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Clinical Trials in the USA / NCT07059845
Recruiting Phase 2

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 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Phase 2
Started
2025-11-13
Last updated
2026-08-21

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Mirvetuximab SoravtansineBevacizumabCarboplatin

Mirvetuximab Soravtansine: Intravenous (IV) infusion

Bevacizumab: IV Infusion

Carboplatin: IV Infusion

Study 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

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (83)

FacilityCityRegionStatus
UC San Diego Health - Moores Cancer Center /ID# 277574 La Jolla California Recruiting
Sansum Clinic - Solvang /ID# 277712 Solvang California Active Not Recruiting
University of Florida College of Medicine /ID# 278348 Gainesville Florida Recruiting
Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623 Orlando Florida Recruiting
Florida Cancer Specialists - North /ID# 278626 St. Petersburg Florida Recruiting
Florida Cancer Specialists - East /ID# 278605 West Palm Beach Florida Recruiting
Baptist Health Lexington /ID# 278267 Lexington Kentucky Recruiting
Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440 Baton Rouge Louisiana Recruiting
Maine Medical Center - Scarborough Campus /ID# 277205 Scarborough Maine Recruiting
UMass Memorial Medical Center - Belmont Street /ID# 278628 Worcester Massachusetts Recruiting
Karmanos Cancer Institute - Detroit /ID# 277085 Detroit Michigan Recruiting
Intermountain Health - Intermountain Health West End Clinic /ID# 278470 Billings Montana Recruiting
Md Anderson Cancer Center At Cooper /ID# 278390 Camden New Jersey Recruiting
SUNY Upstate Medical University - Syracuse /ID# 277245 Syracuse New York Recruiting
FirstHealth of the Carolinas- Speciality Center /ID# 278636 Pinehurst North Carolina Recruiting
Jamescare Gynecologic Oncology At Mill Run /ID# 277951 Hilliard Ohio Recruiting
Willamette Valley Cancer Institute and Research Center /ID# 277714 Eugene Oregon Recruiting
Penn Medicine University of Pennsylvania Health System /ID# 277963 Philadelphia Pennsylvania Recruiting
Western Pennsylvania Gynecologic Oncology /ID# 278632 Pittsburgh Pennsylvania Recruiting
Avera Cancer Institute - Sioux Falls /ID# 278627 Sioux Falls South Dakota Recruiting
University Of Tennessee Medical Center /ID# 278225 Knoxville Tennessee Recruiting
Texas Oncology - Abilene - Antilley Road /ID# 277739 Abilene Texas Recruiting
Texas Oncology - Fort Worth Cancer Center /ID# 277989 Fort Worth Texas Recruiting
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735 San Antonio Texas Recruiting
Texas Oncology - The Woodlands /ID# 277926 The Woodlands Texas Recruiting
Texas Oncology - Northeast Texas /ID# 277737 Tyler Texas Recruiting
Virginia Mason Hospital and Medical Center /ID# 277259 Seattle Washington Recruiting
West Virginia University Hospitals /ID# 278965 Morgantown West Virginia Recruiting
St. George Private Hospital /ID# 276570 Kogarah New South Wales Recruiting
Chris O'Brien Lifehouse /ID# 276337 Sydney New South Wales Recruiting
Icon Cancer Centre Wesley /ID# 277199 Auchenflower Queensland Recruiting
Burnside War Memorial Hospital /ID# 277602 Adelaide South Australia Recruiting
Icon Cancer Centre Hobart /ID# 277688 Hobart Tasmania Recruiting
Monash Health - Monash Medical Centre - Clayton /ID# 276984 Clayton Victoria Recruiting
Barwon Health /ID# 277297 Geelong Victoria Recruiting
Austin Hospital /ID# 276534 Melbourne Victoria Recruiting
Epworth Hospital - Richmond /ID# 276347 Richmond Victoria Recruiting
St. John Of God Subiaco Hospital /ID# 277174 Subiaco Western Australia Recruiting
Cliniques Universitaires UCL Saint-Luc /ID# 276321 Brussels Brussels Capital Recruiting
AZ Maria Middelares /ID# 276325 Ghent Oost-Vlaanderen Recruiting

+ 43 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07059845 on ClinicalTrials.gov ↗ ← All trials in the USA