Study of MEK or dacarbazine in previously untreated melanoma patients

• Research type

  Research Study

• Full title

  A multicentre, open label, randomized Phase II trial of the MEK inhibitor Pimasertib or Dacarbazine in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma

• IRAS ID

  110661

• Contact name

  James Larkin

• Sponsor organisation

  Merck Serono S.A. Geneva

• Eudract number

  2012-002669-37

• ISRCTN Number

  000000

• Clinicaltrials.gov Identifier

  000000

• Research summary

  Advanced melanoma is an aggressive incurable form of cancer with an average survival of 7-10 months. Limited therapeutic options exist and five-year survival for patients with disseminated (spread) melanoma is 5-10%. This study investigates a new kind of anti-cancer treatment. Pimasertib (an experimental drug) is being compared to Dacarbazine (licensed drug). The main purpose of this open-label study is to determine the effects and safety of both drugs and compare the progression-free survival (PFS) of both groups of patients. Patients with melanoma often have a defect or mutation in the BRAF and N-Ras gene in their tumour cells. In this study, patients with previously untreated N-Ras mutated melanoma will be given Pimasertib (orally twice daily) or Dacarbazine (injected intravenously 3 weekly). Pimasertib belongs to a family of molecules called MEK inhibitors. MEK is a molecule involved in the growth of human cells and also the abnormal growth of cancer cells. Approximately 184 participants will be recruited, the study will take 26 months to complete (14 months enrollment; 12 months follow-up). Treatment consists of repeated 21-day cycles and continues until disease progression, unacceptable toxicity, informed consent withdrawal or death. Study visits are on Days 1, 8 and 15 of the first 2 cycles; every 21 days thereafter. Tests to be performed during the study visits include: physical examinations, blood pressure, ECG??s, echocardiogram, quality of life questionnaire and blood and urine samples. Ophthalmologic assessments will be performed if participants are under experimental drug, Pimasertib. Tumour tests will be performed to determine whether any shrinkage has occurred. These will include CT or MRI scans of chest, abdomen, pelvis and other areas if needed, pictures of lesions and bone scans (if applicable). The study is sponsored by Merck Serono in Geneva.

• REC name

  Wales REC 3

• REC reference

  12/WA/0312

• Date of REC Opinion

  14 Dec 2012

• REC opinion

  Further Information Favourable Opinion