Study on Adaptive Immunotherapy with VEGFR-TKI for Patients with Advanced Kidney Cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials ID:NCT06860386
This Phase II clinical trial is testing a new approach to treating advanced kidney cancer by using a flexible dosing method of a combination therapy called pembro-axi. The study focuses on patients with metastatic clear cell renal cell carcinoma (mccRCC).
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Program Overview
The purpose of this study is to evaluate a new treatment strategy for patients with advanced kidney cancer, specifically those with metastatic clear cell renal cell carcinoma (mccRCC). The trial will test the effectiveness and safety of a flexible dosing method using a combination of medications known as pembro-axi.
Eligibility Criteria
Inclusion Criteria
- Have advanced kidney cancer that cannot be surgically removed, specifically clear cell type.
- Be 18 years or older.
- Be in relatively good health, with a performance status score of 2 or less.
- Provide a tumor sample from a previous biopsy or be willing to undergo a new biopsy if needed.
- Have not received any prior treatment for metastatic clear cell kidney cancer.
- Have measurable cancer as defined by specific medical criteria.
- Have adequate blood, liver, and kidney function based on lab tests.
- Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during and after the study.
- Men and women must agree to use two forms of birth control during and after the study.
- Be able to understand and agree to the study requirements.
- Patients with well-controlled Hepatitis B, Hepatitis C, or HIV are eligible.
Exclusion Criteria
- Have had major surgery within the last 4 weeks or radiation therapy within the last 2 weeks.
- Have received previous treatments for kidney cancer.
- Have severe allergies to the study medications.
- Have an immune deficiency or are taking high doses of steroids or other immune-suppressing drugs.
- Have another active cancer that has required treatment in the last year.
- Have active cancer spread to the brain or spinal cord unless stable and treated.
- Have had lung inflammation requiring steroids in the past 6 months.
- Have an active infection needing treatment.
- Have uncontrolled HIV, Hepatitis B, or Hepatitis C.
- Have significant digestive issues affecting medication absorption.
- Have a heart condition or stroke within the last 6 months.
- Have poorly controlled high blood pressure.
- Have issues with wound healing or active bleeding.
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