Study Phase: Phase II
Sponsor: Abbvie/GOG Foundation
ClinicalTrials.gov Identifier: https://clinicaltrials.gov/study/NCT06890338
Disease Focus: Advanced stage Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancers
Principal Investigator: Michelle Rowland, MD, PhD, MPH.
Clinical Research Coordinator: Lisa Gale, MSN, RN, CCRC
Study Overview
- This is a Phase II clinical trial testing a combination therapy.
- This study is for people with advanced ovarian, fallopian tube, or primary peritoneal cancer whose tumors have a protein called folate receptor alpha (FRα).
- The goal is to find out whether giving two medicines Mirvetuximab Soravtansine (MIRV) and Carboplatin before surgery is safe and effective in shrinking the cancer.
- In this study, MIRV is considered an experimental medicine and is being evaluated for its safety and effectiveness when given with carboplatin before surgery.
- MIRV is an experimental medicine designed to attach to cancer cells that have the FRα protein and deliver a cancer-killing drug directly to them.
- In this study, participants will receive MIRV together with Carboplatin through an IV once every three weeks for up to 6 to 9 treatment cycles before surgery.
- About 140 adults will take part across 80 locations in the United States, and the study will last about three years.
- Participants will have regular clinic visits, blood tests, and scans as part of their care. The treatment and monitoring schedule may require more clinic visits than standard treatment.
Eligibility
Who Can Join This Study
- Adults 18 years and older with advanced (stage III or IV) ovarian, fallopian tube, or primary peritoneal cancer that is high-grade serous type and shows high folate receptor alpha (FRα) levels may be able to join.
- Participants must be in good overall health (ECOG 0–1) and
- Considered suitable by their doctor to receive chemotherapy before surgery.
Who Cannot Join
- Participants with other cancer types (like clear cell, mucinous, or low-grade tumors).
- Participants who received prior cancer treatments for this disease (except one carboplatin cycle)
- Participants with lung inflammation (pneumonitis), or serious eye conditions that affect vision cannot participate.
- Participants with another active cancer in the past 3 years are also not eligible, unless it was a minor, well-treated skin or in-situ cancer.
Note: The eligibility listed above do not represent the complete list of criteria. Final eligibility will be determined by the study team after a complete review, in coordination with your cancer care team.
Enrollment Information
Status: Recruiting Patients
See if you qualify. Contact us: (844) 673- 4467 or Email: sfmc.clinicaltrials@osfhealthcare.org