Primary Myelofibrosis Clinical Trial
Official title:
Phase 2 Study of Nivolumab in Patients With Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, or Post-Polycythemia Vera Myelofibrosis
This phase II trial studies how well nivolumab works in treating patients with primary myelofibrosis, post-essential thrombocythemia myelofibrosis, or post-polycythemia vera myelofibrosis. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES:
I. To determine the efficacy/clinical activity of nivolumab in patients with myelofibrosis
(MF).
SECONDARY OBJECTIVES:
I. To determine the safety of nivolumab in patients with MF.
TERTIARY OBJECTIVES:
I. To explore time to response and duration of response. II. To assess changes in symptom
burden. III. To explore changes in bone marrow fibrosis. IV. To explore changes in Janus
kinase 2 valine at amino acid position 617 (JAK2V617F) (or other molecular marker) allele
burden or changes in cytogenetic abnormalities.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 60 minutes once every 2 weeks for 8 doses
and then once every 12 weeks thereafter. Treatment may continue for up to 4 years in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30, 60, and 100 days.
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