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Study of Nivolumab in Patients With Myelofibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02421354
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : April 24, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myeloproliferative Diseases Drug: Nivolumab Behavioral: Questionnaire Behavioral: Phone Call Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Nivolumab in Patients With Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, or Post-Polycythemia Vera Myelofibrosis
Actual Study Start Date : May 14, 2015
Actual Primary Completion Date : April 13, 2018
Actual Study Completion Date : April 13, 2018

Arm Intervention/treatment
Experimental: Nivolumab
Nivolumab 3 mg/kg given by vein every 2 weeks for 8 doses followed by a maintenance regimen of one dose every 12 weeks. Quality of life questionnaire routinely completed from baseline and thereafter.
Drug: Nivolumab
3 mg/kg given by vein approximately every 2 weeks for 8 doses followed by a maintenance regimen of one dose every 12 weeks.
Other Name: BMS-936558

Behavioral: Questionnaire
Questionnaire completed about participant's quality of life completed at baseline, Day 1, 7, 14 of Cycle 1, Days 1 and 14 of Cycles 2 - 5, and Day 1 of every third cycle after that. It should take about 10 minutes to complete each time.
Other Name: Survey

Behavioral: Phone Call
Study staff to call participant to ask about side effects about 30, 60, and 100 days after last dose of the study drug. This call should last about 10 minutes.

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 112 days ]
    ORR defined as CR (complete remission) + PR (partial remission) + CI (clinical improvement) after 8 doses of therapy. Responses categorized according to the revised International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeuekmiaNet (ELN) consensus criteria for myelofibrosis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02421354

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Srdan Verstovsek, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT02421354     History of Changes
Other Study ID Numbers: 2014-0962
NCI-2015-00836 ( Registry Identifier: NCI CTRP )
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Myeloproliferative Diseases
Post-Essential Thrombocythemia Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
Phone call

Additional relevant MeSH terms:
Primary Myelofibrosis
Polycythemia Vera
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs