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Clinical Trials List

Protocol NumberMK-1084-012
NCT Number(ClinicalTrials.gov Identfier)NCT06997497
Active

2025-06-10 - 2033-12-31

Phase III

Recruiting4

ICD-10C19

Malignant neoplasm of rectosigmoid junction

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9154.0

Malignant neoplasm of rectosigmoid junction

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Hung-Chih Hsu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hao-Wei Teng Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Min Yeh
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Colon Adenocarcinoma 、Rectal Adenocarcinoma

Objectives

Primary Objectives Part 1: To evaluate the safety and tolerability of MK-1084, cetuximab, and mFOLFOX6. Part 2: To compare the progression-free survival (PFS) of MK-1084, cetuximab, and mFOLFOX6 with or without mFOLFOX6 and bevacizumab, as assessed by a blinded independent central review (BICR) according to RECIST version 1.1 (Reactive Criteria for Response in Solid Tumors 1.1). Secondary Objectives – Part 2 • To compare the objective response rate (ORR) of MK-1084, cetuximab, and mFOLFOX6 with or without mFOLFOX6 and bevacizumab, as assessed by BICR according to RECIST 1.1. • To compare the overall survival (OS) of MK-1084, cetuximab, and mFOLFOX6 with or without mFOLFOX6 and bevacizumab. • Assess the duration of response (DOR) of MK-1084, cetuximab, and mFOLFOX6 compared to mFOLFOX6 with or without bevacizumab, as assessed by BICR according to RECIST 1.1. • Assess the safety and tolerability of MK-1084 with cetuximab and mFOLFOX6. • Assess the mean changes since baseline of MK-1084 and mFOLFOX6 plus cetuximab compared to mFOLFOX6 with or without bevacizumab. • Assess the time to deterioration of MK-1084, cetuximab, and mFOLFOX6 compared to mFOLFOX6 with or without bevacizumab.

Test Drug

錠劑

Active Ingredient

MK-1084

Dosage Form

110

Dosage

25 mg/tablet、50 mg/tablet

Endpoints

Part 1: Dose-limiting toxicities (DLT), adverse events (AEs), and treatment discontinuation due to AEs
Part 2: PFS: Time from randomization to the first recorded disease progression or death from any cause, whichever occurs first.

Inclution 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

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

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    477 participants

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