Last updated 2 days ago
A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
477 patients around the world
Available in Argentina, United States
This study will have 2 parts.
Merck Sharp & Dohme LLC
1Research sites
477Patients around the world
This study is for people with
Colorectal cancer
Colon cancer
Rectal cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic 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 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.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.
Sites
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Colon cancerRectal cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06997497
