Combi-Aplus: Dabrafenib + Trametinib in BRAF+ve Melanoma

• Research type

  Research Study

• Full title

  COMBI-APlus: Open-label, phase IIIb study of dabrafenib in COMBInation with trametinib in the Adjuvant treatment of stage III BRAF V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm (Plus)

• IRAS ID

  240027

• Contact name

  Pippa Corrie

• Contact email

  pippa.corrie@addenbrookes.nhs.uk

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2018-000168-27

• Duration of Study in the UK

  2 years, 11 months, 4 days

• Research summary

  Research Summary
  Patients that were treated with dabrafenib and trametinib in a previous study (COMBI AD) developed an adverse event called Pyrexia which is a raised body temperature.
  This phase IIIb study will test whether using a different way of managing pyrexia will lower the number of times it is seen in patients being treated with dabrafenib and trametinib.
  This study will be open to participants who have melanoma with an altered protein called BRAF V600. The melanoma must have been completely removed and then the treatment of dabrafenib and trametinib can be given.

  The study will also look at how well this treatment works in these participants.
  At the beginning of the study participants will be told about the management of pyrexia and if symptoms are reported the doctors will make changes to the dose of the drug.
  The study has two stages:
  1. Treatment period (12 Months) – During this period participants will be given the treatment of dabrafenib and trametinib for up to 12 months.

  2. Follow up period (12 Months) – Follow-up will start once: 1) treatment is completed; or 2) patient discontinues treatment. The patients will continue in the follow up period for a maximum of 12 months or until withdrawal, lost to follow-up, death, or the end of study even if disease recurs.
  There are different assessment schedules depending on whether participants relapses during the study or not.

  Summary of Results
  Plain Language summaries will be available for distribution to patients and posting on the relevant websites in September 2022.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  18/WM/0190

• Date of REC Opinion

  6 Aug 2018

• REC opinion

  Further Information Favourable Opinion