NCT03770416

Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma

Nivolumab and Ibrutinib for Relapsed or Refractory Central Nervous System Lymphoma

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

Summary

This phase II trial studies the side effects and how well nivolumab and ibrutinib works in treating patients with central nervous system lymphoma that has come back or does not respond to treatment. 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. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and ibrutinib may work better in treating patients with central nervous system lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. Determine the overall response rate of nivolumab and ibrutinib in central nervous system (CNS) lymphoma. SECONDARY OBJECTIVES: I. Determine the overall response rate of 4 weeks of ibrutinib single agent in CNS lymphoma. II. Determine the complete response rate of nivolumab and ibrutinib in CNS lymphoma. III. Determine the 1-year progression free and overall survival outcomes in CNS lymphoma. IV. Safety and toxicity of nivolumab and ibrutinib. EXPLORATORY OBJECTIVES: I. Assess activation of T cells in peripheral blood and cerebrospinal fluid. II. Assess the cytokine profile from microglial cells in cerebrospinal fluid. III. Correlate features of peripheral blood T cell activation with toxicities. IV. Correlate features of peripheral blood T cell activation with response and progression free survival (PFS). V. Correlate baseline tumor characteristics with response and PFS. VI. Evaluate the ability of minimal residual disease testing to monitor response and differentiate from pseudo progression. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT A: Patients receive ibrutinib orally (PO) daily on days 1-28. Beginning course 1, patients also receive nivolumab intravenously (IV) over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. COHORT B: Patients receive ibrutinib PO daily on days 1-28 and nivolumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response after 6 courses may continue therapy for up to 2 years. After completion of study treatment, patients are followed up within 3-4 weeks and then every 3 months for 2 years.

Conditions

• Central Nervous System B-Cell Non-Hodgkin Lymphoma
• Recurrent Central Nervous System Lymphoma
• Refractory Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2019-02-15
• Primary completion: 2025-02-10
• Completion: 2025-02-10
• First posted: 2018-12-10
• Last updated: 2025-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study