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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02038933
First received: January 15, 2014
Last updated: June 1, 2017
Last verified: June 2017
  Purpose
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

Condition Intervention Phase
Lymphoma. Non-Hodgkin Drug: Nivolumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 (assessed up to April 2016, approximately 25 months) ]
    ORR is defined as the number of subjects 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, divided by the number of treated subjects. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.


Secondary Outcome Measures:
  • Duration of Response (DOR) [ Time Frame: From date of first response to the date of documented disease progression or death, whichever occurs first (assessed up to April 2016, approximately 25 months) ]
    DOR is defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on 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 measureable disease and no new sites; SD= Failure to attain CR/PR or PD; PD= Any new lesion or increase by >=50% of previously involved sites from nadir.

  • Complete Remission Rate [ Time Frame: From date of first dose to date of documented CR ]
    Complete Remission Rate is defined as the number of subjects with a BOR of CR according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, divided by the number of treated subjects. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; SD= Failure to attain CR/PR or PD; PD= Any new lesion or increase by >=50% of previously involved sites from nadir.

  • 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 (Assessed up to April 2016, approximately 25 months) ]

    The duration of CR is defined as the time from first documentation of CR (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 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 measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.


  • Rate of Partial Remission [ Time Frame: From date of first dose to date of documentation of PR (assessed up to April 2016, approximately 25 months) ]

    PR rate is defined as the number of subjects with a BOR of PR according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, divided by the number of treated subjects.

    CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.


  • 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 (assessed up to April 2016, approximately 25 months) ]

    Duration of PR is defined as the time from first documentation of PR to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on 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 measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.


  • 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 (assessed up to April 2016, approximately 25 months) ]
    PFS is defined as the time from first dosing date to the date of the first documented progression, as determined by an 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 [ Time Frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to April 2016, approximately 25 months) ]

    ORR is defined as the number of subjects with a BOR of CR or PR, according to investigator assessment, divided by the number of treated subjects.

    CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.



Enrollment: 161
Actual Study Start Date: February 10, 2014
Estimated Study Completion Date: June 2, 2018
Primary Completion Date: April 8, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab (3 mg/kg)
Nivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity
Drug: Nivolumab
Other Name: BMS-936558

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038933

  Show 41 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02038933     History of Changes
Other Study ID Numbers: CA209-139
2013-003621-28 ( EudraCT Number )
Study First Received: January 15, 2014
Results First Received: April 19, 2017
Last Updated: June 1, 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017