Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)
- Registration Number
- NCT02038946
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1: Nivolumab Nivolumab Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) as Determined by IRRC From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) ORR is determined by an independent radiologic review committee (IRRC) according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants.
CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.
PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Based on IRRC Assessment From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) PFS was summarized descriptively using the Kaplan-Meier (KM) product-limit method. Median values of PFS, along with the two-sided 95% CIs were calculated using a method based on log-log transformation.
Complete Remission Rate (CRR) Based on IRRC Assessment From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) CRR is defined as the number of subjects with a BOR of CR according to the revised International Working Group Criteria for non-Hodgkin Lymphoma, divided by the number of treated participants and expressed as a percentage.
CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.Partial Remission (PR) Rate Based on IRRC Assessment From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) PR rate is defined as the number of participants with a best overall response (BOR) of PR according to the 2007 International Working Group (IWG) criteria, based on IRRC assessment, divided by the number of treated participants and expressed as a percentage.
PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)Duration of Response (DOR) Based on IRRC Assessments From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) DOR is defined as the time from first remission (CR or PR) to the date of initial objectively documented progression as determined using the revised International Working Group Criteria for non-Hodgkin Lymphoma, or death due to any cause, whichever occurs first.
CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir, as described in the IWG response criteriaOverall Response Rate (ORR) Based on Investigator Assessments From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) ORR is determined by investigator assessments according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is expressed as a percentage of all treated participants.
CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.
PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
Trial Locations
- Locations (21)
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Local Institution
🇬🇧Sutton, Surrey, United Kingdom
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
🇨🇦Rimouski, Quebec, Canada
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Division Of Hematology & Oncology Ctr. For Health Sciences
🇺🇸Los Angeles, California, United States
Winship Cancer Institute.
🇺🇸Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center (BIDMC)
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitaetsklinikum d. Saarlandes
🇩🇪Homburg, Germany
Hospital Duran I Reynals
🇪🇸Hospitalet Llobregat- Barcelona, Spain
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Universitaetsklinikum Des Saarlandes
🇩🇪Homburg, Germany