Study on Bevacizumab, Erlotinib, and Atezolizumab Combination for Advanced Kidney Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04981509

Provider View

This clinical trial is testing a combination of three drugs—bevacizumab, erlotinib, and atezolizumab—to see if they can help control advanced kidney cancer that has spread. The study aims to find out if this combination can stabilize or shrink tumors in patients with hereditary leiomyomatosis and kidney cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced kidney cancer using a combination of three drugs: bevacizumab, erlotinib, and atezolizumab. Bevacizumab works by stopping the growth of blood vessels that feed tumors, erlotinib blocks a protein that helps cancer cells grow, and atezolizumab helps the immune system attack cancer cells. The goal is to see if this combination can help control the cancer by slowing its growth or shrinking the tumors.

Description

The main goal of this study is to see how well the combination of bevacizumab, erlotinib, and atezolizumab works in treating advanced kidney cancer, specifically in patients with hereditary leiomyomatosis and renal cell cancer (HLRCC) or advanced papillary renal cell cancer. Researchers will look at how many patients have a complete response, meaning no signs of cancer are found after treatment.

Secondary goals include checking the safety of the treatment, how many patients have a partial response (tumors shrink but don't disappear), and how long patients live without the cancer getting worse. The study will also explore how the treatment affects the immune system and if certain genetic changes in the cancer affect the treatment's success.

Participants will receive bevacizumab and atezolizumab through an IV and take erlotinib pills daily. The treatment cycles repeat every 21 days as long as the cancer doesn't progress and side effects are manageable. Patients will have regular scans and blood tests to monitor their response to the treatment. After finishing the study treatment, patients will have follow-up visits every six months.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with hereditary leiomyomatosis and renal cell cancer (HLRCC) or papillary renal cell carcinoma.
  • Have advanced kidney cancer with measurable tumors.
  • No more than two previous treatments targeting the VEGF pathway and no prior treatment with bevacizumab or PD-1/PD-L1 inhibitors.
  • Aged 12 years or older.
  • Good overall health with a performance status score of 0 to 2.
  • Adequate blood cell counts and organ function based on specific lab tests.
  • HIV-positive patients must have an undetectable viral load on treatment.
  • Hepatitis B and C infections must be under control or treated.
  • Treated brain metastases must be stable for at least 3 months.
  • No other health conditions that would interfere with the study.
  • Agree to use effective birth control during and after the study.
  • Willing to provide tumor samples for research purposes.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Recent treatment for kidney cancer within 4 weeks or major surgery within 28 days.
  • Unresolved side effects from previous cancer treatments.
  • Recent use of other investigational drugs or immunosuppressive medications.
  • History of autoimmune diseases or severe allergic reactions to similar drugs.
  • Active infections or recent live vaccinations.
  • Uncontrolled high blood pressure or heart conditions.
  • Pregnant or breastfeeding women.
  • Use of certain medications that cannot be stopped during the study.
  • History of severe bleeding disorders or recent blood clots.
  • Current use of high-dose aspirin or blood thinners.

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