Phase 3 study of MK-1084, Cetuximab, and mFOLFOX6 in mCRC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

• IRAS ID

  1011282

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06997497

• Research summary

  Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that has spread or cannot be surgically removed and has a gene mutation called KRAS G12C.
  Standard treatments for this type of colorectal cancer may include:
  • mFOLFOX6 – a chemotherapy
  • Bevacizumab – a targeted therapy
  Researchers want to learn if adding MK-1084 (the study medicine) and cetuximab to mFOLFOX6, can treat locally advanced or mCRC with the KRAS G12C mutation, and if participants tolerate the treatments. MK-1084 and cetuximab are targeted therapies.

  About 477 participants, at least 18 years old, with locally advanced or mCRC will be in this study.

  This study has 2 parts:
  • Part 1: A small group of participants will receive a target dose of MK-1084 with cetuximab and mFOLFOX6 to review the safety of the target dose. Part 2 will not be run if the target dose is not safe.
  • Part 2: Participants will be assigned by chance to one of these treatment groups:
  o Group A: MK-1084 with cetuximab and mFOLFOX6
  o Group B: mFOLFOX6 with or without bevacizumab.
  Participants will receive mFOLFOX6, cetuximab, and bevacizumab given into a vein as an intravenous (IV) infusion every 2 weeks. Participants will take MK-1084 by mouth as tablets once a day. Participants will receive treatment until the cancer gets worse or the treatment is not tolerated.
  Both the participants in the study and the researchers will know which study treatment a participant is getting. Participants may give urine, blood, and tumour samples during the study. They will have physical examinations, imaging tests, tests to check their heart (electrocardiograms or ECGs), and answer questions about how they are feeling. Participants may be in this study for up to about 3 years.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  25/LO/0442

• Date of REC Opinion

  11 Aug 2025

• REC opinion

  Further Information Favourable Opinion