NCT03075553

Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Phase 2 Single-Arm, Open-Label Study of Nivolumab in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mayo Clinic · 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 peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.

Detailed description

PRIMARY OBJECTIVES: I. To assess the clinical benefit of nivolumab in T-cell lymphomas, as measured by objective response rate (ORR) within 12 cycles according to the Lugano Classification Response Criteria (2014). SECONDARY OBJECTIVES: I. To assess safety and tolerability of the regimen in this patient population. II. To assess progression-free survival (PFS). III. To assess duration of response (DOR). IV. To assess overall survival (OS). TERTIARY OBJECTIVES: I. To evaluate T-cell/cytokine profile in the peripheral blood - peripheral blood specimens will be used to assess T-cell activation and cytokine up regulation as measures of treatment effect. II. To evaluate intratumoral biomarkers- intratumoral cell populations and distribution, genetic variability, mutational burden and T-cell activation will be evaluated to identify potential biomarkers that correlate with response to therapy. III. To assess the potential association between PD-L1/PD-1/PD-L2 expression on tumor and T-cells and/or PD-L1 soluble levels in plasma with clinical efficacy of PD-1 blockade. OUTLINE: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive nivolumab IV over 60 minutes on day 1 of course 9. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 35 days, 100-120 days, 230-250 days, and 330-390 days.

Conditions

• Blastic Plasmacytoid Dendritic Cell Neoplasm
• Hepatosplenic T-Cell Lymphoma
• HTLV-1 Infection
• NK-Cell Lymphoma, Unclassifiable
• Primary Systemic Anaplastic Large Cell Lymphoma, ALK-Negative
• Recurrent Adult T-Cell Leukemia/Lymphoma
• Recurrent Anaplastic Large Cell Lymphoma
• Recurrent Angioimmunoblastic T-cell Lymphoma
• Recurrent Enteropathy-Associated T-Cell Lymphoma
• Recurrent Mycosis Fungoides
• Refractory Adult T-Cell Leukemia/Lymphoma
• Refractory Anaplastic Large Cell Lymphoma
• Refractory Angioimmunoblastic T-cell Lymphoma
• Refractory Enteropathy-Associated T-Cell Lymphoma
• Refractory Mycosis Fungoides
• Refractory Nasal Type Extranodal NK/T-Cell Lymphoma
• Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2017-05-17
• Primary completion: 2019-05-29
• Completion: 2019-05-29
• First posted: 2017-03-09
• Last updated: 2020-04-21
• Results posted: 2020-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study