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)
A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT
2 other identifiers
interventional
121
12 countries
46
Brief Summary
The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2014
Longer than P75 for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2014
CompletedFirst Posted
Study publicly available on registry
January 17, 2014
CompletedStudy Start
First participant enrolled
March 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2016
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2020
CompletedOctober 14, 2021
October 1, 2021
2.1 years
January 15, 2014
April 19, 2017
October 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment
ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months)
Secondary Outcomes (7)
Duration of Response (DOR)
From date of first response to the date of documented disease progression or death, whichever occurs first (up to approximately 18 months)
Complete Remission Rate
From date of first dose to study completion (up to approximately 78 months)
Duration of Complete Remission
From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (up approximately 14 months)
Partial Remission Rate
From date of first dose to study completion (up to approximately 78 months)
Duration of Partial Remission
From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (up to approximately 12 months)
- +2 more secondary outcomes
Study Arms (1)
Nivolumab (3 mg/kg)
EXPERIMENTALNivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity
Interventions
Eligibility Criteria
You may qualify if:
- Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL)
- 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
You may not qualify if:
- Known central nervous system (CNS) lymphoma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Division Of Hematology & Oncology Ctr. For Health Sciences
Los Angeles, California, 90095, United States
Winship Cancer Center
Atlanta, Georgia, 30322, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University Medical Center (Cumc)
New York, New York, 10019, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Local Institution
Waratah, New South Wales, NSW 2298, Australia
Local Institution
Woodville, South Australia, 5011, Australia
Local Institution
Heidelberg, Victoria, 3084, Australia
Local Institution
B-leuven, 3000, Belgium
Local Institution
Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Montreal, Quebec, H3T 1E2, Canada
Local Institution
Montreal, H2X 3E4, Canada
Local Institution
Créteil, 94010, France
Hopital Saint Eloi
Montpellier, 34295, France
Local Institution
Pierre-Bénite, 69495, France
Local Institution
Rennes, 35033, France
Local Institution
Erlangen, 91054, Germany
Local Institution
Essen, 45147, Germany
Local Institution
Homburg, 66424, Germany
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Ulm, 89081, Germany
Local Institution
Bergamo, 24127, Italy
Local Institution
Bologna, 40138, Italy
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Milan, 20133, Italy
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Napoli, 80131, Italy
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Roma, 00161, Italy
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Amsterdam, 1066 CX, Netherlands
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Rotterdam, 3000 CA, Netherlands
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Rotterdam, 3075 EA, Netherlands
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Utrecht, 3584 CX, Netherlands
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Singapore, 119228, Singapore
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Singapore, 169608, Singapore
Local Institution
Hospitalet Llobregat- Barcelona, 9908, Spain
Local Institution
Madrid, 28009, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Local Institution
Salamanca, 37007, Spain
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Gothenburg, 413 45, Sweden
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Lund, 221 85, Sweden
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Southampton, Hampshire, SO16 6YD, United Kingdom
Local Institution
Withington, Manchester, M20 4BX, United Kingdom
Local Institution
Sutton, Surrey, SM2 5PT, United Kingdom
Related Publications (1)
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.
PMID: 30620669DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2014
First Posted
January 17, 2014
Study Start
March 5, 2014
Primary Completion
April 8, 2016
Study Completion
October 8, 2020
Last Updated
October 14, 2021
Results First Posted
May 30, 2017
Record last verified: 2021-10