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Trial record 1 of 1 for:    nivolumab and mf
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Study of Nivolumab in Patients With Myelofibrosis

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02421354
First received: April 10, 2015
Last updated: January 5, 2017
Last verified: January 2017
  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.

Condition Intervention Phase
Myeloproliferative Diseases Drug: Nivolumab Behavioral: Questionnaire Behavioral: Phone Call Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: May 2015
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02421354

Contacts
Contact: Srdan Verstovsek, MD 713-792-7305

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02421354     History of Changes
Other Study ID Numbers: 2014-0962
NCI-2015-00836 ( Registry Identifier: NCI CTRP )
Study First Received: April 10, 2015
Last Updated: January 5, 2017

Keywords provided by M.D. Anderson Cancer Center:
Myeloproliferative Diseases
Post-Essential Thrombocythemia Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
MF
Nivolumab
BMS-936558
Questionnaire
Survey
Phone call

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

ClinicalTrials.gov processed this record on June 23, 2017