REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
18 Years and older, Female
STRO-002-GM3 (primary)
NCI-2023-04597
APGOT-OV9
ENGOT-OV79
GEICO-134-O
GOG-3086
Summary
A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus
IC chemotherapy in women with ovarian cancer (including fallopian tube or primary
peritoneal cancers) expressing FOLR1.
Objectives
This is a randomized, multicenter, international, open-label, 2-part, Phase 2/3 study
designed to assess the efficacy and safety of luveltamab tazevibulin versus IC
chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer
expressing FOLR1.
Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (Cohort A and Cohort B),
with subjects randomized 1:1. Part 1 will be used to select the optimized dosing regimen.
Part 2 will further evaluate the efficacy and safety of the selected dosing regimen
versus IC chemotherapy.
Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion
time every 3 weeks.
Eligibility
- High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer
- Age = 18 years
- ECOG performance status 0 to 1
- Positive FOLR1 expression per central laboratory testing
- Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens
- Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication
- At least 1 measurable target lesion per RECIST v1.1
- Adequate organ function
Treatment Sites in Georgia
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