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)

October 13, 2021 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, NSW 2298
        • Local Institution
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Local Institution
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
  • Belgium
      • B-leuven, Belgium, 3000
        • Local Institution
      • Bruxelles, Belgium, 1200
        • Local Institution
      • Gent, Belgium, 9000
        • Local Institution
  • Canada
      • Montreal, Canada, H2X 3E4
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution
  • France
      • Creteil, France, 94010
        • Local Institution
      • Montpellier Cedex 05, France, 34295
        • Hopital Saint Eloi
      • Pierre Benite Cedex, France, 69495
        • Local Institution
      • Rennes, France, 35033
        • Local Institution
  • Germany
      • Erlangen, Germany, 91054
        • Local Institution
      • Essen, Germany, 45147
        • Local Institution
      • Homburg, Germany, 66424
        • Local Institution
      • Ulm, Germany, 89081
        • Local Institution
  • Italy
      • Bergamo, Italy, 24127
        • Local Institution
      • Bologna, Italy, 40138
        • Local Institution
      • Milano, Italy, 20133
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Roma, Italy, 00161
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution
      • Rotterdam, Netherlands, 3075 EA
        • Local Institution
      • Rotterdam, Netherlands, 3000 CA
        • Local Institution
      • Utrecht, Netherlands, 3584 CX
        • Local Institution
  • Singapore
      • Singapore, Singapore, 169608
        • Local Institution
      • Singapore, Singapore, 119228
        • Local Institution
  • Spain
      • Hospitalet Llobregat- Barcelona, Spain, 9908
        • Local Institution
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28009
        • Local Institution
      • Salamanca, Spain, 37007
        • Local Institution
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Local Institution
      • Lund, Sweden, 221 85
        • Local Institution
  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Local Institution
    • Manchester
      • Withington, Manchester, United Kingdom, M20 4BX
        • Local Institution
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Los Angeles, California, United States, 90095
        • Division Of Hematology & Oncology Ctr. For Health Sciences
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • New York, New York, United States, 10019
        • Columbia University Medical Center (Cumc)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivolumab (3 mg/kg)
Nivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity
Drug: Nivolumab
Other Names:
  • BMS-936558

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: 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.
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
Time Frame: 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.
From date of first dose to study completion (up to approximately 78 months)
Duration of Complete Remission
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)

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.
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
Time Frame: 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.
From date of first dose to study completion (up to approximately 78 months)
Duration of Partial Remission
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)

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.
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
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)
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.
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
Time Frame: 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.
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2014

Primary Completion (Actual)

April 8, 2016

Study Completion (Actual)

October 8, 2020

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-139
  • 2013-003621-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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