BridgeMD
New treatment option for Advanced High-Grade Epithelial Ovarian Cancer
Official title A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
ClinicalTrials.gov ID: NCT06682988
What this study is testing
What is Mirvetuximab Soravtansine?
Mirvetuximab Soravtansine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced high-grade epithelial ovarian cancer.
Also referred to as MIRV, IMGN853.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Both Cohorts
- Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
- Participants with platinum-resistant disease:
- Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or...
- Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum.
You likely can't join if
- Both Cohorts
- Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or...
- Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or...
- Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol
- Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.
See the full eligibility criteria
- Both Cohorts
- Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
- Participants with platinum-resistant disease:
- Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD)...
- Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum.
- Participants with progression diagnosed radiographically on or after their most recent line of therapy.
- Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
- Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).
- Both Cohorts
- Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
- Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of...
- Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol
- Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- Edgewood, Kentucky, United States
- Lexington, Kentucky, United States
- Worcester, Massachusetts, United States
- Detroit, Michigan, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Blacktown, New South Wales, Australia
- Lambton Heights, New South Wales, Australia
- Brisbane, Queensland, Australia
- Chermside, Queensland, Australia
- Ballarat, Victoria, Australia
- Clayton, Victoria, Australia
- Nedlands, Western Australia, Australia
- Brasschaat, Antwerpen, Belgium
- Brussels, Brussels Capital, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Leuven, Vlaams-Brabant, Belgium
- Roeselare, West-Vlaanderen, Belgium
- Caen, Calvados, France
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; Edgewood, Kentucky, United States; Lexington, Kentucky, United States; Worcester, Massachusetts, United States; Detroit, Michigan, United States; Pittsburgh, Pennsylvania, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.