Nivolumab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Research type

  Research Study

• Full 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

• IRAS ID

  146883

• Contact name

  Peter Johnson

• Contact email

  johnsonp@soton.ac.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2013-003621-28

• Duration of Study in the UK

  7 years, 4 months, 28 days

• Research summary

  This is a multi-centre, phase II study involving an investigational drug called Nivolumab given alone, in patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL). The purpose of the study is to determine if treatment with Nivolumab will lead to clinical benefit in these patients who previously relapsed or were non-responsive to an autologous stem cell transplant (ASCT), or who failed at least one prior multi-agent chemotherapy and are not candidates for ASCT.

  DLBCL is the most common lymphoid malignancy in adults and while many respond to initial chemotherapy, 30-40% fail first line therapy and have reduced success to further regimens or ASCT, leaving 10-15% with a poor prognosis.

  Approximately 120 patients will take part globally with approximately 9 coming from the UK. The study is sponsored by Bristol-Myers Squibb. Following a screening period, eligible patients will receive nivolumab intravenously (through the vein) every 2 weeks. Patients will undergo the following study procedures: Tumour biopsy (if one is not already available), CT/MRI/PET scans, physical exams, vital signs such as blood pressure, height, weight, body temperature and blood tests for routine safety testing and study specific testing. Patients will also be required to complete a questionnaire at regular intervals throughout the study.
  Patients can remain in the study for as long as they are tolerating the treatment or until it has been confirmed that their cancer has worsened. At the conclusion of the study, patients who continue to gain clinical benefit and are tolerating the study drug will be eligible to continue to receive the study drug.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  14/SC/0027

• Date of REC Opinion

  3 Feb 2014

• REC opinion

  Favourable Opinion