NCT07226544

Ivonescimab Prior to Surgery for the Treatment of High-Risk Localized Clear Cell Renal Cell Cancer

A Phase II Study of Neoadjuvant Ivonescimab in Patients With High-Risk, Localized RCC

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 of validated genomic signatures (including those derived from IMmotion151) in baseline biopsy and nephrectomy tissue (i.e., before and after therapy with ivonescimab). II. To evaluate patient-reported quality of life using the FKSI-23 instrument at baseline, pre-surgery, and at post-surgical follow-up time points. OUTLINE: Patients receive ivonescimab intravenously (IV) over 60-120 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Between 4-10 weeks after completion of ivonescimab treatment, patients then undergo standard of care (SOC) nephrectomy. Patients also undergo echocardiogram (ECHO) during screening, biopsy prior to treatment start, and computed tomography (CT) and blood sample collection throughout the study. After completion of study treatment, patients are followed every 12 weeks for a total of 2 years and then periodically at the discretion of the investigator.

Conditions

• Localized Clear Cell Renal Cell Carcinoma
• Resectable Clear Cell Renal Cell Carcinoma
• Stage II Renal Cell Cancer AJCC v8
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Echocardiography Test	Undergo ECHO
BIOLOGICAL	Ivonescimab	Given IV
PROCEDURE	Nephrectomy	Undergo SOC nephrectomy
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2026-06-08
• Primary completion: 2027-09-08
• Completion: 2027-09-08
• First posted: 2025-11-10
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study