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)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (16 items).
Location: UC San Diego Health - Moores Cancer Center /ID# 277574 โ La Jolla, California
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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 FRฮฑ-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 FRฮฑ-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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (83 Sites)
- UC San Diego Health - Moores Cancer Center /ID# 277574 โ La Jolla, California
- Sansum Clinic - Solvang /ID# 277712 โ Solvang, California
- University of Florida College of Medicine /ID# 278348 โ Gainesville, Florida
- Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623 โ Orlando, Florida
- Florida Cancer Specialists - North /ID# 278626 โ St. Petersburg, Florida
- Florida Cancer Specialists - East /ID# 278605 โ West Palm Beach, Florida
- Baptist Health Lexington /ID# 278267 โ Lexington, Kentucky
- Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440 โ Baton Rouge, Louisiana
- Maine Medical Center - Scarborough Campus /ID# 277205 โ Scarborough, Maine
- UMass Memorial Medical Center - Belmont Street /ID# 278628 โ Worcester, Massachusetts
- Karmanos Cancer Institute - Detroit /ID# 277085 โ Detroit, Michigan
- Intermountain Health - Intermountain Health West End Clinic /ID# 278470 โ Billings, Montana
- Md Anderson Cancer Center At Cooper /ID# 278390 โ Camden, New Jersey
- SUNY Upstate Medical University - Syracuse /ID# 277245 โ Syracuse, New York
- FirstHealth of the Carolinas- Speciality Center /ID# 278636 โ Pinehurst, North Carolina
- Jamescare Gynecologic Oncology At Mill Run /ID# 277951 โ Hilliard, Ohio
- Willamette Valley Cancer Institute and Research Center /ID# 277714 โ Eugene, Oregon
- Penn Medicine University of Pennsylvania Health System /ID# 277963 โ Philadelphia, Pennsylvania
- Western Pennsylvania Gynecologic Oncology /ID# 278632 โ Pittsburgh, Pennsylvania
- Avera Cancer Institute - Sioux Falls /ID# 278627 โ Sioux Falls, South Dakota
- University Of Tennessee Medical Center /ID# 278225 โ Knoxville, Tennessee
- Texas Oncology - Abilene - Antilley Road /ID# 277739 โ Abilene, Texas
- Texas Oncology - Fort Worth Cancer Center /ID# 277989 โ Fort Worth, Texas
- Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735 โ San Antonio, Texas
- Texas Oncology - The Woodlands /ID# 277926 โ The Woodlands, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.