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Clinical Trials List

Protocol NumberC4221015
NCT Number(ClinicalTrials.gov Identfier)NCT04607421
Active

2021-10-18 - 2026-11-22

Phase III

Recruiting8

ICD-10Z85.038

Personal history of other malignant neoplasm of large intestine

ICD-9V10.05

Personal history of malignant neoplasm of large intestine

AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Hwei-Ming Wang 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 Jaw-Yuan Wang Division of Colorectal Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial 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 陳彥勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Li Wei 無
Taipei Medical University Hospital

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 Yu-Min Yeh
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Neoplasms

Objectives

To evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes in previously untreated mCRC participants with BRAF V600E mutations, compared to current standard-of-care chemotherapy.

Test Drug

膠囊劑
注射劑
注射劑
注射劑
注射劑
注射劑
注射劑
錠劑
輸注液

Active Ingredient

Encorafenib
Cetuximab
Fluorouracil
Calcium folinate
Leucovorin calcium
Irinotecan hydrochloride
Oxaliplatin
Capecitabine
Bevacizumab

Dosage Form

130
270
270
270
270
270
270
110
27C

Dosage

75 mg
5 mg/mL
50 mg/mL
10 mg/mL
350 mg
20 mg/mL
150 mg/ 500 mg
25 mg/mL

Endpoints

Incidence of dose-limiting toxicities (DLT)

Inclution Criteria

Inclusion Criteria:

Safety Lead-In = Male/female ≥ 18 years old
Phase 3 and Cohort 3: Male/female ≥ 16 years old (where permitted locally)
Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment )
Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in)
ECOG PS 0-1
Adequate organ function

Exclusion Criteria

Exclusion Criteria:

Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition
Active bacterial or viral infections in 2 weeks prior to starting dosing
Symptomatic brain metastases

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    755 participants

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