Nivolumab + Brentuximab Vedotin for Hodgkin's Lymphoma

(CheckMate 744 Trial)

Recruiting at144 trial locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

My Hodgkin Lymphoma has returned or is not responding to treatment.

I can do most of my daily activities on my own.

I have had one cancer treatment that was not effective.

Exclusion Criteria

I have been treated with drugs that boost the immune system's response to cancer.

I have had more than one cancer treatment or none at all.

I have had a stem cell or solid organ transplant for Hodgkin Lymphoma.

Treatment Details

Interventions

• Bendamustine (Alkylating agents)
• Brentuximab Vedotin (Monoclonal Antibodies)
• Nivolumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: brentuximab vedotin + bendamustine Experimental Treatment 2 Interventions

Group II: Nivolumab + brentuximab vedotin Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Seagen Inc.

Industry Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University