MK-1084 Tumour-agnostic Study

• Research type

  Research Study

• Full title

  A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination with Cetuximab, in Participants with KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)

• IRAS ID

  1012444

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers want to learn about new ways to treat advanced solid tumours that have a gene mutation called KRAS G12C. KRAS G12C can make tumours harder to treat.

  Cetuximab is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread.
  MK-1084 (the trial medicine) is a targeted therapy designed to treat KRAS G12C mutations.

  Researchers want to learn if MK-1084 given alone or with cetuximab can treat certain advanced solid tumours in people with the KRAS G12C mutation.

  The goals of this trial are to learn:
  • How many people have the cancer respond (get smaller or go away) to MK-1084 alone or with cetuximab and how these responses compare
  • About the safety of MK-1084 alone or with cetuximab and if people tolerate the treatments

  About up to 150 people with solid tumours aged 18 years or older will take part in this trial if they meet certain criteria, including:
  • Have an advanced solid tumour with the KRAS G12C gene mutation
  • Have cancer that has not improved after prior treatment, or does not have other treatment options
  • Do not have certain heart diseases

  Researchers will assign people by equal chance to 1 of 2 trial treatment groups:
  • Group A will receive MK-1084 alone
  • Group B will receive MK-1084 and cetuximab
  MK-1084 is given daily by mouth as tablets.
  Cetuximab is given into a vein as an intravenous infusion once every 2 weeks.

  Both the people in the trial and the researchers will know which trial treatment a person is getting (open-label).

  A person may be in this trial for about 4 years.

  During the trial, people may give urine and blood samples, have tumour and imaging tests, have physical examinations and answer questions about how they are feeling.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  25/YH/0225

• Date of REC Opinion

  5 Dec 2025

• REC opinion

  Further Information Favourable Opinion