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.|
|ClinicalTrials.gov Identifier: NCT02421354|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2015
Last Update Posted : November 14, 2017
|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)|
|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|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
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.
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-936558Behavioral: 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: SurveyBehavioral: 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02421354
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Srdan Verstovsek, MD||M.D. Anderson Cancer Center|