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RecruitingLast updated: 22 December 2025

KANDLELIT-012: A study of the drug MK-1084 with targeted therapy and chemotherapy in people with bowel cancer (colorectal cancer) with KRAS G12C mutationA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Trial acronym

KANDLELIT-012

Clinical summary

Summary

Researchers are looking for other ways to treat locally advanced or metastatic colorecal cancer (mCRC) that is unable to be removed through surgery (unresectable) and has a gene mutation called KRAS G12C.

Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 chemotherapy, with or without bevacizumab 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. MK-1084 and cetuximab are targeted therapies.

The goals of this study are to learn:

  • About the safety of MK-1084 with cetuximab and mFOLFOX6 and if people tolerate the treatments
  • If people who receive MK-1084 with cetuximab and mFOLFOX6 livelonger without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.

The study has two parts, and those participating in part 2 must not have received prior systemic anticancer therapy for their locally advanced, unresectable or metastatic disease.

 

Conditions

This trial is treating people with locally advanced, unresectable or metastatic bowel cancer that is KRAS G12C+

Eligibility

Inclusion

The main inclusion criteria include but are not limited to the following:

  • Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer [AJCC] eighth edition) colorectal adenocarcinoma
  • Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer
  • Tumor tissue demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion

The main exclusion criteria include but are not limited to the following:

  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has known dihydropyrimidine dehydrogenase (DPD) deficiency
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
  • Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease
  • Has active infection requiring systemic therapy
  • Has not adequately recovered from major surgery or have ongoing surgical complications
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT06997497 *
  • 2024-517232-22-00 *
  • 1084-012; MK-1084-012; KANDLELIT-012; U1111-1311-8311; JRCT2031250265

Trial sponsor

Merck Sharp & Dohme LLC

Scientific 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

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