 41013

Spain

Hospital Universitario Vall de Hebron /ID# 272134

Barcelona, 08035

Spain

Hospital General Universitario Gregorio Maranon /ID# 272121

Madrid, 28007

Spain

CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 272221

Madrid, 28027

Spain

Hospital Universitario HM Sanchinarro /ID# 272190

Madrid, 28050

Spain

Hospital Clinico Universitario de Valencia /ID# 272218

Valencia, 46010

Spain

Hospital Clinico Universitario Lozano Blesa /ID# 272165

Zaragoza, 50009

Spain

Addenbrookes Hospital /ID# 272162

Cambridge, Cambridgeshire CB2 2QQ

United Kingdom

Royal Devon and Exeter Hospital /ID# 272170

Exeter, Devon EX2 5DW

United Kingdom

University College London Hospital /ID# 272115

London, Greater London NW1 2BU

United Kingdom