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
NCT ID: NCT02927769
Last Updated: 2025-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2017-03-28
2024-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nivolumab + brentuximab vedotin
Nivolumab
Specified Dose on Specified Days
brentuximab vedotin
Specified Dose on Specified Days
brentuximab vedotin + bendamustine
brentuximab vedotin
Specified Dose on Specified Days
bendamustine
Specified Dose on Specified Days
Interventions
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Nivolumab
Specified Dose on Specified Days
brentuximab vedotin
Specified Dose on Specified Days
bendamustine
Specified Dose on Specified Days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
5 Years
30 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
Phoenix Children'S Hospital
Phoenix, Arizona, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
Valley Children's Hospital
Madera, California, United States
Children'S Hospital & Research Center At Oakland
Oakland, California, United States
Children'S Hospital Of Orange County
Orange, California, United States
Lucile Packard Children'S Research Hospital/Stanford Univ
Palo Alto, California, United States
Local Institution - 0091
San Diego, California, United States
Childrens Hospital of Colorado
Aurora, Colorado, United States
Smilow Cancer Hospital At Yale New Haven Hospital
New Haven, Connecticut, United States
Nemours / A. I. duPont Hospital for Children
Wilmington, Delaware, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Local Institution - 0062
Jacksonville, Florida, United States
Local Institution - 0069
St. Petersburg, Florida, United States
Children's Healthcare Of Atlanta
Atlanta, Georgia, United States
University Of Iowa
Iowa City, Iowa, United States
Local Institution - 0070
Baltimore, Maryland, United States
Dana Farber Cancer Institute.
Boston, Massachusetts, United States
Local Institution - 0097
Detroit, Michigan, United States
Local Institution - 0049
Jackson, Mississippi, United States
Local Institution - 0085
Kansas City, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Local Institution - 0067
Hackensack, New Jersey, United States
Local Institution - 0047
New Brunswick, New Jersey, United States
Local Institution - 0068
Buffalo, New York, United States
Local Institution
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Local Institution - 0089
Columbus, Ohio, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Local Institution - 0090
Hershey, Pennsylvania, United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Childrens Hospital Of Pittsburgh Of Upmc
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
Local Institution - 0042
Austin, Texas, United States
Local Institution - 0071
Dallas, Texas, United States
Baylor College Of Medicine
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children'S Hosp-Kings Daughter
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Local Institution - 0048
Seattle, Washington, United States
Local Institution - 0065
Milwaukee, Wisconsin, United States
Local Institution
Calgary, Alberta, Canada
Local Institution - 0092
Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada
Klinika detske hematologie a onkologie
Prague, , Czechia
Local Institution - 0034
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Local Institution - 0030
Lille, , France
Local Institution - 0029
Lyon, , France
Local Institution - 0032
Marseille, , France
Local Institution - 0028
Nantes, , France
Local Institution - 0031
Paris, , France
Local Institution - 0026
Paris, , France
Local Institution - 0033
Toulouse, , France
Local Institution - 0027
Villejuif, , France
Local Institution - 0056
Berlin, , Germany
Local Institution - 0055
Giessen, , Germany
Local Institution - 0057
Hanover, , Germany
Local Institution - 0102
München, , Germany
Local Institution - 0017
Dublin, , Ireland
Local Institution - 0024
Aviano (PN), , Italy
Local Institution - 0020
Bologna, , Italy
Local Institution - 0021
Genova, , Italy
Local Institution - 0019
Monza (mb), , Italy
Local Institution - 0023
Napoli, , Italy
Local Institution - 0022
Roma, , Italy
Local Institution - 0001
Rotterdam, , Netherlands
Local Institution - 0006
Utrecht, , Netherlands
Local Institution
Gdansk, , Poland
Local Institution
Krakow, , Poland
Local Institution - 0082
Barcelona, , Spain
Local Institution - 0084
Madrid, , Spain
Local Institution - 0035
Leeds, North Yorkshire, United Kingdom
Local Institution
Leeds, Yorkshire, United Kingdom
Local Institution
Birmingham, , United Kingdom
Local Institution
Glasgow, , United Kingdom
Local Institution - 0002
London, , United Kingdom
Local Institution - 0012
Manchester, , United Kingdom
Countries
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References
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Daw S, Cole PD, Hoppe BS, Hodgson D, Beishuizen A, Garnier N, Buffardi S, Mascarin M, Lissat A, Mauz-Korholz C, Krajewski J, Akyol A, Crowe R, Anderson B, Xu Y, Drachtman RA, Kelly KM, Leblanc T, Harker-Murray P. Transplant-Free Approach in Relapsed Hodgkin Lymphoma in Children, Adolescents, and Young Adults: A Nonrandomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):249-257. doi: 10.1001/jamaoncol.2024.5627.
Harker-Murray P, Mauz-Korholz C, Leblanc T, Mascarin M, Michel G, Cooper S, Beishuizen A, Leger KJ, Amoroso L, Buffardi S, Rigaud C, Hoppe BS, Lisano J, Francis S, Sacchi M, Cole PD, Drachtman RA, Kelly KM, Daw S. Nivolumab and brentuximab vedotin with or without bendamustine for R/R Hodgkin lymphoma in children, adolescents, and young adults. Blood. 2023 Apr 27;141(17):2075-2084. doi: 10.1182/blood.2022017118.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2016-002347-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-744
Identifier Type: -
Identifier Source: org_study_id
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