Study Details

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Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer

The purpose of this study is to determine if MIRV plus Bev can help to prevent your cancer from returning or delaying your cancer's return.

Age & Gender

18 years ~ 99 years
Female

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To participate on the study, you will frequently meet with a member of the study team in addition to your oncology care team. The study also involves study drugs, physical exams, blood and urine tests, pregnancy tests, quality of life questionnaire, Electrocardiogram (ECG), Computerized Tomography scan (CT scan)/Magnetic Resonance Imaging (MRI); Eye Exam, Eye Drops, telephone assessments (after treatment discontinuation, every 4 months for two years and every 6 months thereafter).

Incentives

In-person visits:
4-8

Phone or online visits:
4-6 (follow up assessments )

Total length of participation:
up to 2 years

Looking for Specific Volunteers

Able to participate:

you have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cance
are willing to provide an archival tumor tissue block or slides, or must undergo a procedure to obtain a new biopsy
you are of childbearing potential, you must have a negative pregnancy test within 4 days before the first dose of maintenance therapy
you are of childbearing potential (FCBP) you must agree to use highly effective contraceptive method(s) while on study medication and for at least 3 months
you have adequate hematologic, liver, and kidney functions

Not eligible if:

you have serious concurrent illness or clinically relevant active infection (HIV, Hepatitis B or C...)
you are pregnant or breastfeeding
you received prior treatment with MIRV or other FRα-targeting agents
you have a history of hemorrhagic or ischemic stroke within 6 months before enrollment
you have active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Linda Van Le
Obstetrics and Gynecology - Gynecologic Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Other Cancers, Ovarian)

IRB Number

22-2935

ClinicalTrials.gov

NCT05445778