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 currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02038933
First received: January 15, 2014
Last updated: September 22, 2014
Last verified: September 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:
  • Independent radiologic review committee (IRRC)-assessed objective response rate (ORR) [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
    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 revised International Working Group Criteria for non-Hodgkin Lymphoma, divided by the number of treated subjects


Secondary Outcome Measures:
  • Duration of ORR (DOR) based on IRRC assessment [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
    DOR is defined as the time from first response (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

  • Complete remission rate (CRR) and duration of CR based on IRRC assessment [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
    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 subjects

  • IRRC-assessed progression free survival (PFS) [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
    It is defined as the time from first dosing date to the date of the first documented progression, as determined by an IRRC, or death due to any cause, whichever occurs first

  • Investigator-assessed ORR [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
  • PR rate and duration of PR based on IRRC assessment [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
    PR rate is defined as the number of subjects with a BOR of PR according to the 2007 revised IWG response criteria, based on IRRC assessment, divided by the number of treated subjects


Estimated Enrollment: 120
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 38 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02038933     History of Changes
Other Study ID Numbers: CA209-139, 2013-003621-28
Study First Received: January 15, 2014
Last Updated: September 22, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014