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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

CheckMate 744 Trial 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.Check my eligibility

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.See study design

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.

CheckMate 744 Trial 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.

Select...

I have had one cancer treatment that was not effective.

CheckMate 744 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

CheckMate 744 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

~4750

brentuximab vedotin

2010

Completed Phase 3

~1880

bendamustine

2012

Completed Phase 4

~1440

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,442 Total Patients Enrolled

Seagen Inc.Industry Sponsor

207 Previous Clinical Trials

69,085 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

Frequently Asked Questions

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

What are some similar studies that have been done using Nivolumab?

"Nivolumab is currently being researched in 873 different clinical trials, 109 of which are in the third stage. Many of these trials originate from Basel, BE; however, there are a total of 46121 locations running Nivolumab studies."

Answered by AI

How many test subjects are being used for this research?

"This particular clinical trial is no longer actively recruiting patients. The listing for this study was first posted on March 28th, 2017 and updated for the last time on November 4th, 2022. If you are interested in other trials, please note that there are currently 188 active listings for hodgkin disease and 873 active listings for Nivolumab."

Answered by AI

How can I become involved in this research project?

"This trial is searching for 72 individuals between the ages of 5 and 30 that have hodgkin disease. Other requirements for participants include: relapsed or refractory Classic Hodgkin Lymphoma (cHL), able to perform most activities of daily living, and one prior failed anti-cancer therapy."

Answered by AI

In how many diverse locations is this study being conducted?

"Patients are currently being enrolled at John Hopkins University, The University Of Texas, and Local Institution - 0048. There are also 65 other potential sites for this clinical trial."

Answered by AI

Are there any life-threatening dangers associated with Nivolumab?

"Nivolumab's efficacy is unknown, however it received a score of 2 due to the fact that there is some data supporting its safety from Phase 2 trials."

Answered by AI

What are some common conditions that Nivolumab helps to improve?

"Nivolumab is typically used to treat melanoma that cannot be surgically removed. Additionally, this immunotherapy drug can also help patients with high-risk squamous cell carcinoma and those who have relapsed."

Answered by AI

Does this research project permit elderly patients to enroll?

"According to the clinical trial's inclusion criteria, patients must be aged 5-30. Out of the 2331 total trials, 133 are for people under 18 and 1002 are for senior citizens."

Answered by AI

Are new participants being accepted for this research project?

"No. The most recent information available on clinicaltrials.gov reveals that this trial has not been recruiting patients since November 4th, 2020. However, there are 1061 other trials which are still looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment

2017. "A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Relapsed or Refractory From First Line Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02927769.

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