Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of MK-1084, cetuximab and mFOLFOX6 combination compared to mFOLFOX6 with or without bevacizumab for patients with KRAS G12C-mutant advanced colorectal cancer

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating patients with Colorectal Cancer that is locally advanced, cannot be surgically removed, or has spread to other parts of the body (metastatic). Specifically, the cancer must have a particular genetic change called KRAS G12C mutation. The study will test a new drug called MK-1084 in combination with other cancer treatments including cetuximab (a targeted therapy) and mFOLFOX6 (a combination chemotherapy that includes oxaliplatin, fluorouracil, and calcium folinate).

The study will compare two different treatment approaches: one group will receive MK-1084, cetuximab, and mFOLFOX6, while the other group will receive mFOLFOX6 either alone or with another drug called bevacizumab. The main purpose is to determine if adding MK-1084 and cetuximab to standard chemotherapy is safe and effective for treating this specific type of colorectal cancer.

During the study, patients will receive their assigned treatments through a combination of oral tablets (MK-1084) and intravenous infusions (other medications). The medications will be given according to a specific schedule, and patients will be monitored regularly to assess how well the treatment is working and to check for any side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Treatment with MK-1084 (tablets taken by mouth), cetuximab (given through vein), and mFOLFOX6 therapy

    Group 2: Treatment with mFOLFOX6 therapy with or without bevacizumab (given through vein)

  2. Step 2

    Treatment administration

    The mFOLFOX6 therapy consists of:

    - Oxaliplatin (given through vein)

    - Fluorouracil (given through vein)

    - Calcium folinate (given through vein)

    If assigned to Group 1, you will take MK-1084 tablets daily and receive cetuximab through vein

    If assigned to Group 2, you may also receive bevacizumab through vein

  3. Step 3

    Regular health assessments

    Your health will be monitored regularly through:

    Physical examinations

    Quality of life questionnaires about your general health and specific symptoms

    Tests to check how your cancer responds to treatment

  4. Step 4

    Treatment duration

    Treatment will continue as long as it is helping and side effects are manageable

    The study is planned to run from September 2025 to May 2031

  5. Step 5

    Monitoring of side effects

    Any side effects will be closely monitored and recorded

    Treatment may be adjusted or stopped if necessary due to side effects

Who can join the trial?

9 criteria

  • Must have confirmed colorectal cancer (cancer of the large intestine) that is either locally advanced and cannot be surgically removed, or has spread to other parts of the body (Stage III or IV)
  • For Part 2 of the study: Must not have received any previous cancer treatments for advanced or metastatic colorectal cancer
  • Must have a specific genetic mutation called KRAS G12C in the tumor tissue
  • Participants who have HIV infection may participate if their condition is well-controlled with antiviral medications
  • Participants with Hepatitis B can participate if they:
    • Are receiving antiviral treatment
    • Have undetectable levels of the virus in their blood
    • Participants with a history of Hepatitis C can participate if they have undetectable levels of the virus in their blood
    • Must be an adult (18 years or older)
    • Both men and women can participate

Who cannot join the trial?

14 criteria

  • History of active brain metastases (cancer that has spread to the brain) or brain/spinal cord conditions
  • Previous treatment with any KRAS G12C inhibitor (specific type of cancer medication)
  • Known allergy or sensitivity to any of the study medications
  • Active autoimmune disease (condition where immune system attacks healthy cells) requiring systemic treatment
  • Uncontrolled hypertension (high blood pressure that cannot be managed with medication)
  • Major surgery within 4 weeks before starting the study treatment
  • Current participation in another clinical trial with an investigational drug
  • Serious heart conditions including:
    • Heart attack within the past 6 months
    • Unstable chest pain
    • Severe heart rhythm problems
    • Active or chronic hepatitis B or C infection (liver infections)
    • History of other cancers within the past 3 years, except for successfully treated:
      • Non-melanoma skin cancer
      • Early-stage cancer that has been completely removed
      • Pregnant or breastfeeding women
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • MK-1084

    is an investigational medication being studied for the treatment of colorectal cancer, specifically in patients with KRAS G12C mutation. It belongs to a class of targeted therapy drugs.

  • Cetuximab

    is a medication that targets a protein called EGFR (epidermal growth factor receptor) on cancer cells. It is an antibody therapy that helps stop cancer cells from growing and spreading.

  • mFOLFOX6

    is a combination chemotherapy regimen that includes several medications working together to kill cancer cells. It is commonly used to treat colorectal cancer.

  • Bevacizumab

    is a medication that works by blocking the formation of new blood vessels that feed tumors. It helps prevent cancer growth by cutting off the tumor's blood supply.

What is already known about the treatment

  • MK-1084

    An investigational targeted therapy medication being studied in clinical trials for KRAS G12C-mutant colorectal cancer, administered in combination with cetuximab and mFOLFOX6 chemotherapy regimen. The drug is currently being evaluated in Phase 3 clinical trials for patients with locally advanced unresectable or metastatic colorectal cancer as a first-line treatment option. The medication specifically targets the KRAS G12C mutation, which is a specific genetic alteration found in some colorectal cancers.

  • Cetuximab

    An intravenously administered targeted therapy that belongs to the class of monoclonal antibodies, specifically designed to block the epidermal growth factor receptor (EGFR) on cancer cells. This medication is already approved and commonly used in treating colorectal cancer, working by preventing cancer cell growth and survival signals. It is typically administered in combination with other cancer treatments to enhance therapeutic effectiveness.

  • Bevacizumab

    An intravenous medication that belongs to the class of monoclonal antibodies, working as an angiogenesis inhibitor by blocking the formation of new blood vessels that supply tumors. This established cancer medication is commonly used in treating various types of cancer, including colorectal cancer, and works by cutting off the blood supply to tumors, thereby limiting their growth and spread. It is often administered in combination with chemotherapy regimens like mFOLFOX6.

  • mFOLFOX6

    A combination chemotherapy regimen that includes multiple drugs (fluorouracil, leucovorin, and oxaliplatin) administered intravenously. This standard chemotherapy protocol is widely used in treating colorectal cancer, working through multiple mechanisms to kill rapidly dividing cancer cells. The regimen is administered in cycles and has been established as a backbone treatment for both early-stage and advanced colorectal cancer.

Investigated diseases

Colorectal Cancer - A disease that begins in either the colon or rectum, which are parts of the large intestine. It typically starts as small growths called polyps that form on the inner lining of the colon or rectum. Over time, some of these polyps can develop into cancer. In this specific case, the cancer has a KRAS G12C mutation, which means there is a specific change in the DNA of cancer cells. The cancer is considered locally advanced when it has grown through the wall of the colon or rectum and may have spread to nearby structures. When described as metastatic, it means the cancer has spread from its original location to other parts of the body.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517232-22-00Protocol codeMK-1084-012Estimated enrolment518 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).