Nivolumab +/− Varlilumab for Lymphoma

Recruiting in Palo Alto (17 mi)

+37 other locations

Overseen byStephen M Ansell

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

+12 more

Exclusion Criteria

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

I still have side effects from treatment over 4 weeks ago.

I do not have any unmanaged ongoing illnesses.

+15 more

Participant Groups

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.

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.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: