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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Centre Hospitalier Universitaire Rouen Rouen France
Hospital General Universitario Gregorio Maranon Madrid Spain
Amphia Hospital Breda The Netherlands
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie Poznan Poland
Radiotherapy Center Cluj S.R.L. Floresti Romania
Institut Sainte Catherine Avignon France
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Mruk-Med I Sp. z o.o. Rzeszow Poland
Institut Godinot Reims France
Katholisches Marienkrankenhaus gGmbH Hamburg Germany
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universita’ Degli Studi Di Verona Verona Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Nice Nice France
University Of Pecs Pecs Hungary
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Pirkanmaan hyvinvointialue Tampere Finland
Hopital Beaujon Clichy France
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Centre Francois Baclesse Caen France
Fundeni Clinical Institute Bucharest Romania
Hewxkjax Uaqwxqgflodtd Msicgav Db Vojafnmjye Santander Spain
Cnseav Hnicutfgfbz Es Uhxuauuwqskwl De Lmuwaij Limoges France
Aemuwxxsj Ukl Amsterdam The Netherlands
Hoyeutub Uaenknmjck Camecjd Husyoyon Helsinki Finland
Elsqmvk Uktdtbcasali Mgslavl Cqrdoqf Rsdgndnxx (qbbcmqf Mvr Rotterdam The Netherlands
Cbun Dy Nuyxu Vandoeuvre Les Nancy France
Nyrmednb Izizwqrv Oimuguvsa Ibj Mfdja Snxdhllpspgrtsmfxkxkwbwahqxj Ihxcdrru Bfrempgz Cracow Poland
Gxtsej Uvrqvhofyj Fnvdpngam Frankfurt Germany
Ilbphhze Ciawqv Dxzgbfcxrvrujnajv L'hospitalet De Llobregat Spain
Kycsidxh Ewzojvdswlzixqwenlqrortq Hdqqksfskrktuqohf Essen Germany
Hizwcpns Vqde dmcqrjpb Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
29.09.2025
France France
Recruiting
29.09.2025
Germany Germany
Recruiting
29.09.2025
Hungary Hungary
Recruiting
29.09.2025
Italy Italy
Recruiting
29.09.2025
Poland Poland
Recruiting
29.09.2025
Romania Romania
Recruiting
29.09.2025
Spain Spain
Recruiting
29.09.2025
The Netherlands The Netherlands
Recruiting
29.09.2025

Trial locations

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.

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 ID:
2024-517232-22-00
Protocol code:
MK-1084-012
Trial Phase:
Therapeutic confirmatory (Phase III)

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