Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas

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.

Conditions

• ALK-Positive Large B-Cell 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
• Intravascular Large B-Cell Lymphoma
• Large B-Cell Lymphoma With 11q Aberration
• Large B-Cell Lymphoma With IRF4 Rearrangement
• Plasmablastic Lymphoma
• Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
• Primary Effusion Lymphoma
• Recurrent B-Cell Non-Hodgkin Lymphoma
• Recurrent Burkitt Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Gray-Zone 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 Primary Mediastinal Large B-Cell Lymphoma
• 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 Gray-Zone 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 Primary Mediastinal Large B-Cell Lymphoma
• Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

Interventions

BIOLOGICAL

Nivolumab

Given IV

DRUG

Varlilumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Stephen M Ansell · Dana-Farber - Harvard Cancer Center LAO

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-21

Primary Completion

2023-05-26

Completion

2026-10-24

FDA Drug

Yes

Countries

• United States

Study Locations