BridgeMD
A clinical study of MK-1084 with targeted therapy and chemotherapy in people with colorectal cancer (MK-1084-012).
EU CTIS ID: 2024-517232-22-00
What this study is testing
1. To evaluate the safety and tolerability of treatment with MK-1084, cetuximab, and mFOLFOX6 2. To compare MK-1084, cetuximab, and mFOLFOX6 versus mFOLFOX6 with or without bevacizumab with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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 history of stem cell/solid organ transplant
- 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.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has known dihydropyrimidine dehydrogenase (DPD) deficiency
See the full eligibility criteria
- 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
- 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 history of stem cell/solid organ transplant
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Turkey
- Australia
- United States
- Singapore
- United Kingdom
- Argentina
- Malaysia
- Hong Kong
- Ukraine
- Colombia
- Korea, Republic of
- Chile
- Israel
- China
- Brazil
- Philippines
- Japan
- Taiwan
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Turkey; Australia; United States; Singapore; United Kingdom and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.