Phase 2 Study of MK-6482 in Participants With Advanced RCC

• Research type

  Research Study

• Full title

  Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma

• IRAS ID

  1003437

• Contact name

  Mark Tuthill

• Contact email

  Mark.Tuthill@ouh.nhs.uk

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2020-001907-18

• Research summary

  Worldwide, there were 403,262 new cases of kidney cancer and 175,098 deaths due to the disease reported in 2018. Renal Cell
  Carcinoma (RCC) comprises approximately 3.7% of all cancers, with a median age at diagnosis of 64 years.
  RCC accounts for approximately 85% of all kidney cancers. A substantial proportion of patients with RCC progress to advanced
  stage disease; about one-third of patients cannot be treated with surgery or have secondary cancer growths at diagnosis, and
  between 20% to 30% of patients with localised tumours will eventually relapse after nephrectomy (removal of some or all the
  kidney).
  Early-lines of treatment for patients with advanced RCC include drugs known as vascular endothelial growth factor (VEGF)-
  targeting and immunotherapy agents. However, there is currently no evidence-based treatment recommendation for the optimal
  management of patients in the late-line setting (i.e. after immunotherapy and VEGF-targeting therapy).
  MK-6482 is a small molecule that selectively and potently inhibits a protein called HIF-2α. HIF-2α is known to combine with
  HIF-1B to form a heterodimeric (2-protein) complex, which tumour cells can use to encourage the formation more of cancer cells.
  MK-6482 also blocks the transcription of several genes involved in oncogenesis (formation of cancer cells).
  This study will evaluate the efficacy and safety of the 120 mg taken daily (QD) dose compared with the 200 mg QD dose of
  MK-6482, in participants with advanced RCC with clear cell component after prior therapy. Approximately 150 eligible
  participants will be randomly assigned in a 1:1 ratio to receive either 120 mg QD or 200 mg QD of MK-6482 (approximately 75
  participants in each arm) for approximately 4 years.
  The study is funded by Merck Sharp & Dohme Limited and will take place at 5 study centres in the UK.
  

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  20/NW/0463

• Date of REC Opinion

  23 Feb 2021

• REC opinion

  Further Information Favourable Opinion