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Checkpoint Inhibitor

Nivolumab +/− Varlilumab for Lymphoma

Phase 2

Waitlist Available

Led By Stephen M Ansell

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a histopathologically confirmed diagnosis of an aggressive B-cell non-Hodgkin lymphoma that is recurrent or refractory to standard therapy

Diagnoses must fall under Category A or Category B as per the 2016 revision of the World Health Organization (WHO) classification of lymphoid neoplasms

Must not have

Received chemotherapy, targeted agent, or radiotherapy within 4 weeks prior to registration

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nivolumab with or without varlilumab to see how well it works in treating patients with aggressive B-cell lymphomas.

Who is the study for?

This trial is for adults with aggressive B-cell non-Hodgkin lymphoma that has returned or resisted treatment after two standard therapies. Participants must have a life expectancy over 12 weeks, measurable disease, good physical function (ECOG 0-1), and adequate blood counts and organ function. Pregnant or breastfeeding women, those with severe allergies to similar drugs, uncontrolled illnesses, certain autoimmune diseases, recent immunosuppressants use or other cancers being treated within the last three years are excluded.

What is being tested?

The study is testing how well nivolumab works alone or combined with varlilumab in treating recurrent or refractory aggressive B-cell lymphomas. These medications are types of immunotherapy called monoclonal antibodies which may boost the immune system's ability to fight cancer and stop tumor growth.

What are the potential side effects?

Potential side effects include allergic reactions to the medication components; symptoms related to immune system activation such as fatigue, skin issues, inflammation of organs; possible interference with normal organ functions; and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My aggressive B-cell lymphoma has come back or didn't respond to treatment.

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My lymphoma diagnosis fits into Category A or B of the WHO's 2016 classification.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My condition did not improve after two standard treatments.

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My kidneys are functioning well.

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I have a tumor larger than 15 mm.

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I am of childbearing age and my pregnancy test is negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had chemotherapy, targeted therapy, or radiation in the last 4 weeks.

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I do not have any unmanaged ongoing illnesses.

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I have been treated with specific immune-targeting drugs before.

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I have an active stomach or intestine problem like diverticulitis or a blockage.

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I am allergic to medications similar to varlilumab or nivolumab.

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I have not needed treatment for another cancer within the last 3 years.

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I have or had an autoimmune disease that could come back.

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I am on steroids or immunosuppressants for my condition.

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I had a stem cell transplant using my own cells less than 12 weeks ago.

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I have active disease in my brain or spinal cord.

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I have hepatitis B but no significant liver damage or it's undetectable with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate

Secondary study objectives

Duration of Response

Overall Survival

Progression Free Survival (PFS)

+1 more

Other study objectives

Change in CD27 Expression in Tissue

Change in Genetic Alterations of Chromosome 9p24.1 in Tissue

Change in Mutation Burden in Tissue

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (varlilumab, nivolumab)Experimental Treatment2 Interventions

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.

Group II: Group I (nivolumab)Active Control1 Intervention

Patients 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. Patients may cross over to Group II at the time of disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

0 / 18Eligibility criteria met