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NCT07059845PHASE2Recruiting

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

AbbVie

Start Date

11/13/2025

Completion Date

1/1/2029

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 3 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. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 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 carboplatin and 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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: Substudy 1 * Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity. * Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. * 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. 2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. * Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available. Substudy 2 * Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity. * Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. * Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. * Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy. * Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy. * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline. Substudy 3 * Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \>= 50% of viable tumor cells with \>= 2+ staining intensity. * Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. * Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. * Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy. * Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy. * Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline. Exclusion Criteria: Substudy 1 * Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization. * Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization. * Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi). Substudy 2 * More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations: * Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens. * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently). * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen) * Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents. Substudy 3 * More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations: * Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens. * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently). * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen) * Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.

Interventions

DRUG

Mirvetuximab Soravtansine

DRUG

Bevacizumab

DRUG

Carboplatin

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Conditions

Ovarian Cancer

Locations

UC San Diego Health - Moores Cancer Center /ID# 277574

La Jolla, California 92037

United States

Sansum Clinic - Solvang /ID# 277712

Solvang, California 93463

United States

University of Florida College of Medicine /ID# 278348

Gainesville, Florida 32610

United States

Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623

Orlando, Florida 32806

United States

Florida Cancer Specialists - North /ID# 278626

St. Petersburg, Florida 33705

United States

Florida Cancer Specialists - East /ID# 278605

West Palm Beach, Florida 33401

United States

Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440

Baton Rouge, Louisiana 70817

United States

Maine Medical Center - Scarborough Campus /ID# 277205

Scarborough, Maine 04074

United States

Karmanos Cancer Institute - Detroit /ID# 277085

Detroit, Michigan 48201

United States

Intermountain Health - Intermountain Health West End Clinic /ID# 278470

Billings, Montana 59106

United States

Md Anderson Cancer Center At Cooper /ID# 278390

Camden, New Jersey 08103

United States

SUNY Upstate Medical University - Syracuse /ID# 277245

Syracuse, New York 13210

United States

FirstHealth of the Carolinas- Speciality Center /ID# 278636

Pinehurst, North Carolina 28374

United States

Jamescare Gynecologic Oncology At Mill Run /ID# 277951

Hilliard, Ohio 43026

United States

Willamette Valley Cancer Institute and Research Center /ID# 277714

Eugene, Oregon 97401

United States

Penn Medicine University of Pennsylvania Health System /ID# 277963

Philadelphia, Pennsylvania 19104

United States

Western Pennsylvania Gynecologic Oncology /ID# 278632

Pittsburgh, Pennsylvania 15224

United States

Avera Cancer Institute - Sioux Falls /ID# 278627

Sioux Falls, South Dakota 57105

United States

University Of Tennessee Medical Center /ID# 278225

Knoxville, Tennessee 37920

United States

Texas Oncology - Abilene - Antilley Road /ID# 277739

Abilene, Texas 79606

United States

Texas Oncology - Fort Worth Cancer Center /ID# 277989

Fort Worth, Texas 76104

United States

Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735

San Antonio, Texas 78240

United States

Texas Oncology - The Woodlands /ID# 277926

The Woodlands, Texas 77380

United States

Texas Oncology - Northeast Texas /ID# 277737

Tyler, Texas 75702

United States

Virginia Mason Hospital and Medical Center /ID# 277259

Seattle, Washington 98101

United States

West Virginia University Hospitals /ID# 278965

Morgantown, West Virginia 26506

United States

St. George Private Hospital /ID# 276570

Kogarah, New South Wales 2217

Australia

Chris O'Brien Lifehouse /ID# 276337

Sydney, New South Wales 2050

Australia

Icon Cancer Centre Wesley /ID# 277199

Auchenflower, Queensland 4066

Australia

Burnside War Memorial Hospital /ID# 277602

Adelaide, South Australia 5065

Australia

Icon Cancer Centre Hobart /ID# 277688

Hobart, Tasmania 7000

Australia

Monash Health - Monash Medical Centre - Clayton /ID# 276984

Clayton, Victoria 3168

Australia

Barwon Health /ID# 277297

Geelong, Victoria 3220

Australia

Austin Hospital /ID# 276534

Melbourne, Victoria 3084

Australia

Epworth Hospital - Richmond /ID# 276347

Richmond, Victoria 3121

Australia

St. John Of God Subiaco Hospital /ID# 277174

Subiaco, Western Australia 6008

Australia

Cliniques Universitaires UCL Saint-Luc /ID# 276321

Brussels, Brussels Capital 1200

Belgium

AZ Maria Middelares /ID# 276325

Ghent, Oost-Vlaanderen 9000

Belgium

Universitair Ziekenhuis Leuven /ID# 276316

Leuven, Vlaams-Brabant 3000

Belgium

CHU de Liege /ID# 276500

Liège, 4000

Belgium

UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 277183

Namur, 5000

Belgium

Masarykuv Onkologicky Ustav /ID# 276080

Brno, Brno-mesto 656 53

Czechia

Vseobecna Fakultni nemocnice v Praze /ID# 276213

Prague, Praha 17 128 00

Czechia

Fakultni nemocnice Motol a Homolka /ID# 276300

Prague, Praha 5 150 06

Czechia

Fakultni nemocnice Hradec Kralove - Sokolska /ID# 276205

Hradec Králové, 500 05

Czechia

Herlev Hospital /ID# 276831

Herlev, Capital Region 2730

Denmark

Aalborg University Hospital /ID# 276435

Aalborg, North Denmark 9000

Denmark

Odense University Hospital /ID# 276462

Odense, Region Syddanmark 5000

Denmark

Strasbourg Oncologie Liberale /ID# 276698

Strasbourg, Bas-Rhin 67000

France

Centre Georges Francois Leclerc /ID# 276737

Dijon, Bourgogne-Franche-Comté 21079

France

Centre Francois Baclesse /ID# 276709

Caen, Calvados 14076

France

Hopital Prive Des Cotes D'Armor /ID# 276706

Plérin, Cotes-d Armor 22190

France

Institut Bergonie /ID# 276696

Bordeaux, Gironde 33076

France

Institut Curie -Site Saint-Cloud /ID# 276850

Saint-Cloud, Hauts-de-Seine 92210

France

Institut Godinot /ID# 276849

Reims, Marne 51726

France

CHU de Limoges site CHU Dupuytren 1 /ID# 276851

Limoges, New Aquitaine 87000

France

IUCT Oncopole /ID# 276705

Toulouse, Occitanie 31059

France

Centre Antoine-Lacassagne /ID# 276708

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

France

Centre Leon Berard /ID# 276710

Lyon, Rhone 69373

France

Institut du Cancer Avignon Provence - Sainte Catherine /ID# 276692

Avignon, Vaucluse 84918

France

Institut Gustave Roussy /ID# 276712

Villejuif, Île-de-France Region 94800

France

National Cancer Center /ID# 276283

Goyang-si, Gyeonggido 10408

South Korea

Seoul National University Bundang Hospital /ID# 276280

Seongnam-si, Gyeonggido 13620

South Korea

Seoul National University Hospital /ID# 276182

Seoul, Seoul Teugbyeolsi 03080

South Korea

Yonsei University Health System Severance Hospital /ID# 276266

Seoul, Seoul Teugbyeolsi 03722

South Korea

Asan Medical Center /ID# 276955

Seoul, Seoul Teugbyeolsi 05505

South Korea

Samsung Medical Center /ID# 276261

Seoul, Seoul Teugbyeolsi 06351

South Korea

Korea University Guro Hospital /ID# 276194

Seoul, Seoul Teugbyeolsi 08308

South Korea

Hospital Universitario Marques de Valdecilla /ID# 276415

Santander, Cantabria 39008

Spain

Hospital Universitario Donostia /ID# 276404

Donostia / San Sebastian, Guipuzcoa 20014

Spain

Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 276438

Las Palmas de Gran Canaria, Las Palmas 35016

Spain

Hospital Universitario Virgen del Rocio /ID# 276426

Seville, Sevilla 41013

Spain

Complejo Hospitalario Universitario A Coruna /ID# 276416

A Coruña, 15006

Spain

Hospital Universitari Vall d Hebron /ID# 276478

Barcelona, 08035

Spain

Hospital Clinic de Barcelona /ID# 276412

Barcelona, 08036

Spain

Institut Catala D Oncologia - Ico - Girona /ID# 276410

Girona, 17007

Spain

Clinica Universidad de Navarra - Madrid /ID# 276411

Madrid, 28027

Spain

Hospital Clinico San Carlos. /ID# 276407

Madrid, 28040

Spain

Instituto Valenciano de Oncologia /ID# 276413

Valencia, 46009

Spain

Hospital Clinico Universitario Lozano Blesa /ID# 276406

Zaragoza, 50009

Spain