a clinical study of mk-1084 with targeted therapy and chemotherapy in people with colorectal cancer (mk-1084-012/kandlelit-012)

Conditions: Colon Adenocarcinoma; Rectal Adenocarcinoma

Summary: researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mcrc) that is unresectable and has a gene mutation called kras g12c. standard (or usual) treatments for this type of colorectal cancer may include mfolfox6 with or without bevacizumab. 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 live longer without mcrc growing or spreading compared to people who receive mfolfox6 with or without bevacizumab.

this study will have 2 parts.

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