Ivonescimab for the Treatment of Thymic Cancer
brief summary
This phase II trial tests how well ivonescimab works in treating patients with thymic carcinoma. Immunotherapy with monoclonal antibodies, such as ivonescimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
detailed description
PRIMARY OBJECTIVES:
I. Measure anti-tumor effect of ivonescimab for thymic carcinoma (TC) as measured by overall response rate (ORR), which is defined as complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
II. Assess the safety and tolerability of ivonescimab for thymic carcinoma.
SECONDARY OBJECTIVE:
I. To evaluate the efficacy of ivonescimab as measured progression free survival (PFS), duration of response (DOR), time to response (TTR) and overall survival (OS).
EXPLORATORY OBJECTIVE:
I. Assess potential biomarkers associated with response from liquid biopsies and archival tissue samples.
OUTLINE:
Patients receive ivonescimab intravenously (IV) over 60-120 minutes on day 1 of each cycle. Cycles repeat once every 3 weeks (Q3W) for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and collection of blood and urine samples throughout the study. Patients may undergo magnetic resonance imaging (MRI) throughout the study if indicated and may optionally undergo a biopsy at the end of treatment.
After completion of study treatment, patients are followed up every 6 weeks through week 24, and then every 12 weeks thereafter for up to 1 year.
official title
UCLA L-11: A Phase II Trial of Ivonescimab for Previously Treated Thymic Carcinoma