PDR001 with dabrafenib + trametinib in BRAF+ve advanced Melanoma

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600 mutant melanoma

• IRAS ID

  219950

• Contact name

  Krunal Shah

• Contact email

  krunal.shah@novartis.com

• Sponsor organisation

  Novartis Pharmaceutical UK Limited

• Eudract number

  2016-002794-35

• Clinicaltrials.gov Identifier

  NCT02967692

• Duration of Study in the UK

  3 years, 10 months, 16 days

• Research summary

  This Phase III study will test whether adding an anti-PD1 antibody, called PDR001, to the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib is better, worse or the same as just giving dabrafenib and trametinib.

  This study will be open to participants who have advanced melanoma with an altered protein called BRAF V600. The melanoma is described as advanced when it cannot be removed by surgery or has spread other parts of the body. The participants won’t have received previous anti-cancer drug treatment for their advanced melanoma. The study will consist of 3 parts:

  Part 1: Safety run-in

  6 to 18 participants: Part 1 will find the dose of PDR001 which can be given alongside dabrafenib and trametinib without causing unbearable side effects. This dose will be used for Parts 2 and 3

  Part 2: Biomarker cohort
  20 participants: In part 2, all patients will be given PDR001+dabrafenib+trametinib. Biopsies (samples of the melanoma) and blood samples will be used to find out if dabrafenib and trametinib are helping immune cells to reach the cancer and increasing the ability of PDR001 to kill the melanoma.

  Part 3: Randomised, double-blind, placebo-controlled part
  500 participants: 250 participants will receive PDR001+dabrafenib+trametinib and another 250 will receive dabrafenib+trametinib. The anti-cancer effects, side effects and quality of life for each treatment will be measured and compared.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  17/LO/0065

• Date of REC Opinion

  8 Feb 2017

• REC opinion

  Further Information Favourable Opinion