A Phase II Study of Neoadjuvant Ivonescimab in Patients With High-Risk, Localized RCC
City of Hope Medical Center
Summary
This phase II trial studies how well ivonescimab works prior to surgery in treating patients with high-risk clear cell kidney (renal cell) cancer that has not spread to other parts of the body (localized). 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. Ivonescimab may also stop or slow the cancer by blocking the growth of new blood vessels necessary for tumor growth. Giving ivonescimab before standard surgery may make the tumor smaller.
Description
PRIMARY OBJECTIVE: I. To define the response rate associated with ivonescimab in patients with high-risk, localized renal cell carcinoma (RCC) planned for nephrectomy. SECONDARY OBJECTIVES: I. To define toxicity associated with ivonescimab in this setting. II. To define the feasibility of surgery following systemic therapy with ivonescimab. III. To determine the pathologic response rate following ivonescimab. IV. To characterize KIM-1 expression before and after ivonescimab. V. To determine survival outcomes following ivonescimab. EXPLORATORY OBJECTIVES: I. To characterize the expression…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologic confirmation of clear cell RCC * High-risk disease defined as cT2G3-4N0M0, cT3GanyN0M0, cT4GanyN0M0, cTanyGanyN+M0 (Grade determined by biopsy) * Candidate for partial or complete nephrectomy that extirpates all tumor tissue as part of treatment plan * Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L (no blood transfusions or growth factor therapy used within 7 days of the screening complete blo…
Interventions
- ProcedureBiopsy Procedure
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- ProcedureEchocardiography Test
Undergo ECHO
- BiologicalIvonescimab
Given IV
- ProcedureNephrectomy
Undergo SOC nephrectomy
- OtherQuestionnaire Administration
Ancillary studies
Location
- City of Hope Medical CenterDuarte, California