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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate

Secondary outcome measures

Duration of response

Incidence of adverse events

Progression free survival (PFS)

+1 more

Other outcome measures

Body Weight Changes

Chromosomes

Body tissue

+3 more

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

2014

Completed Phase 3

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,319 Total Patients Enrolled

1,387 Trials studying Lymphoma

382,517 Patients Enrolled for Lymphoma

Stephen M AnsellPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO

1 Previous Clinical Trials

62 Total Patients Enrolled

1 Trials studying Lymphoma

62 Patients Enrolled for Lymphoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03038672 — Phase 2

Lymphoma Research Study Groups: Group I (nivolumab), Group II (varlilumab, nivolumab)

Lymphoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03038672 — Phase 2

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03038672 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation enrolling participants at the present time?

"Data hosted on clinicaltrials.gov affirms that enlistment for this trial has ceased; the listing was first posted on November 30th 2017 and last updated August 26th 2022. Nonetheless, there are over 3700 other trials currently looking to accompany patients in their research efforts."

Answered by AI

How many healthcare facilities have been selected to host this investigation?

"This medical trial has been set up in Moffitt Cancer Center - McKinley Campus in Tampa, Florida, University of Kansas Cancer Center at North Kansas City Hospital in North Kansas City, Missouri and Dartmouth Hitchcock Medical Center in Lebanon, New hampshire as well as an additional 27 locations."

Answered by AI

What prior experiments have been completed with Varlilumab?

"Currently, there are 724 live clinical trials researching Varlilumab with 82 of these in their final Phase 3. While Zürich, BE holds a significant portion of the studies for this drug, over 40 thousand locations around the world are currently engaged in its investigation."

Answered by AI

To what maladies is varlilumab generally administered?

"Varlilumab is the go-to therapy for malignant neoplasms, and it has also been seen to be efficacious in treating other illnesses including unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Is this a pioneering research effort?

"The exploration of Varlilumab began in 2012, when Ono Pharmaceutical Co. Ltd sponsored a clinical trial with 659 participants. Subsequent Phase 1 & 2 approvals catalyzed the current state wherein 724 trials are underway across 2356 cities and 49 nations worldwide."

Answered by AI

Has the FDA issued a green light for Varlilumab?

"Our team at Power assigned Varlilumab a safety score of 2, as there is data that suggests it is safe for use but no evidence yet demonstrating its efficacy."

Answered by AI

How many individuals are the subject of this clinical investigation?

"Unfortunately, this research program is not currently accepting participants. Initially posted on November 30th 2017 and last edited August 26th 2022, you may want to look into the 3045 studies actively enrolling patients with diffuse lymphoma or 724 trials utilising Varlilumab in their interventions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03038672.

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