Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)
Conditions
Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Nivolumab
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- Grade 1, 2, or 3a FL without pathologic evidence of transformation

- Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or =2 prior treatment lines; each of the 2 prior treatment lines must include at least CD20 antibody and/or an alkylating agent

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

Exclusion Criteria:

- Known central nervous system lymphoma

- History of interstitial lung disease

- Subjects with active, known or suspected autoimmune disease

- Prior allogeneic stem cell transplant

- Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug
Locations
Mayo Clinic
Scottsdale, Arizona, United States
Status: Recruiting
Contact: Craig Reeder, Site 0040 - 480-301-6740
Ucla Hematology/Oncology
Los Angeles, California, United States
Status: Recruiting
Contact: John Timmerman, Site 0008 - 310-794-4820
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Jonathon Cohen, Site 0004 - 404-778-3255
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Philippe Armand, Site 0046 - 617-667-3064
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Philippe Armand, Site 0007 - 617-632-5221
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Philippe Armand, Site 0047 - 617-726-6602
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Stephen Ansell, Site 0002 - 507-284-4285
Weill Cornell Medical College
New York, New York, United States
Status: Recruiting
Contact: John Leonard, Site 0009 - 212-746-2062
Duke University Medical Center
Durham, North Carolina, United States
Status: Recruiting
Contact: Anne Beaven, Site 0011 - 919-681-4769
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Nishitha Reddy, Site 0006 - 615-936-4585
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Sattva Neelapu, Site 0035 - 713-563-9216
University Of Utah
Salt Lake City, Utah, United States
Status: Recruiting
Contact: Ahmad Halwani, Site 0001 - 321-841-4348
Local Institution
Woodville, South Australia, Australia
Status: Recruiting
Contact: Site 0033
Local Institution
Parkville, Victoria, Australia
Status: Recruiting
Contact: Site 0034
Local Institution
B-leuven, MA, Belgium
Status: Recruiting
Contact: Site 0012
Local Institution
Bruxelles, MA, Belgium
Status: Recruiting
Contact: Site 0013
Local Institution
Gent, South Australia, Belgium
Status: Recruiting
Contact: Site 0014
Jewish General Hospital
Montreal, Quebec, Canada
Status: Recruiting
Contact: Sarit Assouline, Site 0039 - +51-434-0822
Centre De Sante Et De Services Sociaux Rimouski Neigette
Rimouski, Quebec, Canada
Status: Recruiting
Contact: Katerine Marquis, Site 0049 - 418-724-3000
Local Institution
Rennes, MA, France
Status: Recruiting
Contact: Site 0025
Local Institution
Creteil, Surrey, France
Status: Recruiting
Contact: Site 0024
Local Institution
Pierre Benite Cedex, Surrey, France
Status: Recruiting
Contact: Site 0023
Local Institution
Montpellier Cedex 05, TN, France
Status: Recruiting
Contact: Site 0030
Universitaetsklinikum Des Saarlandes
Homburg, MA, Germany
Status: Recruiting
Contact: Michael Pfreundschuh, Site 0048
Local Institution
Regensburg, Surrey, Germany
Status: Recruiting
Contact: Site 0038
Universitaetsklinikum Ulm
Ulm, TN, Germany
Status: Recruiting
Contact: Christian Buske, Site 0045
Universitaetsklinikum Essen
Essen, TX, Germany
Status: Recruiting
Contact: Jan Duerig, Site 0037
Local Institution
Bologna, MA, Italy
Status: Recruiting
Contact: Site 0026
Local Institution
Milano, MA, Italy
Status: Recruiting
Contact: Site 0027
Local Institution
Napoli, MA, Italy
Status: Recruiting
Contact: Site 0042
Local Institution
Bergamo, Surrey, Italy
Status: Recruiting
Contact: Site 0028
Local Institution
Roma, TN, Italy
Status: Recruiting
Contact: Site 0031
Local Institution
Oslo, TN, Norway
Status: Recruiting
Contact: Site 0021
Local Institution
Singapore, MA, Singapore
Status: Recruiting
Contact: Site 0044
Local Institution
Singapore, NC, Singapore
Status: Recruiting
Contact: Site 0043
La Paz
Madrid, GA, Spain
Status: Recruiting
Contact: Miguel Angel Canales, Site 0019
Local Institution
Salamanca, MA, Spain
Status: Recruiting
Contact: Site 0050
Hospital Duran I Reynals
Hospitalet Llobregat- Barcelona, TN, Spain
Status: Recruiting
Contact: Santiago Mercadal, Site 0041
Local Institution
Madrid, TN, Spain
Status: Recruiting
Contact: Site 0022
Local Institution
Gothenberg, MA, Sweden
Status: Recruiting
Contact: Site 0020
Local Institution
Southampton, Hampshire, United Kingdom
Status: Recruiting
Contact: Site 0015
Local Institution
Withington, Manchester, United Kingdom
Status: Recruiting
Contact: Site 0017
Local Institution
Sutton, Surrey, United Kingdom
Status: Recruiting
Contact: Site 0016
Start Date
March 2014
Completion Date
August 2016
Sponsors
Bristol-Myers Squibb
Source
Bristol-Myers Squibb
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page