Last updated on April 2018

Study of BEvacizumab in Combination With ATezolizumab in Patients With Untreated Melanoma Brain Metastases


Brief description of study

The goal of this clinical research study is to learn if atezolizumab and bevacizumab can help to control the disease in patients with cancer that has spread to the brain.

The safety of this drug combination will also be studied.

This is an investigational study. Bevacizumab is FDA approved and commercially available to treat certain types of cervical, ovarian, Fallopian tube, peritoneal, colorectal, lung, brain, and kidney cancer. Atezolizumab is FDA approved and commercially available to treat certain types of lung and urinary system cancer. The combination of bevacizumab and atezolizumab is investigational. The study doctor can explain how the study drugs are designed to work.

Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed Study Description

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive atezolizumab by vein over 30-60 minutes (+/-10-15 minutes). Bevacizumab will then be given by vein over 30, 60, or 90 minutes (+/-10-15 minutes).

You may be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Length of Treatment:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Study Visits:

On Day 1 of each cycle:

  • You will have a physical exam.
  • Blood (about 2 tablespoons) and urine will be collected for routine tests.
  • If you can become pregnant, urine will be collected for a pregnancy test.

On Day 1 of Cycle 2, 3, and every 2 cycles after that (Cycles 5, 7, and so on), you will have a CT scan, PET-CT scan, and/or MRI to check the status of the disease. In Cycles 2, 3, and 5 only, you will have an additional MRI to look for biomarkers that may be related to an immune response.

On Day 1 of Cycle 3, if you have extracranial disease that can have a biopsy, you will have a tumor biopsy for biomarker and PD testing.

On Day 1 of Cycles 3, 5, and every 2 cycles after that, blood (about 3 tablespoons) will be drawn for biomarker testing.

On Day 1 of Cycles 5, 9, and every 4 cycles after that (Cycles 13, 17, and so on), if your main language is English, you will have a neurocognitive exam. You will also complete the symptom and quality-of-life questionnaires.

End of Treatment Visit:

After you stop the study drugs:

  • You will have a physical exam.
  • Blood (about 5 tablespoons) will be drawn for routine and biomarker testing.
  • Urine will be collected for routine tests.
  • You will have an EKG.
  • If you can become pregnant, urine will be collected for a pregnancy test.

Follow-Up:

Ninety (90) days after your last study drug dose, or sooner if you start another anti-cancer

therapy
  • You will have a physical exam.
  • Blood (about 2 tablespoons) and urine will be collected for routine tests.
  • You will have an EKG.
  • If you can become pregnant, urine will be collected for a pregnancy test.

Long-Term Follow-Up:

Every 3 months, the study staff will call and ask you about any symptoms and health problems you have and any new drugs or changes in existing drugs that you are taking. The calls should last up to 15 minutes.

Clinical Study Identifier: NCT03175432

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University of Texas MD Anderson Cancer Center
Houston, TX United States
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