Ivonescimab Prior to Surgery for the Treatment of High-Risk Localized Clear Cell Renal Cell Cancer (NCT07226544) | Clinical Trial Compass
RecruitingPhase 2
Ivonescimab Prior to Surgery for the Treatment of High-Risk Localized Clear Cell Renal Cell Cancer
United States31 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by body surface area \[BSA\] is not required for eGFR)
* Urine protein \< 2+ or 24-hour urine protein quantification \< 1.0 g
* Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); For patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL ≤ 3 × ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; For patients with liver metastases, AST and ALT…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing ivonescimab as a treatment given before surgery for clear cell renal cell carcinoma — can you explain what ivonescimab is and how giving it before surgery might help compared to going straight to removing the tumor?
2Since this is a Phase 2 trial, what does that mean for how much is already known about ivonescimab's safety and effectiveness in kidney cancer patients like me?
3The trial is measuring how many patients' tumors respond to ivonescimab before surgery — based on my specific stage (Stage II, III, or IV), what would a meaningful response actually look like, and how might that change my surgical options?
4Are there standard pre-surgical or post-surgical treatment options already available for high-risk localized clear cell renal cell carcinoma that I should consider first before deciding whether a trial like this makes sense for me?
5What are the logistical demands of this trial — how many visits, how long would treatment before surgery take, and how might participating affect the timing of my operation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients achieving a best overall response (ORR)
Timeframe: Up to 2 years after completion of study treatment