NCT02421354

Nivolumab in Treating Patients With Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, or Post-Polycythemia Vera Myelofibrosis

Phase 2 Study of Nivolumab in Patients With Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, or Post-Polycythemia Vera Myelofibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatomegaly
• Myelofibrosis Transformation in Essential Thrombocythemia
• Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
• Primary Myelofibrosis
• Splenomegaly

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Nivolumab	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2015-05-14
• Primary completion: 2018-04-13
• Completion: 2018-04-13
• First posted: 2015-04-20
• Last updated: 2019-05-15
• Results posted: 2019-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study