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Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer (ANCHOR-CRC)

Primary Purpose

BRAF V600E-mutant Metastatic Colorectal Cancer

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

encorafenib

Binimetinib

Cetuximab

About this trial

This is an interventional treatment trial for BRAF V600E-mutant Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Memorial Sloan Kettering Cancer Center
PC dba West Cancer Center
Krankenhaus der Barmherzigen Brüder
UZ Gent, Gastro-Enterology
Trial DIO, UZ Gasthuisberg
Cliniques universitaires Saint-Luc
ICM- VAL d 'Aurelle
Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie
AP-HM CHU Timone
Hôpital Cochin Gastroenterology
Hôpital Europeen Georges Pompidou
Hôpital Saint Antoine
HOPITAL HAUT-LEVEQUE, Av de MAGELLAN
ICO- Site René Gauducheau
CHU TOULOUSE Rangueil
IRCCS Ospedale Casa Sollievo della Sofferenza
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Ospedale Policlinic San Martin
Ospedale S.M. Misericordia
Pierre Fabre Investigative Site
Pierre Fabre Investigative Site
Pierre Fabre Investigative Site
Pierre Fabre Investigative Site
Pierre Fabre Investigative Site
Pierre Fabre Investigative Site
St Antonius Ziekenhuis
Hospital Puerta de Hierro
Complejo Hospitalario De Navarra S Oncologia Medica
Hospital Vall d'Hebron
Hospital Clínic I Provincial de Barcelona
Institut Català d'Oncologia (ICO L'Hospitalet)
Hospital de la Santa Creu i Santa Pau
Hospital General Universitario Gregorio Marañón
Hospital Universitario HM Sanchinarro
Hospital Clínico Universitario de
Hospital Universitario y Politécnico La FE
Hospital Alvaro Cunqueiro
Hospital Universitario Miguel Servet
Torbay Hospital, Lowes Bridge
The Royal Marsden NHS Foundation Trust
Beatson West of Scotland Cancer Centre
St James Hospital
GI research team, OHCT, Guy's Hospital
GI Research Team, The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1 Arm

Arm Description

encorafenib plus binimetinib plus cetuximab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Confirmed Overall Response Rate (cORR) Based on Central Tumor Assessment

The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by central radiologist 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.

Overall Response Rate (ORR) Based on Local Tumor Assessments

The overall response rate (ORR) is the percentage of 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.

Overall Response Rate (ORR) Based on Central Tumor Assessments

The overall response rate (ORR) is the percentage of responses, defined as complete response (CR) or partial response (PR), as assessed by central radiologist 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.

Duration of Response (DOR) Per Local Assessment

Time from first radiographic evidence of response based on local radiologist/investigator review to the earliest documented PD or death due to underlying disease

Duration of Response (DOR) Per Central Assessment

Time from first radiographic evidence of response based on central review to the earliest documented PD or death due to underlying disease

Time to Response (TTR) Per Local Review

The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per local review

Time to Response (TTR) Per Central Review

The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per central review

Progression-Free Survival (PFS) Per Local Review

Time from first dose to the earliest documented date of disease progression based on local radiologist/investigator review or death due to any cause

Progression of Free Survival (PFS) Per Central Review

Time from first dose to the earliest documented date of disease progression based on central review or death due to any cause

Overall Survival (OS)

Time from first dose to death due to any cause

Plasma Concentration of Encorafenib

Plasma concentration of encorafenib

Plasma Concentration of Binimetinib

Plasma concentration of binimetinib

Plasma Concentration of Cetuximab

Plasma concentration of cetuximab

Change From Baseline in EORTC QLQ-C30 Over Time

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for cancer subjects (EORTC QLQ-C30) includes a global health status/QoL. The scale ranges in score from 0 to 100, higher score on the global health status/QoL scale indicate higher QoL. Changes from baseline in EORTC QLQ-C30 global health status/quality of life (QoL) over time are presented in this record.

Change From Baseline in EQ-5D-5L Over Time

The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L VAS records the patient's self-rated health on a vertical visual analogue scale numbered from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine"). Changes from baseline in EQ-5D-5L VAS over time are presented in this record.

PGIC Scores Over Time

The Patient Global Impression of Change (PGIC) is a measure of patients' perceptions of change in their symptoms over time. For this assessment, subjects answered the following question: "Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse."

Full Information

NCT ID

NCT03693170

First Posted

September 17, 2018

Last Updated

February 24, 2023

Sponsor

Pierre Fabre Medicament

Collaborators

Pfizer, Merck KGaA, Darmstadt, Germany, Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03693170

Brief Title

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

Acronym

ANCHOR-CRC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 17, 2019 (Actual)

Primary Completion Date

June 29, 2020 (Actual)

Study Completion Date

April 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pierre Fabre Medicament

Collaborators

Pfizer, Merck KGaA, Darmstadt, Germany, Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in subjects with mCRC. The preclinical results and preliminary clinical data together justify the evaluation of this triple combination in the first-line setting of this population. The primary objective of the study is to evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the overall response rate in adult subjects with previously untreated BRAFV600E-mutant metastatic colorectal cancer. It will also assess the effect of the triple combination on the duration of response, time to response, progression-free survival and overall survival and assess the effect on quality of life. It will also characterize the safety and tolerability of the triple combination as well as describe the pharmacokinetics (PK) of encorafenib, binimetinib, and cetuximab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

BRAF V600E-mutant Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

All involved know the identity of the intervention assignment.

Allocation

N/A

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Arm

Arm Type

Experimental

Arm Description

encorafenib plus binimetinib plus cetuximab

Intervention Type

Drug

Intervention Name(s)

encorafenib

Other Intervention Name(s)

Braftovi

Intervention Description

300 mg administered orally once daily (QD)

Intervention Type

Drug

Intervention Name(s)

Binimetinib

Other Intervention Name(s)

Mektovi

Intervention Description

Binimetinib 45 mg administered orally twice daily (BID)

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

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.

Primary Outcome Measure Information:

Title

Confirmed Overall Response Rate (cORR) Based on Local Tumor Assessments

Description

Time Frame

From initiation of treatment to disease progression up to a maximum of 17.6 months.

Secondary Outcome Measure Information:

Title

Confirmed Overall Response Rate (cORR) Based on Central Tumor Assessment

Description

Time Frame

From initiation of treatment to disease progression up to a maximum of 17.6 months

Title

Overall Response Rate (ORR) Based on Local Tumor Assessments

Description

Time Frame

From initiation of treatment to disease progression up to a maximum of 17.6 months

Title

Overall Response Rate (ORR) Based on Central Tumor Assessments

Description

Time Frame

From initiation of treatment to disease progression up to a maximum of 17.6 months

Title

Duration of Response (DOR) Per Local Assessment

Description

Time from first radiographic evidence of response based on local radiologist/investigator review to the earliest documented PD or death due to underlying disease

Time Frame

From first radiographic evidence of response to disease progression up to a maximum of 17.6 months

Title

Duration of Response (DOR) Per Central Assessment

Description

Time from first radiographic evidence of response based on central review to the earliest documented PD or death due to underlying disease

Time Frame

From first radiographic evidence of response to disease progression up to a maximum of 17.6 months

Title

Time to Response (TTR) Per Local Review

Description

The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per local review

Time Frame

From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months

Title

Time to Response (TTR) Per Central Review

Description

The TTR is defined as the time from the first dose until the first documented radiographic evidence of response of CR or PR per central review

Time Frame

From initiation of treatment to the first radiographic evidence of response up to a maximum of 17.6 months

Title

Progression-Free Survival (PFS) Per Local Review

Description

Time from first dose to the earliest documented date of disease progression based on local radiologist/investigator review or death due to any cause

Time Frame

From initiation of treatment to disease progression or death up to a maximum of 17.6 months

Title

Progression of Free Survival (PFS) Per Central Review

Description

Time from first dose to the earliest documented date of disease progression based on central review or death due to any cause

Time Frame

From initiation of treatment to disease progression or death up to a maximum of 17.6 months

Title

Overall Survival (OS)

Description

Time from first dose to death due to any cause

Time Frame

From initiation of treatment to death up to a maximum of 17.6 months

Title

Plasma Concentration of Encorafenib

Description

Plasma concentration of encorafenib

Time Frame

2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days)

Title

Plasma Concentration of Binimetinib

Description

Plasma concentration of binimetinib

Time Frame

2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days)

Title

Plasma Concentration of Cetuximab

Description

Plasma concentration of cetuximab

Time Frame

2 hours and 6 hours after dose on Day 1 cycle 1; Predose and 2 hours post dose on Day 1 cycle 2 (cycle length = 28 days)

Title

Change From Baseline in EORTC QLQ-C30 Over Time

Description

Time Frame

From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months

Title

Change From Baseline in EQ-5D-5L Over Time

Description

Time Frame

From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months

Title

PGIC Scores Over Time

Description

Time Frame

From Cycle 1 Day 1 (C1D1) Visit to the 30-day Safety Follow-up Visit up to a maximum of 17.6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabelle KLAUCK, MD

Organizational Affiliation

Corporate Medical&Patient/Consumer Division, Pierre Fabre Medicament

Official's Role

Study Director

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

PC dba West Cancer Center

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Krankenhaus der Barmherzigen Brüder

City

Wien

ZIP/Postal Code

1020

Country

Austria

Facility Name

UZ Gent, Gastro-Enterology

City

Gent

State/Province

East Flanders

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Trial DIO, UZ Gasthuisberg

City

Leuven

State/Province

Flemish Brabant

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Cliniques universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

ICM- VAL d 'Aurelle

City

Montpellier

State/Province

Cedex 5

ZIP/Postal Code

34298

Country

France

Facility Name

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

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

AP-HM CHU Timone

City

Marseille

ZIP/Postal Code

13005

Country

France

Facility Name

Hôpital Cochin Gastroenterology

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Hôpital Europeen Georges Pompidou

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Hôpital Saint Antoine

City

Paris

ZIP/Postal Code

75571

Country

France

Facility Name

HOPITAL HAUT-LEVEQUE, Av de MAGELLAN

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

ICO- Site René Gauducheau

City

Saint-Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

CHU TOULOUSE Rangueil

City

Toulouse

Country

France

Facility Name

IRCCS Ospedale Casa Sollievo della Sofferenza

City

San Giovanni Rotondo

State/Province

Foggia

ZIP/Postal Code

71013

Country

Italy

Facility Name

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

City

Meldola

State/Province

Forlì-Cesena

ZIP/Postal Code

47014

Country

Italy

Facility Name

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

City

Candiolo

ZIP/Postal Code

10060

Country

Italy

Facility Name

Ospedale Policlinic San Martin

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Ospedale S.M. Misericordia

City

Perugia

ZIP/Postal Code

06129

Country

Italy

Facility Name

Pierre Fabre Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Pierre Fabre Investigative Site

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Pierre Fabre Investigative Site

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

Pierre Fabre Investigative Site

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

540-0006

Country

Japan

Facility Name

Pierre Fabre Investigative Site

City

Nagaizumi-cho

State/Province

Shizuoka

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Pierre Fabre Investigative Site

City

Koto-ku,

State/Province

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

St Antonius Ziekenhuis

City

Utrecht

ZIP/Postal Code

3543 AZ

Country

Netherlands

Facility Name

Hospital Puerta de Hierro

City

Madrid

State/Province

Community Of Madrid

ZIP/Postal Code

28220

Country

Spain

Facility Name

Complejo Hospitalario De Navarra S Oncologia Medica

City

Pamplona

State/Province

Navarre

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hospital Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clínic I Provincial de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Institut Català d'Oncologia (ICO L'Hospitalet)

City

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Hospital de la Santa Creu i Santa Pau

City

Barcelona

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañón

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Hospital Universitario HM Sanchinarro

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Clínico Universitario de

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Hospital Universitario y Politécnico La FE

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Hospital Alvaro Cunqueiro

City

Vigo

ZIP/Postal Code

36312

Country

Spain

Facility Name

Hospital Universitario Miguel Servet

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Torbay Hospital, Lowes Bridge

City

Torquay

State/Province

Devon

ZIP/Postal Code

TQ2 7AA

Country

United Kingdom

Facility Name

The Royal Marsden NHS Foundation Trust

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Beatson West of Scotland Cancer Centre

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

St James Hospital

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

GI research team, OHCT, Guy's Hospital

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

GI Research Team, The Christie NHS Foundation Trust

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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