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Clinical Trial Summary

This phase II trial studies how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as varlilumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the anti-tumor activity of combination therapy with CDX-1127 (varlilumab) and nivolumab as compared to nivolumab alone in patients with advanced aggressive B-cell non-Hodgkin lymphomas (NHL) based on the lymphoma response to immunomodulatory therapy criteria or LYRIC. SECONDARY OBJECTIVES: I. To assess the safety and tolerability profile of treatment with a combination of CDX-1127 (varlilumab) and nivolumab in patients with advanced aggressive B-cell NHL. II. To evaluate the duration of response, progression-free survival and overall survival. EXPLORATORY OBJECTIVES: I. To determine the effect of combination therapy with CDX-1127 (varlilumab) and nivolumab on the immune system as assessed by immunohistochemistry (IHC), mass cytometry (CyTOF), changes in serum cytokine profile and immunogenicity assays. II. To describe the pharmacokinetic profile of CDX-1127 (varlilumab) and nivolumab when used in combination. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive nivolumab intravenously (IV) over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression. GROUP II: Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 100 days. ;


Study Design


Related Conditions & MeSH terms

  • ALK-Positive Large B-Cell Lymphoma
  • Burkitt Lymphoma
  • Diffuse Large B-Cell Lymphoma Activated B-Cell Type
  • Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
  • Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • EBV-Positive Mucocutaneous Ulcer
  • HHV8-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Inflammation
  • Intravascular Large B-Cell Lymphoma
  • Large B-Cell Lymphoma With IRF4 Rearrangement
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Plasmablastic Lymphoma
  • Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
  • Primary Effusion Lymphoma
  • Recurrence
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Burkitt Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Recurrent Lymphomatoid Granulomatosis
  • Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
  • Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Burkitt Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Refractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
  • Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

NCT number NCT03038672
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 21, 2018
Completion date October 25, 2024

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