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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 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.

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

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-11-13

Completion Date

2029-01

Last Updated

2026-07-13

Healthy Volunteers

Conditions

Ovarian Cancer

Interventions

DRUG

Mirvetuximab Soravtansine

Intravenous (IV) infusion

DRUG

Bevacizumab

IV Infusion

DRUG

Carboplatin

IV Infusion

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.

Locations (77)

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

La Jolla, California, United States

Sansum Clinic - Solvang /ID# 277712

Solvang, California, United States

University of Florida College of Medicine /ID# 278348

Gainesville, Florida, United States

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

Orlando, Florida, United States

Florida Cancer Specialists - North /ID# 278626

St. Petersburg, Florida, United States

Florida Cancer Specialists - East /ID# 278605

West Palm Beach, Florida, United States

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

Baton Rouge, Louisiana, United States

Maine Medical Center - Scarborough Campus /ID# 277205

Scarborough, Maine, United States

Karmanos Cancer Institute - Detroit /ID# 277085

Detroit, Michigan, United States

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

Billings, Montana, United States

Md Anderson Cancer Center At Cooper /ID# 278390

Camden, New Jersey, United States

SUNY Upstate Medical University - Syracuse /ID# 277245

Syracuse, New York, United States

FirstHealth of the Carolinas- Speciality Center /ID# 278636

Pinehurst, North Carolina, United States

Jamescare Gynecologic Oncology At Mill Run /ID# 277951

Hilliard, Ohio, United States

Willamette Valley Cancer Institute and Research Center /ID# 277714

Eugene, Oregon, United States

Penn Medicine University of Pennsylvania Health System /ID# 277963

Philadelphia, Pennsylvania, United States

Avera Cancer Institute - Sioux Falls /ID# 278627

Sioux Falls, South Dakota, United States

University Of Tennessee Medical Center /ID# 278225

Knoxville, Tennessee, United States

Texas Oncology - Abilene - Antilley Road /ID# 277739

Abilene, Texas, United States

Texas Oncology - Fort Worth Cancer Center /ID# 277989

Fort Worth, Texas, United States

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

San Antonio, Texas, United States

Texas Oncology - The Woodlands /ID# 277926

The Woodlands, Texas, United States

Texas Oncology - Northeast Texas /ID# 277737

Tyler, Texas, United States

Virginia Mason Hospital and Medical Center /ID# 277259

Seattle, Washington, United States

West Virginia University Hospitals /ID# 278965

Morgantown, West Virginia, United States

St. George Private Hospital /ID# 276570

Kogarah, New South Wales, Australia

Chris O'Brien Lifehouse /ID# 276337

Sydney, 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 - Clayton /ID# 276984

Clayton, Victoria, Australia

Barwon Health /ID# 277297

Geelong, Victoria, Australia

Austin Hospital /ID# 276534

Melbourne, Victoria, Australia

Epworth Hospital - Richmond /ID# 276347

Richmond, Victoria, Australia

St. John Of God Subiaco Hospital /ID# 277174

Subiaco, Western Australia, Australia

Cliniques Universitaires UCL Saint-Luc /ID# 276321

Brussels, Brussels Capital, Belgium

AZ Maria Middelares /ID# 276325

Ghent, Oost-Vlaanderen, Belgium

Universitair Ziekenhuis Leuven /ID# 276316

Leuven, Vlaams-Brabant, Belgium

CHU de Liege /ID# 276500

Liège, Belgium

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

Namur, Belgium

Vseobecna Fakultni nemocnice v Praze /ID# 276213

Prague, Praha 17, Czechia

Fakultni nemocnice Motol a Homolka /ID# 276300

Prague, Praha 5, Czechia

Herlev Hospital /ID# 276831

Herlev, Capital Region, Denmark

Aalborg University Hospital /ID# 276435

Aalborg, North Denmark, Denmark

Odense University Hospital /ID# 276462

Odense, Region Syddanmark, Denmark

Strasbourg Oncologie Liberale /ID# 276698

Strasbourg, Bas-Rhin, France

Centre Georges François Leclerc /ID# 276737

Dijon, Bourgogne-Franche-Comté, France

Centre Francois Baclesse /ID# 276709

Caen, Calvados, France

Hopital Prive Des Cotes D'Armor /ID# 276706

Plérin, Cotes-d Armor, France

Institut Bergonie /ID# 276696

Bordeaux, Gironde, France

Institut Curie -Site Saint-Cloud /ID# 276850

Saint-Cloud, Hauts-de-Seine, France

Institut Godinot /ID# 276849

Reims, Marne, France

CHU de Limoges site CHU Dupuytren 1 /ID# 276851

Limoges, New Aquitaine, France

IUCT Oncopole /ID# 276705

Toulouse, Occitanie, France

Centre Antoine-Lacassagne /ID# 276708

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

Centre Leon Berard /ID# 276710

Lyon, Rhone, France

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

Avignon, Vaucluse, France

Institut Gustave Roussy /ID# 276712

Villejuif, Île-de-France Region, France

National Cancer Center /ID# 276283

Goyang-si, Gyeonggido, South Korea

Seoul National University Bundang Hospital /ID# 276280

Seongnam-si, Gyeonggido, South Korea

Seoul National University Hospital /ID# 276182