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
Sponsor: City of Hope Medical Center + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Proportion of patients achieving a best overall response (ORR)
Time frame: Up to 2 years after completion of study treatment
Secondary Endpoints
Incidence of adverse events (AEs)
Rate of completion of surgery
Pathologic complete response (pCR)
Eligibility Criteria
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 blood count \[CBC\]) * Platelet count ≥ 100 × 10\^9/L (no blood transfusions or growth factor therapy used within 7 days of the screening CBC) * Hemoglobin ≥ 9.0 g/dL (no blood transfusions or growth factor therapy used within 7 days of the screening CBC) * Creatinine clearance (CrCL) ≥ 50 mL/min using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min using …
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