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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 (CheckMate 744)

  • Clinicaltrials.gov identifier

    NCT02927769

  • Recruitment Status

    Active, not recruiting

  • First Posted

    October 7, 2016

  • Last update posted

    July 22, 2022

Study Description

Brief summary:

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.

  • Condition or Disease:Hodgkin Disease
  • Intervention/Treatment: Biological: Nivolumab
    Biological: brentuximab vedotin
    Biological: bendamustine
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 72 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: March 2017
  • Estimated Primary Completion Date: January 2024
  • Estimated Study Completion Date: November 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Nivolumab + brentuximab vedotin
Biological: Nivolumab
Specified Dose on Specified Days

Biological: brentuximab vedotin
Specified Dose on Specified Days
Experimental: brentuximab vedotin + bendamustine
Biological: brentuximab vedotin
Specified Dose on Specified Days

Biological: bendamustine
Specified Dose on Specified Days

Outcome Measures

  • Primary Outcome Measures: 1. Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
    Low Risk Group. Based on blinded independent central review (BICR)
  • 2. Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [ Time Frame: Up to 5 years ]
    Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on the blinded independent central review (BICR) using Lugano 2014 criteria.
  • 3. Complete Metabolic Response (CMR) rate at any time prior to radiation therapy [ Time Frame: Up to 5 years ]
    Low Risk Group. The CMR rate is defined as the proportion of all response-evaluable participants who, assessed by the BICR, achieve best response of CMR using Lugano 2014 criteria.
  • Secondary Outcome Measures: 1. Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment [ Time Frame: Up to 12 weeks ]
    Based on blinded independent central review (BICR)
  • 2. Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
    Based on the blinded independent central review (BICR)
  • 3. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Based on the blinded independent central review (BICR)
  • 4. Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
    measured by number of patients
  • 5. Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
    Hematology, Chemistry and Urinalysis
  • 6. Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. [ Time Frame: Up to 5 years ]
    Temperature, Blood Pressure and Heart Rate
  • 7. Complete Metabolic Response (CMR) rate prior to HDCT/ASCT [ Time Frame: Up to 5 years ]
    Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on investigator assessments using Lugano 2014 criteria.
  • 8. Complete Metabolic Response (CMR) rate at any time prior to radiation therapy [ Time Frame: Up to 5 years ]
    Low Risk Group. This is the rate prior to radiation therapy based on investigator assessments using Lugano 2014 criteria.
  • 9. Event Free Survival (EFS) [ Time Frame: Up to 5 years ]
    Low Risk Group. Based on investigator assessments
  • 10. Overall Response Rate (ORR) after 4 cycles of nivolumab + brentuximab vedotin treatment [ Time Frame: Up to 12 weeks ]
    Both Risk Groups. Based on investigator assessments
  • 11. Progression Free Survival Rate (PFSR) [ Time Frame: Up to 5 years ]
    Both Risk Groups. Based on investigator assessments
  • 12. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Both Risk Groups. Based on investigator assessments

Eligibility Criteria

  • Ages Eligible for Study: 5 to 30 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: 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. One prior anti-cancer therapy that did not work Exclusion Criteria: Active, known, or suspected autoimmune disease or infection Active cerebral/meningeal disease related to the underlying malignancy More than one line of anti-cancer therapy or no treatment at all Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Locations

United States, Alabama
Children's Hospital of Alabama
Birmingham

United States, Arizona
Phoenix Children'S Hospital
Phoenix

United States, California
Loma Linda University Cancer Center
Loma Linda

United States, California
Southern California Permanente Medical Group
Los Angeles

United States, California
Valley Children's Hospital
Madera

United States, California
Children'S Hospital & Research Center At Oakland
Oakland

United States, California
Children'S Hospital Of Orange County
Orange

United States, California
Lucile Packard Children'S Research Hospital/Stanford Univ
Palo Alto

United States, Colorado
Childrens Hospital of Colorado
Aurora

United States, Connecticut
Smilow Cancer Hospital At Yale New Haven Hospital
New Haven

United States, Delaware
Nemours / A. I. duPont Hospital for Children
Wilmington

United States, District of Columbia
Children'S National Medical Center
Washington

United States, Florida
Nemours Children'S Clinic
Jacksonville

United States, Florida
Local Institution - 0069
Saint Petersburg

United States, Georgia
Children's Healthcare Of Atlanta
Atlanta

United States, Iowa
University Of Iowa
Iowa City

United States, Maryland
John Hopkins University
Baltimore

United States, Massachusetts
Dana Farber Cancer Institute.
Boston

United States, Mississippi
University Of Mississippi Medical Center
Jackson

United States, Missouri
Children'S Mercy Hospital And Clinics
Kansas City

United States, Missouri
Washington University School Of Medicine
Saint Louis

United States, Nevada
Nevada Cancer Research Foundation
Las Vegas

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick

United States, New York
Roswell Park Cancer Institute
Buffalo

United States, North Carolina
Local Institution
Chapel Hill

United States, North Carolina
Carolinas Medical Center
Charlotte

United States, Ohio
Cincinnati Children'S Hospital Medical Center
Cincinnati

United States, Ohio
Nationwide Children'S Hospital
Columbus

United States, Oklahoma
University Of Oklahoma Health Sciences Center
Oklahoma City

United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey

United States, Pennsylvania
Childrens Hospital Of Philadelphia
Philadelphia

United States, Pennsylvania
Childrens Hospital Of Pittsburgh Of Upmc
Pittsburgh

United States, Tennessee
Vanderbilt University
Nashville

United States, Texas
Dell Children'S Medical Center Of Central Texas
Austin

United States, Texas
Local Institution - 0071
Dallas

United States, Texas
Baylor College Of Medicine
Houston

United States, Utah
Primary Children's Hospital
Salt Lake City

United States, Virginia
Children'S Hosp-Kings Daughter
Norfolk

United States, Virginia
Virginia Commonwealth University
Richmond

United States, Washington
Seattle Childrens Hospital
Seattle

United States, Wisconsin
Children'S Hospital Of Wisconsin
Milwaukee

Canada, Alberta
Local Institution
Calgary

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
The Montreal Children's Hospital of the MUHC
Montreal

Czechia
Klinika detske hematologie a onkologie
Praha 5

France
Hôpital Jeanne de Flandre
Lille

France
CHU Lyon GH Est
Lyon Cedex 08

France
Hopital De La Timone
Marseille Cedex 5

France
Local Institution
Nantes

France
Hopital Enfants Armand Trousseau
Paris

France
Hopital Robert Debre
Paris

France
CHU de Toulouse - Hopital des Enfants
Toulouse cedex 9

France
CHRU Nancy - Hopital Brabois Enfant
Vandoeuvre les Nancy

France
Institut Gustave Roussy
Villejuif Cedex

Germany
Local Institution - 0056
Berlin

Germany
Uniklinikum Giessen und Marburg
Giessen

Germany
Mhh Kinderklinik
Hannover

Germany
Local Institution - 0102
Muenchen

Ireland
Local Institution
Dublin

Italy
Cro-Aviano
Aviano (PN)

Italy
Local Institution - 0020
Bologna

Italy
Irccs Istituto G. Gaslini
Genova

Italy
Local Institution - 0019
Monza (mb)

Italy
Ao Santobono - Pausilipon
Napoli

Italy
AOU Policlinico Umberto I
Roma

Netherlands
Local Institution
Rotterdam

Netherlands
Local Institution
Utrecht

Poland
Local Institution
Gdansk

Poland
Local Institution
Krakow

Spain
Local Institution
Esplugues de Llobregat

Spain
Local Institution
Madrid

United Kingdom, Greater London
Local Institution
London

United Kingdom, North Yorkshire
Local Institution
Leeds

United Kingdom, Yorkshire
Local Institution
Leeds

United Kingdom
Local Institution
Birmingham

United Kingdom
Local Institution
Glasgow

United Kingdom
Local Institution
Manchester

Sponsors and Collaborators

Bristol-Myers Squibb

Seagen Inc.

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT02927769 History of Changes
  • Other Study ID Numbers: CA209-744, 2016-002347-41
  • First Posted: October 7, 2016 Key Record Dates
  • Last Update Posted: July 22, 2022
  • Last Verified: July 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Hodgkin Disease
    Lymphoma
    Neoplasms by Histologic Type
    Neoplasms
    Lymphoproliferative Disorders
    Lymphatic Diseases
    Immunoproliferative Disorders
    Immune System Diseases