Clinical trial NCT02038933: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma. Non-Hodgkin
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment
timeFrame: 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:
measure: Duration of Response (DOR)
timeFrame: From date of first response to the date of documented disease progression or death, whichever occurs first (up to approximately 18 months)
measure: Complete Remission Rate
timeFrame: From date of first dose to study completion (up to approximately 78 months)
measure: Duration of Complete Remission
timeFrame: 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)
measure: Partial Remission Rate
timeFrame: From date of first dose to study completion (up to approximately 78 months)
measure: Duration of Partial Remission
timeFrame: 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)
measure: Progression Free Survival
timeFrame: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (up to approximately 2 months)
measure: Objective Response Rate (ORR) Per Investigator Assessment
timeFrame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Division Of Hematology & Oncology Ctr. For Health Sciences
state: California
city: Atlanta
country: United States
facility: Winship Cancer Center
state: Georgia
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center (Cumc)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Waratah
country: Australia
facility: Local Institution
state: New South Wales
city: Woodville
country: Australia
facility: Local Institution
state: South Australia
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: B-leuven
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
city: Creteil
country: France
facility: Local Institution
city: Montpellier Cedex 05
country: France
facility: Hopital Saint Eloi
city: Pierre Benite Cedex
country: France
facility: Local Institution
city: Rennes
country: France
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Homburg
country: Germany
facility: Local Institution
city: Ulm
country: Germany
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution
city: Bologna
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Utrecht
country: Netherlands
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Hospitalet Llobregat- Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Salamanca
country: Spain
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Southampton
country: United Kingdom
facility: Local Institution
state: Hampshire
city: Withington
country: United Kingdom
facility: Local Institution
state: Manchester
city: Sutton
country: United Kingdom
facility: Local Institution
state: Surrey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.