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A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.

A Multicenter, Randomized, Open-label, 2-arm, Phase II Study With a Safety lead-in Phase Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.

NCT05004350•Pierre Fabre Medicament

View on ClinicalTrials.gov

Summary

Encorafenib is currently being developed (with or without binimetinib), in combination with cetuximab, for the treatment of adult patients with B-RAF proto-oncogene, serine/threonine kinase V600E mutant (BRAF V600E) metastatic colorectal cancer (mCRC), who have received prior systemic therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chinese male or female participant with age ≥18 years at the time of informed consent.
•Histologically- or cytologically-confirmed colorectal cancer (CRC) that is metastatic.
•Eligible to receive cetuximab per Chinese approved label with regard to tumor Rat Sarcoma Viral Oncogene Homologue (RAS) mutation status (i.e. approved for Rat Sarcoma Viral Oncogene Homologue Wild Type(RAS wt) status).
•Able to provide a sufficient amount of representative tumor specimen for central prospective laboratory testing of B-RAF Proto-oncogene, Serine/threonine Kinase (BRAF) mutation status and also retrospective RAS wt status and Microsatellite Instability (MSI) testing.
•Chinese male or female participant with age ≥18 years at time of informed consent.
•Histologically or cytologically confirmed CRC that is metastatic and unresectable at time of study entry (i.e. not suitable for complete surgical resection at screening).
•Presence of a BRAF V600E mutation in tumor tissue previously determined by a local assay at any time before screening or by the central laboratory.

Exclusion Criteria

•Prior anti-Epidermal Growth Factor Receptor (anti-EGFR) treatment
•More than two prior regimens in the metastatic setting.
•Known contraindication to receive cetuximab or irinotecan at the planned dose according to the most recent cetuximab and irinotecan local label.
•Known history of Gilbert's syndrome or is known to have any of the following genotypes: uridine 5'-diphospho-glucuronosyltransferase (UGT)1A1\*6/\*6, UGT1A1\*28/\*28 or UGT1A1\*6/\*28.
•Leptomeningeal disease.
•Prior treatment with any Proto oncogene Serine/threonine-Protein Kinase (RAF) inhibitor, cetuximab, panitumumab or other EGFR inhibitors.
•Symptomatic brain metastasis.
•Leptomeningeal disease.
•Use of any herbal medications/supplements or any medications or foods that are moderate or strong inhibitors or inducers of cytochrome P450 (CYP)3A4/5 ≤1 week before the start of study intervention.
•Known history of acute or chronic pancreatitis within 6 months before the start of study intervention.

Locations (34)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Medical University - Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital Sun Yat-Sen University

Guangzhou, Guangdong, China

Cancer Hospital Affiliated to Shantou University Medical College

Shantou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The Affiliated Hospital of Hebei University

Baoding, Hebei, China

Key Dates

Start Date

September 14, 2021

Primary Completion Date

December 19, 2023

Completion Date

December 7, 2024

Last Updated

April 15, 2025

Enrollment

107

ACTUAL participants

Conditions

BRAF V600EMetastatic Colorectal Cancer

Interventions

Encorafenib

DRUG

Cetuximab

DRUG

FOLFIRI

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.

Inclusion Criteria

Exclusion Criteria

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