UCLA L-11: A Phase II Trial of Ivonescimab for Previously Treated Thymic Carcinoma
Jonsson Comprehensive Cancer Center
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.
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 asso…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female ≥ 18 years of age and willing and able to provide informed consent * Cytologically or histologically confirmed thymic carcinoma, which is incurable * Received prior systemic therapy for thymic carcinoma, or is ineligible for or refuses other therapies * Measurable disease, as per RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L * Platelets ≥ 100 × 10\^9/L * Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated cre…
Interventions
- ProcedureBiopsy Procedure
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo collection of blood and urine samples
- ProcedureComputed Tomography
Undergo CT
- BiologicalIvonescimab
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- OtherQuestionnaire Administration
Ancillary studies
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California