Last updated on September 2017

Tremelimumab (Anti-CTLA-4) Plus Durvalumab (MEDI4736) (Anti-PD-L1) in the Treatment of Resectable Colorectal Cancer Liver Metastases


Brief description of study

The goal of this clinical research study is to learn if tremelimumab in combination with MEDI4736 can help to control colorectal cancer that has spread to the liver. The safety of these drugs will also be studied. This is an investigational study. MEDI4736 and tremelimumab are not FDA approved or commercially available. They are currently being used for research purposes only. The study doctor can explain how the study drugs are designed to work. Up to 35 participants will take part in this study. All will be enrolled 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 tremelimumab by vein over about 1 hour and MEDI4736 by vein over about 4 hours during Week 11. After Week 11, you will receive MEDI4736 alone by vein over about 1 hour during Weeks 21, 25, 29, and 33. Between Weeks 15 and 17, you will have your already scheduled liver surgery. This means you will receive tremelimumab before your surgery and MEDI4736 after your surgery. Study Visits: During Week 1: - You will have a physical exam. - Blood (about 6 tablespoons) will be drawn for routine tests and for testing related to your immune system. - If you can become pregnant, part of the above routine blood sample will be used for a pregnancy test. Urine may also be collected for this test. During Week 4 : - You will have a physical exam. - Blood (about 6 teaspoons) will be drawn for routine tests and for testing related to your immune system. - You will have a CT scan. - If you can become pregnant, part of the above routine blood sample will be used for a pregnancy test. Urine may also be collected for this test. Between Weeks 4 and 8: - You will have a physical exam. - Blood (about 4 tablespoons) will be drawn for tests related to the immune system. - You will have liver surgery as part of your standard care. You will sign a separate consent form for this procedure. After your liver surgery Between 0-2 weeks after your liver surgery: - You will also have a physical exam. - Blood (about 7 tablespoons) will be drawn for routine tests, to check the status of the disease, and for tests related to your immune system. During Week 1: - You will have a physical exam. - Blood (about 4 teaspoons) will be drawn for routine tests. - If you can become pregnant, part of the above routine blood sample will be used for a pregnancy test. Urine may also be collected for this test. During Weeks 5 and 9: - You will have a physical exam. - Blood (about 4 teaspoons) will be drawn for routine tests. During Week 13 and every 14 weeks after that until 2 years: - You will have a physical exam. - Blood (about 8 teaspoons) will be drawn for routine tests and to check the status of the disease. - You will have a CT scan or MRI. At Week 17, instead of coming into the clinic, the study staff may call you to ask how you are doing. If you are called, it should last about 5-10 minutes. Length of Study: You may receive tremelimumab and MEDI4736 for 1 week and MEDI4736 alone for up to an additional 4 weeks. 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. Your participation on this study will be over after follow-up. Follow-Up: If you stop treatment for any reason, you will be asked to come to the hospital so your study doctor may check your health and follow up any ongoing side effects or discomfort until they get better. If the disease has gotten better or remained the same, your doctor will continue to check on the status of the disease as part of your standard of care, which may include imaging scans and/or blood draws for routine tests. The study staff will call you 2 times every year starting about 2 years after surgery to ask you how you are doing. These calls should last about 5-10 minutes. Follow-up will continue for 5 years or until you withdraw from the study, whichever happens first.

Clinical Study Identifier: NCT02754856

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Michael Overman, MD

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