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Kinase Inhibitor

Encorafenib for Colorectal Cancer (BEACON CRC Trial)

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,cycle (c)1 day (d)1, c2 d1, c3 d1, c4 d1, c5 d1, c6 d1, c7 d1, c8 d1, c9 d1, c10 d1, c11 d1, c12 d1, c13 d1, c14 d1, c15 d1, c16 d1, c17 d1, c18 d1, c19 d1, c20 d1, c21 d1, c22 d1, c23 d1, end of treatment, 30 day follow up(each cycle of 28 days)

Awards & highlights

BEACON CRC Trial Summary

This trial is testing a new combination of drugs for people with metastatic colorectal cancer that has progressed after 1-2 other treatments. The new combination includes encorafenib, cetuximab, and binimetinib, versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab (controls). The study will first assess the safety and tolerability of the new combination in a Safety Lead-in Phase.

Eligible Conditions

Colorectal Cancer

BEACON CRC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, cycle(c)1 day(d)1 , c2 d1, c3 d1, c4 d1, c5 d1, c6 d1, c7 d1, c8 d1, c9 d1, c10 d1, c11 d1, c12 d1, c13 d1, c14 d1, c15 d1, c16 d1, c17 d1, c18 d1, c19 d1, c20 d1, c21 d1, c22 d1, c23 d1, end of treatment, 30 day follow up(each cycle of 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, cycle(c)1 day(d)1 , c2 d1, c3 d1, c4 d1, c5 d1, c6 d1, c7 d1, c8 d1, c9 d1, c10 d1, c11 d1, c12 d1, c13 d1, c14 d1, c15 d1, c16 d1, c17 d1, c18 d1, c19 d1, c20 d1, c21 d1, c22 d1, c23 d1, end of treatment, 30 day follow up(each cycle of 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, cycle(c)1 day(d)1 , c2 d1, c3 d1, c4 d1, c5 d1, c6 d1, c7 d1, c8 d1, c9 d1, c10 d1, c11 d1, c12 d1, c13 d1, c14 d1, c15 d1, c16 d1, c17 d1, c18 d1, c19 d1, c20 d1, c21 d1, c22 d1, c23 d1, end of treatment, 30 day follow up(each cycle of 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

(Phase 3) Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm

(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis

(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis

+3 more

Secondary outcome measures

(Phase 3) Change From Baseline in the EuroQol-5D-5L Visual Analog Scale (EQ-5D-5L VAS) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

(Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Participants (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

Malignant Neoplasms

+60 more

Other outcome measures

(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis

BEACON CRC Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Safety Lead-in, Triplet ArmExperimental Treatment3 Interventions

Encorafenib + binimetinib + cetuximab.

Group II: Doublet ArmExperimental Treatment2 Interventions

Encorafenib + cetuximab.

Group III: Control ArmActive Control4 Interventions

Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Encorafenib

2021

Completed Phase 3

~960

Binimetinib

2018

Completed Phase 3

~1100

Cetuximab

2011

Completed Phase 3

~2480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,283 Total Patients Enrolled

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

113,954 Total Patients Enrolled

Pierre Fabre MedicamentIndustry Sponsor

74 Previous Clinical Trials

18,210 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other studies that have been done using Encorafenib?

"Encorafenib was first researched two decades ago at Wellington Hospital. So far, 1327 different clinical trials have been completed while 687 are still ongoing. Many of these active studies are based in Saint Louis, Missouri."

Answered by AI

Could you disclose how many medical facilities are taking part in this clinical trial?

"So far, 96 patients have enrolled at locations like SSM Health Saint Louis University Hospital, Oregon Health and Science University, Norris Healthcare Center 3, and other 96 sites."

Answered by AI

Are there risks associated with taking Encorafenib?

"Encorafenib's safety has been studied multiple times and it has been shown to be effective, so it has been given a score of 3."

Answered by AI

How many research participants are in this clinical trial?

"This study is not recruiting at this moment. It was originally posted on October 13th, 2016 but was last updated on November 2nd, 2022. If the individual is searching for other studies, there are 891 studies for colorectal carcinoma and 687 studies for Encorafenib that are currently admitting patients."

Answered by AI

What are Encorafenib's most common indications?

"Encorafenib is an effective treatment for macrocytic anemia, malignant neoplasms, and bladder cancer."

Answered by AI

Are patients being actively enrolled in this clinical trial at this time?

"According to clinicaltrials.gov, this particular trial is no longer recruiting patients. Although the last update was on November 2nd, 2022, the trial originally posted on October 13th, 2016. There are 1578 other trials that are still recruiting patients."

Answered by AI

Recent research and studies

brafJournal

Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated braf V600e–mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study

Tabernero, Josep, Axel Grothey, Eric Van Cutsem, Rona Yaeger, Harpreet Wasan, Takayuki Yoshino, Jayesh Desai, et al.. 2021. “Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated braf V600e–mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.02088.

brafJournal

Encorafenib, Binimetinib, and Cetuximab in braf V600e–mutated Colorectal Cancer

Kopetz, Scott, Axel Grothey, Rona Yaeger, Eric Van Cutsem, Jayesh Desai, Takayuki Yoshino, Harpreet Wasan, et al.. 2019. “Encorafenib, Binimetinib, and Cetuximab in braf V600e–mutated Colorectal Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1908075.

brafJournal

Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients with braf V600e–mutant Metastatic Colorectal Cancer: Safety Lead-in Results from the Phase III BEACON Colorectal Cancer Study

Van Cutsem, Eric, Sanne Huijberts, Axel Grothey, Rona Yaeger, Pieter-Jan Cuyle, Elena Elez, Marwan Fakih, et al.. 2019. “Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients with braf V600e–mutant Metastatic Colorectal Cancer: Safety Lead-in Results from the Phase III BEACON Colorectal Cancer Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.18.02459.

Clinical Colorectal CancerJournal