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Monoclonal Antibodies

Nivolumab + Brentuximab Vedotin for Hodgkin's Lymphoma (CheckMate 744 Trial)

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Classic Hodgkin Lymphoma (cHL), relapsed or refractory
Minimal limitation on activities of daily living as measured by Karnofsky ≥ 50 for participants > 16 years of age or Lansky ≥ 50 for participants ≤ 16 years of age.
Must not have
Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
More than one line of anti-cancer therapy or no treatment at all
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will test whether nivolumab plus brentuximab vedotin is safe and effective in treating patients with Hodgkin's lymphoma who have relapsed or are refractory to first line treatment.

Who is the study for?
This trial is for young patients aged 5-30 with Hodgkin's Lymphoma that has come back or didn't respond to first treatment. They should be mostly able to do daily activities and have had only one prior cancer therapy. Those who've had stem cell transplants, multiple treatments, or certain autoimmune diseases can't join.
What is being tested?
The study tests if Nivolumab combined with Brentuximab Vedotin is effective for treating Hodgkin's Lymphoma in youth. If the response isn't great, they'll add Bendamustine. It aims to find a safe and effective second-line treatment option.
What are the potential side effects?
Possible side effects include immune system reactions like inflammation of organs, infusion-related symptoms, fatigue, nausea, blood count changes which could increase infection risk. Each patient may experience these differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Hodgkin Lymphoma has returned or is not responding to treatment.
Select...
I can do most of my daily activities on my own.
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I have had one cancer treatment that was not effective.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with drugs that boost the immune system's response to cancer.
Select...
I have had more than one cancer treatment or none at all.
Select...
I have had a stem cell or solid organ transplant for Hodgkin Lymphoma.
Select...
I have an autoimmune disease or a current infection.
Select...
My cancer has spread to my brain or its coverings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Complete Metabolic Response (CMR) rate at any time prior to radiation therapy
Complete Metabolic Response (CMR) rate prior to HDCT/ASCT
Duration of Response (DOR)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: brentuximab vedotin + bendamustineExperimental Treatment2 Interventions
Group II: Nivolumab + brentuximab vedotinExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4740
brentuximab vedotin
2010
Completed Phase 3
~1880
bendamustine
2012
Completed Phase 4
~1440

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,652 Previous Clinical Trials
4,130,677 Total Patients Enrolled
Seagen Inc.Industry Sponsor
209 Previous Clinical Trials
74,303 Total Patients Enrolled

Media Library

Brentuximab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02927769 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Nivolumab + brentuximab vedotin, brentuximab vedotin + bendamustine
Hodgkin's Lymphoma Clinical Trial 2023: Brentuximab Vedotin Highlights & Side Effects. Trial Name: NCT02927769 — Phase 2
Brentuximab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02927769 — Phase 2
~9 spots leftby Sep 2025
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