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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
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
Time frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months)
Duration of Response (DOR)
DOR is defined as the time from first response (Complete Response (CR) or Partial Response (PR)) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites.
Time frame: 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
Complete Remission Rate is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan.
Time frame: From date of first dose to study completion (up to approximately 78 months)
Duration of Complete Remission
The duration of Complete Remission is defined as the time from first documentation of Complete Response (CR) (which is the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow \[if required\], whichever occurs later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan.
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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
...and 36 more locations
Time frame: 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
Partial Remission rate is defined as the percentage of participants with a Best Overall Response (BOR) of Partial Response (PR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. PR= Regression of measurable disease and no emergence of new sites.
Time frame: From date of first dose to study completion (up to approximately 78 months)
Duration of Partial Remission
Duration of Partial Remission is defined as the time from first documentation of Partial Response (PR) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. PR= Regression of measurable disease and no emergence of new sites.
Time frame: 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)
Progression Free Survival
Progression Free Survival (PFS) is defined as the time from first dosing date to the date of the first documented progression, as determined by an Independent Radiology Review Committee (IRRC) according to the 2007 revised IWG Criteria for Malignant Lymphoma, or death due to any cause, whichever occurs first.
Time frame: 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)
Objective Response Rate (ORR) Per Investigator Assessment
ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), according to investigator assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites.
Time frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months)