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)

Phase 2

Completed

• Conditions: Lymphoma. Non-Hodgkin
• Interventions: Drug: Nivolumab

• Registration Number: NCT02038933
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-17
• Study Start: 2014-03-05
• Primary Completion: 2016-04-08
• Disposition First Submitted: 2016-12-05
• Disposition First Submitted QC: 2016-12-05
• Disposition First Posted: 2016-12-06
• Results First Submitted: 2017-04-19
• Results First Submitted QC: 2017-04-19
• Results First Posted: 2017-05-30
• Study Completion: 2020-10-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab (3 mg/kg)	Nivolumab	Nivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment	From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months)	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

Secondary Outcome Measures

Name	Time	Method
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)	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.
Complete Remission Rate	From date of first dose to study completion (up to approximately 78 months)	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.
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)	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.
Partial Remission Rate	From date of first dose to study completion (up to approximately 78 months)	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.
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)	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.
Progression Free Survival	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)	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.
Objective Response Rate (ORR) Per Investigator Assessment	From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months)	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.

Trial Locations

Locations (13)

Local Institution; 🇬🇧 Sutton, Surrey, United Kingdom

Hopital Saint Eloi; 🇫🇷 Montpellier Cedex 05, France

John Theurer Cancer Center at Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

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

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Columbia University Medical Center (Cumc); 🇺🇸 New York, New York, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States