NCT03693170|CompletedPhase 2ResultsDMCFDA Drug

Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

ANCHOR-CRC

Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

Pierre Fabre Medicament ClinicalTrials.gov

Compare

1 other identifier

W00090 GE 2 01

Study Type

interventional

Target

Locations

9 countries

Sites

Timeline

RegisteredOct 2018

StartedJan 2019

CompletionApr 2023

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2019

Typical duration for phase_2

Geographic Reach

9 countries

45 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

September 17, 2018

Completed

15 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed

4 months until next milestone

Study Start

First participant enrolled

January 17, 2019

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed

2.2 years until next milestone

Results Posted

Study results publicly available

August 30, 2022

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed

Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

September 17, 2018

Results QC Date

January 13, 2022

Last Update Submit

January 31, 2024

Conditions

BRAF V600E-mutant Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

Confirmed Overall Response Rate (cORR) Based on Local Tumor Assessments
The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
From initiation of treatment to disease progression up to a maximum of 17.6 months.

Secondary Outcomes (16)

Confirmed Overall Response Rate (cORR) Based on Central Tumor Assessment
From initiation of treatment to disease progression up to a maximum of 17.6 months
Overall Response Rate (ORR) Based on Local Tumor Assessments
From initiation of treatment to disease progression up to a maximum of 17.6 months
Overall Response Rate (ORR) Based on Central Tumor Assessments
From initiation of treatment to disease progression up to a maximum of 17.6 months
Duration of Response (DOR) Per Local Assessment
From first radiographic evidence of response to disease progression up to a maximum of 17.6 months
Duration of Response (DOR) Per Central Assessment
From first radiographic evidence of response to disease progression up to a maximum of 17.6 months
+11 more secondary outcomes

Study Arms (1)

1 Arm

EXPERIMENTAL

encorafenib plus binimetinib plus cetuximab

Drug: encorafenibDrug: BinimetinibDrug: Cetuximab

Interventions

encorafenibDRUG

300 mg administered orally once daily (QD)

Also known as: Braftovi

1 Arm

BinimetinibDRUG

Binimetinib 45 mg administered orally twice daily (BID)

Also known as: Mektovi

1 Arm

CetuximabDRUG

Standard of care for the 28 first weeks(\*) and then every 2 weeks (\*\*) : (\*) 400 mg/m2 administered as a 120-min infusion on Cycle 1 Day 1, followed by 250 mg/m2 administered as a 60-min infusion once weekly (QW) for the first 28 weeks. (\*\*) 500 mg/m2 administered as a 120-min infusion twice weekly (Q2W) from Week 29 (Cycle 8 Day 1) onward. Following implementation of an Urgent Safety Measure on 26 Mar 2020 due to the outbreak of COVID-19 pandemic, cetuximab infusions could be administered Q2W regardless of the cycle number, after investigator's evaluation of the benefit/risk ratio for the subject, with regards to COVID-19 pandemic.

Also known as: Erbitux

1 Arm

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female ≥ 18 years of age
Histologically or cytologically confirmed CRC that is metastatic
Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening
Evidence of measurable disease as per RECIST, v1.1
Subject able to receive cetuximab as per approved label with regards to RAS status
Eastern Cooperative Oncology Group Status (ECOG) 0 or 1
Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol
Subject able to take oral medications

You may not qualify if:

Prior systemic therapy for metastatic disease
Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors
Symptomatic brain metastasis or Leptomeningeal disease
History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO
History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose.
Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start
History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment
Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase
Known contraindication to cetuximab administration as per SPC/approved label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pierre Fabre Medicamentlead
Pfizercollaborator
Merck KGaA, Darmstadt, Germanycollaborator
Ono Pharmaceutical Co. Ltdcollaborator

Study Sites (45)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

PC dba West Cancer Center

Germantown, Tennessee, 38138, United States

Location

Krankenhaus der Barmherzigen Brüder

Vienna, 1020, Austria

Location

UZ Gent, Gastro-Enterology

Ghent, East Flanders, 9000, Belgium

Location

Trial DIO, UZ Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

ICM- VAL d 'Aurelle

Montpellier, Cedex 5, 34298, France

Location

Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie

Brest, 29200, France

Location

AP-HM CHU Timone

Marseille, 13005, France

Location

Hôpital Cochin Gastroenterology

Paris, 75014, France

Location

Hôpital Europeen Georges Pompidou

Paris, 75015, France

Location

Hôpital Saint Antoine

Paris, 75571, France

Location

HOPITAL HAUT-LEVEQUE, Av de MAGELLAN

Pessac, 33604, France

Location

ICO- Site René Gauducheau

Saint-Herblain, 44805, France

Location

CHU TOULOUSE Rangueil

Toulouse, France

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

Meldola, Forlì-Cesena, 47014, Italy

Location

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, 10060, Italy

Location

Ospedale Policlinic San Martin

Genova, 16132, Italy

Location

Ospedale S.M. Misericordia

Perugia, 06129, Italy

Location