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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.

NCT05004350 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2026-04-30

Study results available
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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.

Conditions

Interventions

DRUG

Encorafenib

oral hard capsule

DRUG

Cetuximab

intravenous infusion

DRUG

FOLFIRI

Combination of: irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous infusion, and 5-FU (also known as; fluorouracil) intravenous bolus/intravenous infusion

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Shen Lin, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2023-12-19
Completion
2024-12-07

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05004350 on ClinicalTrials.gov