Last updated 9 days ago
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
477 patients around the world
Available in Brazil, Colombia, Argentina, United States
This study will have 2 parts.
Merck Sharp & Dohme LLC
15Research 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
Hospital Privado de Córdoba
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital São Vicente de Paulo
Recruiting
CEPEN - CENTRO DE PESQUISA E ENSINO DE SANTA CATARINA
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
Hospital Nossa Senhora da Conceição
Recruiting
Instituto do Cancer Arnaldo Vieira de Carvalho
Recruiting
IBCC - Núcleo de Pesquisa e Ensino
Recruiting
StudyMK-1084-012/KANDLELIT-012
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Colon cancerRectal cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06997497
