NCT02927769
Active, not recruiting
October 7, 2016
July 22, 2022
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.
N/A
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 |
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
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
Bristol-Myers Squibb
Seagen Inc.
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb