Study Details

Open

IMGN853-0420: Multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers following 1 prior line of platinum-based chemotherapy

To determine if MIRV, an experimental drug, when given with and following treatment with carboplatin, is effective at managing your type of cancer and to find out what effects, both good and/or bad, MIRV may have on you and your type of cancer when given with and following treatment with carboplatin.

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

The study involves study drug infusions, blood draws and urine tests , CT/MRI scans, pregnancy tests, eye exams, use of eye drops, Physical exams.

Incentives

mileage and hotel stay reimbursement, study medication

In-person visits:
12

Total length of participation:
2 years

Looking for Specific Volunteers

Able to participate:

have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
have adequate hematologic, liver, and kidney functions
willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
have relapsed after 1 prior line of platinum-based chemotherapy.
have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of platinum-based chemotherapy

Not eligible if:

have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors or low-grade/borderline ovarian tumor
have more than one line of prior chemotherapy.
have active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring
Have serious concurrent illness or clinically relevant active infection
Females who are pregnant or breastfeeding

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

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

Primary Visit Location

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 (Uterine (endometrial), Ovarian)

IRB Number

23-0087

ClinicalTrials.gov

NCT05456685