CheckMate401: Nivolumab + Ipilimumab trial of subjects with melanoma

• Research type

  Research Study

• Full title

  Clinical Trial of Nivolumab (BMS-936558) Combined with Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects with Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma

• IRAS ID

  189797

• Contact name

  Pippa Corrie

• Contact email

  Corrie, Pippa <pippa.corrie@addenbrookes.nhs.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2015-001274-17

• Duration of Study in the UK

  7 years, 0 months, 1 days

• Research summary

  This is a multicentre study of Nivolumab (BMS-936558) combined with Ipilimumab Followed by Nivolumab monotherapy as initial treatment for patients with advanced melanoma (unresectable stage III or Stage IV melanoma). The study is funded by Bristol-Myers Squibb Research and Development.

  Approximately 768 subjects will be considered for the study and with around 85 participants expected to be treated in the UK. The treatment will last for up to 2 years and total duration of participation for individual subjects is expected to be up to 5 years.

  Eligible subjects will be treated with nivolumab 1 mg/kg infusion through the vein (IV) and ipilimumab 3 mg/kg IV infusion every 3 weeks for 4 doses, later followed by nivolumab alone at 3 mg/kg IV every 2 weeks for a maximum of 24 months from first combination dose, or unacceptable toxicity or until disease progression (although they may be still treated under certain circumstances). Patients will be followed by either direct contact (office visit) or via telephone contact for up to 100 days after the last dose of therapy. If therapy stopped during combination therapy of nivolumab and ipilimumab patients’ follow up will be every 4 weeks, if nivolumab monotherapy is stopped, the follow up will be every 30 days. Thereafter, patients will be followed for survival every 24 weeks for up to total of 5 years from the first day of treatment.

  This study involves procedures including: Medical history, physical examinations, vital signs, performance status, blood tests, questionnaires and CT/MRI scans.
  

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  15/EE/0448

• Date of REC Opinion

  23 Mar 2016

• REC opinion

  Further Information Favourable Opinion