IvoLoC Trial: A Phase II Trial Evaluating the Efficacy of Ivonescimab in Metastatic Endocrine Refractory HR-positive HER2-negative or Triple Negative Invasive Lobular Carcinoma
M.D. Anderson Cancer Center
Summary
To learn if ivonescimab can help to control endocrine-refractory HR+ HER2- and/or TN mILC.
Description
Primary Objectives To evaluate the 6-month PFS of ivonescimab in endocrine-refractory HR+ HER2- or Triple Negative (TN) mILC Secondary Objectives * To evaluate the 12-month PFS and median PFS (mPFS) of ivonescimab inhibitor in endocrine-refractory HR+ HER2- and TN mILC * To evaluate the overall response rate (ORR) of ivonescimab in endocrine-refractory HR+ HER2- and TN mILC * To assess the disease control rate (DCR), duration of response (DOR) and overall survival (OS) * To evaluate the safety and tolerability of ivonescimab, as assessed by the National Cancer Institute Common Terminology Cr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18 years of age or older. * Historically confirmed invasive lobular cancer with negative E-cadherin staining by IHC. * Estrogen receptor (ER) positive (\>1%) or negative, progesterone receptor (PgR) positive or negative, and HER2-negative according to HER2 testing guidelines from the American Society of Clinical Oncology/College of American Pathologists. * Participants must be willing to undergo biopsy as required by the study if the tumor is safely accessible. * If ER+, participant must be endocrine refractory as per the treating oncologist assessment and has been expos…
Interventions
- DrugIvonescimab
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas