Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)
NCT ID: NCT02038933
Last Updated: 2021-10-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2014-03-05
2020-10-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nivolumab (3 mg/kg)
Nivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity
Nivolumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1
* At least one lesion that measures \>1.5 cm
* Prior therapy and screening lab criteria must be met
* Appropriate contraceptive measures must be taken
Exclusion Criteria
* History of interstitial lung disease, prior malignancy, active autoimmune disease, positive test for hepatitis B or hepatitis C virus
* Prior allogeneic stem cell transplant (SCT), chest radiation ≤ 24 weeks from study drug, ≥1000 mg of Carmustine Bis-chloroethylnitrosourea (BCNU) as part of pre-transplant conditioning regimen, prior treatment with drug targeting T-cell costimulation or immune checkpoint pathways
* Women who are breastfeeding or pregnant
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic Arizona
Phoenix, Arizona, United States
Division Of Hematology & Oncology Ctr. For Health Sciences
Los Angeles, California, United States
Winship Cancer Center
Atlanta, Georgia, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Medical Center (Cumc)
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Local Institution
Waratah, New South Wales, Australia
Local Institution
Woodville, South Australia, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
B-leuven, , Belgium
Local Institution
Brussels, , Belgium
Local Institution
Ghent, , Belgium
Local Institution
Montreal, Quebec, Canada
Local Institution
Montreal, , Canada
Local Institution
Créteil, , France
Hopital Saint Eloi
Montpellier, , France
Local Institution
Pierre-Bénite, , France
Local Institution
Rennes, , France
Local Institution
Erlangen, , Germany
Local Institution
Essen, , Germany
Local Institution
Homburg, , Germany
Local Institution
Ulm, , Germany
Local Institution
Bergamo, , Italy
Local Institution
Bologna, , Italy
Local Institution
Milan, , Italy
Local Institution
Napoli, , Italy
Local Institution
Roma, , Italy
Local Institution
Amsterdam, , Netherlands
Local Institution
Rotterdam, , Netherlands
Local Institution
Rotterdam, , Netherlands
Local Institution
Utrecht, , Netherlands
Local Institution
Singapore, , Singapore
Local Institution
Singapore, , Singapore
Local Institution
Hospitalet Llobregat- Barcelona, , Spain
Local Institution
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Local Institution
Salamanca, , Spain
Local Institution
Gothenburg, , Sweden
Local Institution
Lund, , Sweden
Local Institution
Southampton, Hampshire, United Kingdom
Local Institution
Withington, Manchester, United Kingdom
Local Institution
Sutton, Surrey, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A. Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-003621-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-139
Identifier Type: -
Identifier Source: org_study_id