Study on Adaptive Immunotherapy with VEGFR-TKI for Patients with Advanced Kidney Cancer

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

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).

Patient Parameters

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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