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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Substudy 1, 2, and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3) — Up to Approximately 40 Months
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug. - Substudy 1, 2, and 3: Number of Participants with TEAEs Leading to Discontinuation — Up to Approximately 40 Months
TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug. - Substudy 1, 2, and 3: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2) — Up to Approximately 40 Months
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. - Substudy 1, 2, and 3: Overall Response (OR) as Assessed by the Investigator per RECIST v1.1 — Up to Approximately 40 Months
OR is defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Substudy 1: Progression free survival (PFS) as Assessed by the Investigator per RECIST v1.1 — Up to Approximately 40 Months
PFS is defined as the time from the date of randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause, whichever occurs first.
Trial sites (85)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Columbia University Medical Center /ID# 277990 | New York | New York | 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 |
| University of Texas - Southwestern Medical Center /ID# 278289 | Dallas | 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 HealthCare /ID# 276347 | Richmond | Victoria | Recruiting |
| St. John Of God Subiaco Hospital /ID# 277174 | Subiaco | Western Australia | Recruiting |
+ 45 more sites — see the full list on the official registry below.
On this site
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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 South Korea