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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

NCT07059845 · AbbVie
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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
About this study
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
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.
Study design
Enrollment target: 400 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-13
Estimated completion: 2029-01
Last updated: 2026-06-04
Interventions
Drug: Mirvetuximab SoravtansineDrug: BevacizumabDrug: Carboplatin
Primary outcomes
  • Substudy 1, 2, and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3) (Up to Approximately 40 Months)
  • Substudy 1, 2, and 3: Number of Participants with TEAEs Leading to Discontinuation (Up to Approximately 40 Months)
  • Substudy 1, 2, and 3: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2) (Up to Approximately 40 Months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (71)
UC San Diego Health - Moores Cancer Center /ID# 277574Recruiting
La Jolla, California, United States
Sansum Clinic - Solvang /ID# 277712Active Not Recruiting
Solvang, California, United States
University of Florida College of Medicine /ID# 278348Recruiting
Gainesville, Florida, United States
Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623Recruiting
Orlando, Florida, United States
Florida Cancer Specialists - North /ID# 278626Recruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists - East /ID# 278605Recruiting
West Palm Beach, Florida, United States
Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440Recruiting
Baton Rouge, Louisiana, United States
Maine Medical Center - Scarborough Campus /ID# 277205Recruiting
Scarborough, Maine, United States
Karmanos Cancer Institute - Detroit /ID# 277085Recruiting
Detroit, Michigan, United States
FirstHealth of the Carolinas- Speciality Center /ID# 278636Recruiting
Pinehurst, North Carolina, United States
Willamette Valley Cancer Institute and Research Center /ID# 277714Recruiting
Eugene, Oregon, United States
Penn Medicine: University of Pennsylvania Health System /ID# 277963Recruiting
Philadelphia, Pennsylvania, United States
Avera Cancer Institute - Sioux Falls /ID# 278627Recruiting
Sioux Falls, South Dakota, United States
University Of Tennessee Medical Center /ID# 278225Recruiting
Knoxville, Tennessee, United States
Texas Oncology - Abilene - Antilley Road /ID# 277739Recruiting
Abilene, Texas, United States
Texas Oncology - Fort Worth Cancer Center /ID# 277989Recruiting
Fort Worth, Texas, United States
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735Recruiting
San Antonio, Texas, United States
Texas Oncology - The Woodlands /ID# 277926Recruiting
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas /ID# 277737Recruiting
Tyler, Texas, United States
Virginia Mason Hospital & Medical Center /ID# 277259Recruiting
Seattle, Washington, United States
West Virginia University Hospitals /ID# 278965Recruiting
Morgantown, West Virginia, United States
St. George Private Hospital /ID# 276570Recruiting
Kogarah, New South Wales, Australia
Chris O'Brien Lifehouse /ID# 276337Recruiting
Sydney, New South Wales, Australia
Icon Cancer Centre Wesley /ID# 277199Recruiting
Auchenflower, Queensland, Australia
Burnside War Memorial Hospital /ID# 277602Recruiting
Adelaide, South Australia, Australia
Icon Cancer Centre Hobart /ID# 277688Recruiting
Hobart, Tasmania, Australia
Monash Health - Monash Medical Centre - Clayton /ID# 276984Recruiting
Clayton, Victoria, Australia
Barwon Health /ID# 277297Recruiting
Geelong, Victoria, Australia
Austin Hospital /ID# 276534Recruiting
Melbourne, Victoria, Australia
Epworth Hospital - Richmond /ID# 276347Recruiting
Richmond, Victoria, Australia
St. John Of God Subiaco Hospital /ID# 277174Recruiting
Subiaco, Western Australia, Australia
Cliniques Universitaires UCL Saint-Luc /ID# 276321Recruiting
Brussels, Brussels Capital, Belgium
AZ Maria Middelares /ID# 276325Recruiting
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 276316Recruiting
Leuven, Vlaams-Brabant, Belgium
CHU de Liege /ID# 276500Recruiting
Liège, Belgium
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 277183Recruiting
Namur, Belgium
Herlev Hospital /ID# 276831Recruiting
Herlev, Capital Region, Denmark
Aalborg University Hospital /ID# 276435Recruiting
Aalborg, North Denmark, Denmark
Odense University Hospital /ID# 276462Recruiting
Odense, Region Syddanmark, Denmark
Strasbourg Oncologie Liberale /ID# 276698Recruiting
Strasbourg, Bas-Rhin, France
Centre Georges François Leclerc /ID# 276737Recruiting
Dijon, Bourgogne-Franche-Comté, France
Centre Francois Baclesse /ID# 276709Recruiting
Caen, Calvados, France
Hopital Prive Des Cotes D'Armor /ID# 276706Recruiting
Plérin, Cotes-d Armor, France
Institut Bergonie /ID# 276696Recruiting
Bordeaux, Gironde, France
Institut Curie -Site Saint-Cloud /ID# 276850Recruiting
Saint-Cloud, Hauts-de-Seine, France
Institut Godinot /ID# 276849Recruiting
Reims, Marne, France
CHU de Limoges site CHU Dupuytren 1 /ID# 276851Recruiting
Limoges, New Aquitaine, France
IUCT Oncopole /ID# 276705Recruiting
Toulouse, Occitanie, France
Centre Antoine-Lacassagne /ID# 276708Recruiting
Nice, Provence-Alpes-Côte d'Azur Region, France
Centre Leon Berard /ID# 276710Recruiting
Lyon, Rhone, France
Institut du Cancer Avignon Provence - Sainte Catherine /ID# 276692Recruiting
Avignon, Vaucluse, France
Institut Gustave Roussy /ID# 276712Recruiting
Villejuif, Île-de-France Region, France
National Cancer Center /ID# 276283Recruiting
Goyang-si, Gyeonggido, South Korea
Seoul National University Bundang Hospital /ID# 276280Recruiting
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 276182Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 276266Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 276955Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 276261Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Korea University Guro Hospital /ID# 276194Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Complejo Hospitalario Universitario A Coruña /ID# 276416Recruiting
A Coruña, A Coruna, Spain
Hospital Universitario Marques de Valdecilla /ID# 276415Recruiting
Santander, Cantabria, Spain
Hospital Universitario Donostia /ID# 276404Recruiting
Donostia / San Sebastian, Guipuzcoa, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 276438Recruiting
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Virgen del Rocio /ID# 276426Recruiting
Seville, Sevilla, Spain
Hospital Universitari Vall d'Hebron /ID# 276478Recruiting
Barcelona, Spain
Hospital Clinic de Barcelona /ID# 276412Recruiting
Barcelona, Spain
Institut Català D'Oncologia (Ico) - Girona /ID# 276410Recruiting
Girona, Spain
Clinica Universidad de Navarra - Madrid /ID# 276411Recruiting
Madrid, Spain
Hospital Clinico San Carlos. /ID# 276407Recruiting
Madrid, Spain
Instituto Valenciano de Oncología /ID# 276413Recruiting
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 276406Recruiting
Zaragoza, Spain
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 · TrialPath