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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

    Recruiting

  • First Posted

    October 7, 2016

  • Last update posted

    June 11, 2020

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
  • Estimated Enrollment: 80 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)
  • Actual Study Start Date: March 2017
  • Estimated Primary Completion Date: March 2023
  • Estimated Study Completion Date: March 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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 could apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT# and Site #.

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
Local Institution
Los Angeles

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
Local Institution
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, California
Local Institution
Roseville

United States, California
Local Institution
San Francisco

United States, California
Local Institution
Santa Clara

United States, Colorado
Childrens Hospital of Colorado
Aurora

United States, Connecticut
Local Institution
Hartford

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
All Children'S Hospital
Saint Petersburg

United States, Georgia
Children's Healthcare Of Atlanta
Atlanta

United States, Illinois
Local Institution
Chicago

United States, Indiana
Indiana University - Riley Children'S Hospital
Indianapolis

United States, Iowa
University Of Iowa
Iowa City

United States, Kentucky
Local Institution
Louisville

United States, Maryland
John Hopkins University
Baltimore

United States, Massachusetts
Dana Farber Cancer Institute.
Boston

United States, Michigan
Local Institution
Ann Arbor

United States, Michigan
Local Institution
Detroit

United States, Michigan
Local Institution
Grand Rapids

United States, Minnesota
Local Institution
Minneapolis

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, New York
Local Institution
New Hyde Park

United States, New York
Local Institution
New York

United States, New York
Local Institution
New York

United States, New York
Local Institution
Valhalla

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, Oregon
Local Institution
Portland

United States, Pennsylvania
Penn State Hershey Children'S Hospital
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
The University Of Texas
Dallas

United States, Texas
Local Institution
Fort Worth

United States, Texas
Baylor College Of Medicine
Houston

United States, Texas
Local Institution
San Antonio

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

United States, Virginia
Local Institution
Fairfax

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, Ontario
Local Institution
Toronto

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

Canada
Local Institution
Calgary

Czechia
Klinika detske hematologie a onkologie
Praha 5

France
Local Institution
Lille cedex

France
CHU Lyon GH Est
Lyon Cedex 08

France
Local Institution
Marseille Cedex 5

France
CHU de Nantes - Hopital Mere-enfant
Nantes

France
Local Institution
Paris Cedex 12

France
Hopital Robert Debre
Paris

France
Local Institution
Toulouse cedex 9

France
Local Institution
Vandoeuvre les Nancy

France
Local Institution
Villejuif Cedex

Germany
Campus Virchow Klinikum Der Charite
Berlin

Germany
Uniklinikum Giessen und Marburg
Giessen

Germany
Mhh Kinderklinik
Hannover

Germany
Dr. von Haunersches Kinderspital
Muenchen

Ireland
Local Institution
Dublin

Italy
Cro-Aviano
Aviano (PN)

Italy
Policlinico S. Orsola Malpighi
Bologna

Italy
Irccs Istituto G. Gaslini
Genova

Italy
Fondazione Monza e Brianza per il Bambino e la sua Mamma MBBM
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

Poland
Local Institution
Poznan

Poland
Local Institution
Warszawa

Spain
Local Institution
Esplugues de Llobregat

Spain
Local Institution
Madrid

Spain
Local Institution
Sevilla

Spain
Local Institution
Valencia

United Kingdom, Greater London
Local Institution
London

United Kingdom, North Yorkshire
Local Institution
Leeds

United Kingdom, WEST Yorkshire
Local Institution
Leeds

United Kingdom, Yorkshire
Local Institution
Leeds

United Kingdom
Local Institution
Birmingham

United Kingdom
Local Institution
Glasgow

United Kingdom
Local Institution
Glasgow

United Kingdom
Local Institution
Manchester

United Kingdom
Local Institution
Nottingham

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: June 11, 2020
  • Last Verified: June 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Hodgkin Disease