Metastatic Melanoma Clinical Trial
Official title:
Phase II Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic Melanoma
You are being asked to take part in this study because you have advanced melanoma. The goal of this clinical research study is to learn if oral azacitidine (CC-486) and pembrolizumab (MK-3475) can help to control melanoma. The safety of this drug combination will also be studied. This is an investigational study. Azacitidine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia. Pembrolizumab is FDA approved and commercially available for the treatment of melanoma. It is considered investigational to use this drug combination to treat melanoma. The study doctor will explain how the study drugs are designed to work. Up to 71 participants will be enrolled in this study. All will take part at MD Anderson.
Study Drug Administration: Each study cycle is 3 weeks. You will take azacitidine by mouth 1 time each day on Days 1-14 of each cycle. You may be asked to complete a Pill Diary for this drug. On this Pill Diary you will record the date, time, and number of azacitidine tablets you took that day. You will bring the Pill Diary to each Study Visit while you are on this drug. You will receive pembrolizumab by vein over about 30 minutes on Day 1 of each cycle. Study Visits: On Day 1 of Cycles 1-3: - You will have a physical exam. - Blood (about 2½ teaspoons) will be drawn for routine tests. - During Cycle 1 (if it was not done at screening) and Cycle 3, blood (about 1 teaspoon) will be drawn to learn if the study drugs have affected the disease. - During Cycle 3 only, you will have 4 core needle tumor biopsies. - If you can become pregnant, part of the above routine blood sample or urine will be collected for a pregnancy test. On Day 1 of Cycle 4: - You will have a physical exam. - Blood (about 2½ teaspoons) will be drawn for routine tests and to learn if the study drugs have affected the disease. - If you can become pregnant, part of the above routine blood sample or urine will be collected for a pregnancy test. You will have an MRI or CT scan at the end of Cycle 4. On Day 1 of Cycle 5: - You will have a physical exam. - Blood (about 4 teaspoons) will be drawn for routine tests and to check the status of the disease. - You will have 4 core needle tumor biopsies. - If you can become pregnant, part of the above routine blood sample or urine will be collected for a pregnancy test. On Day 1 of Cycles 6 and beyond: - You will have a physical exam. - Blood (up to 3½ teaspoons) will be drawn for routine tests. - If you can become pregnant, part of the above routine blood sample or urine will be collected for a pregnancy test. At the end of Cycle 8 and then every 4 cycles after that (Cycles 12, 16, 20, and so on), you will have an MRI or CT scan. Length of Study: You may continue taking the study drugs for up to 24 months or 35 doses, whichever is later. 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. End-of-Treatment Visit: - Blood (about 4 teaspoons) will be drawn for routine testing and to learn how the study drug has affected the disease. - You will have an MRI or CT scan. - If you stop treatment because the disease got worse, you may have 4 core needle tumor biopsies. - If you can become pregnant, part of the above routine blood sample or urine will be collected for a pregnancy test. Follow-Up: If you stopped taking the study drug for any reason other than the disease getting worse, you will have an MRI or CT scan every 12 weeks. If the disease appears to get worse during this time, you may be eligible to be re-treated with pembrolizumab for an additional year (described below). Re-Treatment: If the disease got worse during follow-up and you are still eligible, you may be able to receive up to 1 year of additional treatment with pembrolizumab. If you continue to receive pembrolizumab, you will receive it at the same dose and schedule as described above. You will also continue to have study visits as described above. Safety Follow-Up Visit: About 30 days after your last dose of study drugs or before you start a new anti-cancer treatment (whichever happens first), you will have a safety follow-up visit. At this visit, you will have a physical exam and blood (about 2½ teaspoons) will be drawn for routine tests. This may mean that you have 2 safety follow-up visits if you receive an additional year of pembrolizumab. Long-Term Follow-Up: After follow-up, you will be called every 12 weeks by a member of the study staff to learn how you are doing. This call should last about 5 minutes. ;
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