A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

Launched by MERCK SHARP & DOHME LLC · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced or metastatic colorectal cancer that cannot be surgically removed. Specifically, researchers want to see if a combination of a study medication called MK-1084, another medication called cetuximab, and standard chemotherapy (mFOLFOX6) can be more effective than the usual treatments, which may include mFOLFOX6 with or without a drug called bevacizumab. The trial focuses on patients whose cancer has a specific gene mutation known as KRAS G12C, which can affect how the cancer responds to treatment.

To participate in this study, patients should have confirmed, advanced colorectal cancer with the KRAS G12C mutation and should not have received prior systemic treatments for this condition. Other eligibility requirements include being between the ages of 65 and 74 and having well-managed health conditions like HIV or hepatitis, if applicable. Participants can expect to receive the study medications while being closely monitored for safety and effectiveness. This trial aims to help researchers understand if this new combination of treatments can help patients live longer without the cancer growing or spreading.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 Criteria:
• 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