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.
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
Prior systemic anti-tumor treatment for RCC
Major surgical procedures or serious trauma within 4 weeks prior to enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment
Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution
Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
Single group
Biopsy Procedure
Procedure/SurgeryUndergo biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Echocardiography Test
Procedure/SurgeryUndergo ECHO
Ivonescimab
Biological/VaccineGiven IV
Nephrectomy
Procedure/SurgeryUndergo SOC nephrectomy
Questionnaire Administration
Other interventionAncillary studies
Proportion of patients achieving a best overall response (ORR)
Objective response is defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors. The ORR will be estimated as the proportion of patients who have CR or PR during the treatment, along with the 90% and 95% exact confidence intervals.
Incidence of adverse events (AEs)
Will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0. Safety and toxicity will be assessed by tabulating the toxicity type, frequency, grades and proportion identified in the participants treated on the trial. Binary proportions and associated confidence intervals will be calculated.
Rate of completion of surgery
Proportion of patients who undergo the planned nephrectomy
Pathologic complete response (pCR)
pCR defined as 0% viable tumor cells in the nephrectomy specimen and sampled regional lymph nodes at the time of surgery, assessed per NCI standards and confirmed by central pathology review. The pCR rate will be estimated as the proportion of all treated patients who undergo surgery and have pCR; patients who do not undergo surgery or have an unevaluable specimen will be considered non-responders. Will be estimated as the proportion of patients who have CR, major response, or PR, after the treatment, along with confidence intervals.
Peri-treatment KIM-1 levels
Stored plasma will be analyzed for KIM-1 and other exploratory analytes.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
