CheckMate908

• Research type

  Research Study

• Full title

  Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies

• IRAS ID

  224562

• Contact name

  Darren Hargrave

• Contact email

  darren.hargrave@nhs.net

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2016-004441-82

• Duration of Study in the UK

  3 years, 11 months, 5 days

• Research summary

  Summary of Research
  This is a multicentre, phase 1b/2 study involving investigational drugs called nivolumab and ipilimumab, in children and young adults (aged from 6 months to 22 years old) with certain types of brain cancer. Approximately 200 patients will take part globally, 9 of them will be from the UK. The study is sponsored by Bristol Myers Squibb (BMS).

  The patients will be included in one of five groups (or cohorts), depending on their tumour type. The five cohorts include patients with:
  - Diffuse intrinsic pontine glioma (DIPG) that was never treated before (Cohort 1)
  - Recurrent or progressive supratentorial high-grade gliomas (HGG) previously treated by surgical resection and radiotherapy (with or without chemotherapy) (Cohort 2)
  - Medulloblastoma that is recurrent or progressive after prior therapy (Cohort 3)
  - Ependymoma that is recurrent or progressive after prior therapy (Cohort 4)
  - Other recurrent or progressive tumour types after prior therapy (Cohort 5)

  Nivolumab and Ipilimumab are drugs that help the patients’ own immune system to fight against the tumour. The purpose of this study is to find out if nivolumab alone or nivolumab in combination with ipilimumab are safe, and have an effect against the different kinds of brain tumours.

  Following a screening period, eligible patients will be assigned to receive nivolumab alone or nivolumab with ipilimumab, depending on the stage of the trial. All medications are given intravenously (through a vein). Patients may be treated for more than 3 years, but the exact length of time will depend on the response to the treatment.
  Throughout the study, patients will undergo the following procedures: MRI scans, physical exams and vital signs, blood sampling, ECG and pregnancy testing. After completing the study treatment, patients will be asked to attend two follow-up visits, after which survival follow-up may continue for several months or years.

  Summary of Results
  Technical results of the study will be posted on Clinical Trials.gov and EudraCT

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  17/LO/0779

• Date of REC Opinion

  5 Jul 2017

• REC opinion

  Further Information Favourable Opinion