The LOGIC 2 study in BRAF melanoma

• Research type

  Research Study

• Full title

  A phase II, multi-centre, open-label study of sequential LGX818/MEK162 combination followed by a rational combination with targeted agents after progression, to overcome resistance in adult patients with locally advanced or metastatic BRAF V600 melanoma

• IRAS ID

  155067

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2013-004552-38

• Clinicaltrials.gov Identifier

  NCT02159066

• Duration of Study in the UK

  1 years, 9 months, 2 days

• Research summary

  This is a multicentre, open-label, phase II study which will enroll approximately 140 patients with BRAF mutant locally advanced unresectable or metastatic melanoma. This study consists of two parts: in Part I, patients who have not previously received selective BRAF and MEK inhibitors will be treated with the LGX818/MEK162 combination until disease progression.Based on the genetic assessment of a tumour biopsy obtained at progression of disease (PD), patients will enter Part II of the study for tailored combination treatment in one of four arms: LGX818/MEK162 + BKM120, BGJ398, INC280 or LEE011.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  15/SC/0075

• Date of REC Opinion

  1 Apr 2015

• REC opinion

  Further Information Favourable Opinion