PREMIUM

• Research type

  Research Study

• Full title

  PeRioperative Encorafinib+binimetinib in BRAFV600 MUtant clinically detected AJCC stage III (B/C/D) or oligometastatic stage IV Melanoma

• IRAS ID

  278086

• Contact name

  Pippa Corrie

• Contact email

  phillipa.corrie@nhs.net

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust

• Eudract number

  2019-004855-35

• ISRCTN Number

  ISRCTN14595136

• Duration of Study in the UK

  2 years, 11 months, days

• Research summary

  The PREMIUM trial is multi-centre, open label, two-arm, randomised phase II feasibility trial looking at the role of pre-operative encorafinib plus binimetinib (EncoBini) compared with the standard post-operative therapy, in patients with potentially resectable melanoma. Eligible patients will be randomised to receive either 8 weeks of pre-operative EncoBini, followed by surgery, then up to 44 weeks of EncoBini (EncoBini Arm); or to receive up to 52 weeks of the standard post-surgery treatment offered at their participating site (Standard Arm). The trial will look at whether EncoBini given before surgery, as part of a randomised trial, is accepted by these patients and their doctors; and whether there is a significant complete pathological response when pre-operative EncoBini is received. The research is funded by Pierre Fabre Ltd.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  21/EE/0200

• Date of REC Opinion

  11 Nov 2021

• REC opinion

  Further Information Favourable Opinion