Condition: Ovarian Cancer · Fallopian Tube · Primary Peritoneal Cancer · Sponsor: University of Alabama at Birmingham
The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT and after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of mirvetuximab + carboplatin for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate and the patient will be declared a screen failure. Patients with BRCA mutations ar…
This description comes directly from the study's public registry record.
Rebecca Arend, M.D. · 205-934-4986 · rarend@uabmc.edu
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham Womens & Infants Center | Birmingham, Alabama, United States | Recruiting |
| University of California San Francisco | San Francisco, California, United States | Recruiting |
| University of Minnesota - Masonic Cancer Center | Minneapolis, Minnesota, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| University of Mississippi Medical Center | Oxford, Mississippi, United States | Recruiting |
| Ohio State University | Columbus, Ohio, United States | Recruiting |
| University of Oklahoma | Oklahoma City, Oklahoma, United States | Recruiting |
| Allegheny Health Network | Pittsburgh, Pennsylvania, United States | Recruiting |
| University of Virginia | Richmond, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04606914