Expired Study
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Houston, Texas 77030


Purpose:

The goal of this clinical research study is to learn if nivolumab can help to control MF. The safety of this drug will also be studied.


Study summary:

Study Drug Administration: If you are found to be eligible to take part in this study, you will receive nivolumab by vein over 60 minutes, every 2 weeks (+/- 2 days). After 8 doses (4 cycles), nivolumab will be given once every 12 weeks after that. Study Visits: Each cycle is 28 days. On Days 1, 7, and 14 of Cycle 1; Days 1 and 14 of Cycles 2-4; Day 1 of Cycle 5 and then Day 1 of every third cycle after that (Cycles 8, 11, 14, and so on): - You will have a physical exam. - Blood (about 1-2 teaspoons each time) will be drawn for routine tests. Some of these blood samples may also be used for tests of your pancreatic function and blood sugar levels. - You will complete the questionnaire about your quality of life. Before each dose of the study drug, blood (about 2 tablespoons) will be drawn to check your immune system. On Day 1 of Cycles 3 and 5, and then every 3 cycles after that (Cycles 8, 11, 14 and so on), blood (about 1-2 teaspoons) will be drawn for a pregnancy test, if you can become pregnant On Day 1 of Cycle 5, and then every 3 cycles after that (Cycles 8, 11, 14, and so on) if the doctor thinks it is needed, you will have a bone marrow biopsy to check the status of the disease and for cytogenetic and genetic testing. Length of Treatment: You may continue taking the study drug for up to 4 years. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up. End-of-Treatment Visit: After you are finished receiving the study drug, blood (about 2 tablespoons) will be drawn to check your immune system. Follow-Up: About 30, 60, and 100 days after your last dose of the study drug, if you are not receiving another treatment for MF, a member of the study staff will call you to ask about any side effects you may be having. This call should last about 10 minutes. If you can become pregnant, you will need to return to the clinic about 30 and 100 days after your last dose of the study drug for a pregnancy test. This is an investigational study. Nivolumab is FDA-approved and commercially available for the treatment of certain kinds of melanoma. Nivolumab is not FDA approved or commercially available for the treatment of MF. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.


Criteria:

Inclusion Criteria: 1. Diagnosis of MF (either primary or post essential thrombocythemia/polycythemia vera) requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate-1 or -2 or high risk according to International Prognostic Scoring System (IPSS). 2. Previously treated with ruxolitinib (unless not a good candidate for ruxolitinib therapy in the judgment of treating physician) 3. Palpable splenomegaly or hepatomegaly of more than or equal to 5 cm below left or right, respectively, costal margin on physical exam 4. Understanding and voluntary signing an IRB-approved informed consent form. 5. No prior history of immune checkpoint modulator therapy 6. Age 18 years or older at the time of signing the informed consent. 7. Disease-free of other malignancies. 8. ECOG performance status 0 to 2. 9. Negative pregnancy test in females of childbearing potential (FCBP). Male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 23 weeks (for females) or 31 weeks (for males) following the last dose of study medication. Acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner's vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap plus spermicide. Female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test within 24 hours of the first study treatment. 10. Adequate organ function as demonstrated by the following: Direct bilirubin equal to or less than 1.5 x upper limit of normal (ULN), Serum creatinine equal to or less than 1.5 x ULN, AST (SGOT) and ALT (SGPT) equal to or less than 2.5 x ULN (unless considered to be related to MF or patient has known history of Gilberts, in which case it must be equal to or less than 5 x ULN) Exclusion Criteria: 1. Use of any other standard or experimental therapy within 14 days of starting study therapy. 2. Lack of recovery from all toxicity from previous therapy to grade 1 or baseline. 3. Any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities. 4. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association Class III-IV within 6 months prior to their first dose of the study drugs 5. Patients who are currently receiving chronic (>14 days) treatment with corticosteroids at a dose equal to or more than 10 mg of prednisone (or its glucocorticoid equivalent) per day, or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug 6. Patients with autoimmune diseases are excluded: Patients with a history of Inflammatory Bowel Disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis 7. Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive beta-HCG laboratory test. 8. Known positive for HIV or infectious hepatitis, type A, B or C. 9. The use of dietary supplements or herbal medications within 7 days of starting study therapy.


NCT ID:

NCT02421354


Primary Contact:

Principal Investigator
Srdan Verstovsek, MD
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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