CA209-205

• Research type

  Research Study

• Full title

  Non-Comparative, Two-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in classical Hodgkin Lymphoma (cHL) Subjects with Relapsed or Progressive Disease after Failure of Autologous Stem Cell Transplant (ASCT)

• IRAS ID

  157949

• Contact name

  Prof. John Radford

• Contact email

  John.Radford@manchester.ac.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2014-001509-42

• Research summary

  Summary of Research
  Just over 1,600 people are diagnosed with Hodgkin Lymphoma in the UK each year. For patients diagnosed and treated for advanced classical Hodgkin's Lymphoma (cHL), 30% will eventually relapse. Standard of care treatment for patients who relapse after initial treatment is to receive an autologous stem cell transplant (ASCT) followed by treatment with a drug called brentuximab. While brentuximab has shown to improve disease response and survival time for ASCT failed cHL patients, most patients usually do not survive beyond two years after treatment.
  There remains an unmet need for new treatments to improve the prognosis for this group of patients.
  Nivolumab, a BMS experimental immuno-oncology drug currently in development, is being studied to determine whether it would enable the body’s own immune system resume its ability to attack cancer cells.
  CheckMATE 205 is a phase II study of nivolumab in previously treated cHL patients whose disease has relapsed or worsened. The purpose of the study is to determine if treatment with nivolumab will improve disease response and overall survival for patients and to expand the safety profile of nivolumab. The study will specifically aim to enroll 120 eligible cHL patients (with approximately 15 treated in the UK) who have received prior brentuximab treatment after their ASCT (60 patients) versus those who did not receive brentuximab but had an ASCT (60 patients).
  Following a screening period, all patients will receive nivolumab every two weeks until their cancer gets worse. Patients will undergo the following procedures during the study: tumour tissue biopsy, CT/MRI scans, physical exams, vital signs and blood sample collection for routine safety testing and study specific testing.
  Patients will be treated by trained oncology teams in specialised NHS clinics in the UK. The study is sponsored by Bristol-Myers Squibb.

  Summary of Results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbZq0EsBauKrqnM0hVPR7WPxEOAdI8dk583jmmvC4q09cDPmm57dehpFhJd27OL2i0VVNioafgYTTt0K8NfAb4p28niAQk9Gq573CVe-2F2af6syStk_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIOn-2BNqRo5Q2JEnBqcQGmDWlLbOls0DB5OElmCBz0GI8rZdws3Svif9Wv4EvH3Z9IkkRTYr-2FbnHOQQijnXiTPGtjnIP-2BiGoDlqzIka-2F1YqeYNSHw8YBeJeV6vZLiLrgr3RcFWbo6YCcLlHl3rVaP-2FuT2ttVmbRVIqlAScKVpUMv2g-3D-3D&data=05%7C01%7Cgmsouth.rec%40hra.nhs.uk%7C846b4113b3f045422a0f08dbf12090eb%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638368894395291289%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=KHPmGSgx75uPSX7Y9YKIk1algsdue3s7ZuJqbfoz41w%3D&reserved=0

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  14/NW/1084

• Date of REC Opinion

  22 Aug 2014

• REC opinion

  Further Information Favourable Opinion