N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 2 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07059845

Registry updated: 2026-10-13
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Mirvetuximab Soravtansine (Drug)
    Intravenous (IV) infusion
  • Bevacizumab (Drug)
    IV Infusion
  • Carboplatin (Drug)
    IV Infusion

Eligibility criteria

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.

Conditions

Ovarian Cancer

Locations

  • 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
  • Baptist Health Lexington /ID# 278267 — Lexington, Kentucky, 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
  • UMass Memorial Medical Center - Belmont Street /ID# 278628 — Worcester, Massachusetts, 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
  • Columbia University Medical Center /ID# 277990 — New York, New York, 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
  • Western Pennsylvania Gynecologic Oncology /ID# 278632 — Pittsburgh, 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
  • University of Texas - Southwestern Medical Center /ID# 278289 — Dallas, 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 Commonwealth University Medical Center /ID# 277932 — Richmond, Virginia, 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 HealthCare /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
  • Masarykuv Onkologicky Ustav /ID# 276080 — Brno, Brno-mesto, Czechia
  • Vseobecna Fakultni nemocnice v Praze /ID# 276213 — Prague, Praha 17, Czechia
  • Fakultni nemocnice Motol a Homolka /ID# 276300 — Prague, Praha 5, Czechia
  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 276205 — Hradec Králové, 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 Francois Leclerc /ID# 276737 — Dijon, Bourgogne-Franche-Comté, France
  • Centre Francois Baclesse /ID# 276709 — Caen, Calvados, France
  • Centre Armoricain De Radiotherapie D Imagerie Medicale Et D Oncologie - Cario /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 — Seoul, Seoul Teugbyeolsi, South Korea
  • Yonsei University Health System - Severance Hospital /ID# 276266 — Seoul, Seoul Teugbyeolsi, South Korea
  • Asan Medical Center /ID# 276955 — 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
  • Hospital Universitario Marques de Valdecilla /ID# 276415 — Santander, Cantabria, Spain
  • Hospital Universitario Donostia /ID# 276404 — Donostia / San Sebastian, Guipuzcoa, Spain
  • Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 276438 — Las Palmas de Gran Canaria, Las Palmas, Spain
  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 281304 — Majadahonda, Madrid, Spain
  • Hospital Universitario Virgen del Rocio /ID# 276426 — Seville, Sevilla, Spain
  • Complejo Hospitalario Universitario A Coruna /ID# 276416 — A Coruña, Spain
  • Hospital Universitari Vall d Hebron /ID# 276478 — Barcelona, Spain
  • Hospital Clinic de Barcelona /ID# 276412 — Barcelona, Spain
  • Institut Catala D Oncologia - Ico - Girona /ID# 276410 — Girona, Spain
  • Clinica Universidad de Navarra - Madrid /ID# 276411 — Madrid, Spain
  • Hospital Clinico San Carlos. /ID# 276407 — Madrid, Spain
  • Instituto Valenciano de Oncologia /ID# 276413 — Valencia, Spain
  • Hospital Clinico Universitario Lozano Blesa /ID# 276406 — Zaragoza, Spain
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record