Phase II study of MK-3475 in conjunction with lymphodepletion, TIL, and high or low dose IL-2 in patients with metastatic melanoma

The goal of this clinical research study is to learn if pembrolizumab, an infusion of T-cells, chemotherapy (cyclophosphamide and fludarabine), and either high or low dose interleukin-2 (IL-2) can help to control metastatic melanoma. The safety of this drug combination will also be studied. T-cells are white blood cells in your body that are important to the immune system. The T-cells used in this study will be collected and grown in a separate study (MD Anderson Protocol 2004-0069) Screening Tests Signing this consent form does not mean that you will be able to take part in this study. You will have screening tests to help the doctor decide if you are eligible. You will have a physical exam. You will have an electrocardiogram (EKG) to check your heart function. Blood (about 4 tablespoons) and urine will be collected for routine tests and to check for hepatitis B and C, HIV (the AIDS virus), and other types of infections. This routine urine or blood collection will also include a pregnancy test, if you can become pregnant. To take part in this study, you must not be pregnant. Blood (about 2 teaspoons) will be drawn to test for an infection called cytomegalovirus (CMV). You will have tests to check your lung function. You will have a cardiac stress test to check your heart function. For this test, you will either exercise on a treadmill or receive a drug that makes your heart beat faster (such as dopamine hydrochloride) while the study staff checks your heart rate with a heart monitor. The doctor will describe the cardiac stress test to you in more detail. You will fill out 2 questionnaires about your quality of life. This should take about 10 minutes total to complete. You will have either an excisional or core tumor biopsy to check the status of the disease. To perform an excisional biopsy, the affected area is completely removed by cutting it out. To perform a core biopsy, a sample of tissue is removed using a hollow core needle that has a cutting edge. The study doctor will tell you which type of biopsy you will have and you will sign a separate consent form explaining the procedure and its risks in more detail. Blood (about 3 tablespoons) will be drawn to study your immune system. Within 30 days before your first dose of study drugs, you will have a computed tomography (CT) or positron emission tomography (PET)/CT scan of the chest, abdomen, and pelvis to check the status of the disease. You will also have a CT of the neck, if the doctor thinks it is needed. If you have not had 1 in the last 30 days, you will have magnetic resonance imaging (MRI) or a CT scan of the brain to check the status of the disease. If you the doctor thinks it is needed, you will have photographs taken of any skin lesions by a medical photographer. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face. The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other options will be discussed with you..

Disease Group: Melanoma

Treatment Agent: Interleukin-2,MK-3475

Treatment Location: Only at MDACC

Sponsor: Merck,Prometheus

IRB Review and Approval Date: 08/07/2015

Recruitment Status: Open

Projected Accrual: N/A

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT02500576