Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
- ALK-Positive Large B-Cell Lymphoma
- Burkitt-Like Lymphoma With 11q Aberration
- Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
- Refractory Burkitt Lymphoma
- Diffuse Large B-Cell Lymphoma Activated B-Cell Type
- 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
- Recurrent Diffuse Large B-Cell Lymphoma
- Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
- Recurrent Burkitt Lymphoma
- Refractory B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
- Refractory B-Cell Non-Hodgkin Lymphoma
- Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Recurrent B-Cell Non-Hodgkin Lymphoma
- EBV-Positive Mucocutaneous Ulcer
- Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
- Refractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
- HHV8-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Intravascular Large B-Cell Lymphoma
- Recurrent Lymphomatoid Granulomatosis
- Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
- Refractory Diffuse Large B Cell Lymphoma
- Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Plasmablastic Lymphoma
- High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
- High Grade B-Cell Lymphoma, Not Otherwise Specified
- Large B-Cell Lymphoma With IRF4 Rearrangement
- Primary Effusion Lymphoma
- Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
- Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
- Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 LYR...
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.
Tracking Information
- NCT #
- NCT03038672
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Stephen M Ansell Dana-Farber - Harvard Cancer Center LAO
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