Study Details

Open

Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (EOC):Carboplatin and Mirvetuximab Soravtansine in a Neoadjuvant Setting

To evaluate the anti-tumor activity of carboplatin + MIRV in newly diagnosed subjects with advanced-stage (≥ 75%, ≥ 2+) serous EOC as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 imaging response.

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

You will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The study also involves interviews and questionnaires, local labs and exams, central labs, and treatment.

Incentives

In-person visits:
up to 15

Total length of participation:
up to 3 years

Looking for Specific Volunteers

Able to participate:

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Not treated with a prior systemic anti-cancer therapy other than 1 cycle of single-agent carboplatin, which may be administered at the investigator's discretion while awaiting
Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
Measurable disease by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 criteria.
18 Years and older

Not eligible if:

you have Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.
you have previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after
you have been previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle
You have History of other malignancy within 3 years prior to signing study consent
You have some specific ocular history and/or concurrent disorders

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

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

Primary Visit Location

Additional Study Information

Principal Investigator

Olivia Lara
Obstetrics and Gynecology - Gynecologic Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Other Cancers, Ovarian)

IRB Number

25-0567

ClinicalTrials.gov

NCT06890338