An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas
NCT ID: NCT02581631
Last Updated: 2023-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
145 participants
INTERVENTIONAL
2016-02-11
2022-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab+Brentuximab Vedotin
Nivolumab+Brentuximab Vedotin dose as specified
Nivolumab
Brentuximab Vedotin
Interventions
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Nivolumab
Brentuximab Vedotin
Eligibility Criteria
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Inclusion Criteria
* Expression of CD30
* Subjects must be 18 years or older (≥ 15 years for PMBL)
Exclusion Criteria
* Active, known, or suspected autoimmune disease
15 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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Local Institution - 0017
Birmingham, Alabama, United States
University Of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Local Institution - 0012
Tampa, Florida, United States
Winship Cancer Institute.
Atlanta, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Local Institution - 0003
New York, New York, United States
Local Institution - 0010
New York, New York, United States
University Of Rochester
Rochester, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Bon Secours-St Francis Hosp
Greenville, South Carolina, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Local Institution - 0011
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hopital Saint Louis
Paris, , France
Local Institution - 0020
Pierre-Bénite, , France
Local Institution - 0018
Bergamo, , Italy
Local Institution - 0024
Bologna, , Italy
Istituto Clinico Humanitas
Rozzano (milano), , Italy
Local Institution - 0027
Hospitalet de Llobregat - Barcelona, , Spain
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Countries
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References
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Zinzani PL, Santoro A, Gritti G, Brice P, Barr PM, Kuruvilla J, Cunningham D, Kline J, Johnson NA, Mehta-Shah N, Lisano J, Wen R, Akyol A, Moskowitz AJ. Nivolumab combined with brentuximab vedotin for R/R primary mediastinal large B-cell lymphoma: a 3-year follow-up. Blood Adv. 2023 Sep 26;7(18):5272-5280. doi: 10.1182/bloodadvances.2023010254.
Zinzani PL, Santoro A, Gritti G, Brice P, Barr PM, Kuruvilla J, Cunningham D, Kline J, Johnson NA, Mehta-Shah N, Manley T, Francis S, Sharma M, Moskowitz AJ. Nivolumab Combined With Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-Cell Lymphoma: Efficacy and Safety From the Phase II CheckMate 436 Study. J Clin Oncol. 2019 Nov 20;37(33):3081-3089. doi: 10.1200/JCO.19.01492. Epub 2019 Aug 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2015-003286-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-436
Identifier Type: -
Identifier Source: org_study_id
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