Study on Ivonescimab Before Surgery for Treating High-Risk Localized Clear Cell Kidney Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07226544

Provider View

This clinical trial is exploring how well the drug ivonescimab works when given before surgery to patients with high-risk clear cell kidney cancer that hasn't spread. Ivonescimab is an immunotherapy that may help the immune system attack cancer and stop it from growing.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of ivonescimab, an immunotherapy drug, when used before surgery in patients with high-risk clear cell kidney cancer that hasn't spread to other parts of the body. Ivonescimab may help the immune system attack cancer cells and block the growth of new blood vessels that tumors need to grow. By giving ivonescimab before surgery, the goal is to shrink the tumor, making it easier to remove.

Description

The main goal of this study is to see how well ivonescimab works in shrinking tumors in patients with high-risk localized kidney cancer who are scheduled for surgery. Researchers also want to understand the side effects of ivonescimab and how well patients can undergo surgery after receiving the drug.

Participants will receive ivonescimab through an IV every three weeks for a total of four cycles, unless the cancer progresses or side effects become too severe. After completing the ivonescimab treatment, patients will have surgery to remove the kidney tumor. Throughout the study, patients will have various tests, including heart scans, biopsies, and CT scans, to monitor their health and the cancer's response to treatment.

After the treatment, patients will have follow-up visits every 12 weeks for two years, and then as needed, to check on their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of clear cell kidney cancer.
  • High-risk cancer that hasn't spread, based on specific medical criteria.
  • Eligible for surgery to remove the kidney tumor.
  • Cancer that can be measured using standard criteria.
  • Good overall health with a performance status of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • Adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.5 x 10^9/L.
    • Platelet count of at least 100 x 10^9/L.
    • Hemoglobin level of at least 9.0 g/dL.
    • Kidney function with creatinine clearance of at least 50 mL/min.
    • Low levels of protein in urine.
    • Liver function within specified limits.
    • Normal blood clotting times unless on stable anticoagulation.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.
  • Men must agree to use condoms and ensure their partners use effective contraception during and after treatment.
  • Adults aged 18 years or older.

Exclusion Criteria

  • Previous treatment for kidney cancer.
  • Recent major surgery or serious injury, or plans for major surgery soon after starting the study.
  • History of bleeding disorders or significant bleeding risk.
  • Uncontrolled high blood pressure.
  • Active autoimmune or lung disease requiring treatment within the past two years, except for certain conditions like thyroid or insulin replacement.
  • History of major heart disease or other serious medical conditions within the past year.
  • Evidence of cancer spread to other parts of the body.
  • Active infections or recent severe infections.
  • Pre-existing nerve damage or uncontrolled fluid buildup in the body.
  • History of inflammatory bowel disease or other chronic digestive issues.
  • Uncontrolled HIV or active hepatitis B or C infections.
  • Known allergies to study drugs or components.
  • Any condition that might interfere with the study or pose a risk to the patient.
  • Women who are pregnant or breastfeeding.
  • History of severe side effects from similar immunotherapy treatments.

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