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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04607421
Registration number
NCT04607421
Ethics application status
Date submitted
5/10/2020
Date registered
29/10/2020
Titles & IDs
Public title
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
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Scientific title
AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER
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Secondary ID [1]
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0
BREAKWATER
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Secondary ID [2]
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0
C4221015
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms
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0
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Condition category
Condition code
Cancer
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0
0
0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Encorafenib
Treatment: Drugs - Cetuximab
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Irinotecan
Treatment: Drugs - Leucovorin
Treatment: Drugs - 5-FU
Treatment: Drugs - Capecitabine
Treatment: Drugs - Bevacizumab
Experimental: Safety Lead-in Cohort 1 - Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks Irinotecan 180 mg/m2 (90-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks
Experimental: Safety Lead-in Cohort 2 - Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120 minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks
Experimental: Phase 3 Arm A - Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks
Experimental: Phase 3 Arm B - Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120 minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks
Active comparator: Phase 3 Arm C - Every two weeks: Oxaliplatin 85 mg/m2 (120-minute IV infusion) Leucovorin 400 mg/m2 (120-minute IV infusion) 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours Bevacizumab (optional; given per prescribing instructions) -OR- Every two weeks: Irinotecan 165 mg/m2 (90-minute IV infusion) Oxaliplatin 85 mg/m2 (120-minute IV infusion) Leucovorin 400 mg/m2 (120-minute IV infusion) 5-FU 2400 or 3200 mg/m2 continuous IV infusion over 46 48 hours Bevacizumab (optional; given per prescribing instructions) -OR- Oxaliplatin 130 mg/m2 (120-minute IV infusion) every 3 weeks Capecitabine 1000 mg/m2 oral tablet twice daily on Days 1-14 Bevacizumab (optional; given per prescribing instructions)
Experimental: Cohort 3 Arm D - Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks Irinotecan 180 mg/m2 (90-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks
Active comparator: Cohort 3 Arm E - Irinotecan 180 mg/m2 (90-minute IV infusion) every 2 weeks, Leucovorin 400 mg/m2 (120-minute IV infusion) every 2 weeks, 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks, Bevacizumab (optional; given per prescribing instructions)
Treatment: Drugs: Encorafenib
75 mg capsules
Treatment: Drugs: Cetuximab
Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial
Treatment: Drugs: Oxaliplatin
Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial
Treatment: Drugs: Irinotecan
Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial
Treatment: Drugs: Leucovorin
Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial
Treatment: Drugs: 5-FU
Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial
Treatment: Drugs: Capecitabine
150 mg or 500 mg Tablet
Treatment: Drugs: Bevacizumab
Optional Injection for intravenous use 100 mg/vial or 400 mg/vial
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety Lead-in Study: Incidence of Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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Incidence of dose limiting toxicity defined as any adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness or concomitant medications/therapies occurring during the first 28 days of treatment
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Timepoint [1]
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After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
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Primary outcome [2]
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Phase 3: Progression free survival, by blinded independent review
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Assessment method [2]
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Progression free survival, defined as the time from the date of randomization to the earliest documented disease progression or death due to any cause: encorafenib and cetuximab + mFOLFOX6 (Arm B) vs the Control Arm (Arm C)
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Timepoint [2]
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0
Duration of Phase 3, approximately 36 months
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Primary outcome [3]
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Phase 3: Objective response rate by blinded independent review
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Assessment method [3]
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Objective response defined as complete response (CR), or partial response (PR) according to RECIST v1.1 based on BICR assessment, from the date of randomization until the date of the first documentation of progression of disease (PD)
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Timepoint [3]
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0
Duration of Phase 3, approximately 23 months
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Primary outcome [4]
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Cohort 3: Objective response rate by blinded independent review
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Assessment method [4]
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Defined as CR, or PR according to RECIST v1.1 based on BICR assessment, from the date of randomization until the date of the first documentation of PD, death or start of new anticancer therapy
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Timepoint [4]
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Duration of Cohort 3, approximately 15 months.
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Secondary outcome [1]
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Safety Lead-in: Incidence of adverse events
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Assessment method [1]
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0
An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship as assessed by CTCAE 4.03
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Timepoint [1]
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After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
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Secondary outcome [2]
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0
Safety Lead-in: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
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Assessment method [2]
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0
Changes in clinical laboratory parameters, vital signs and electrocardiograms determined clinically significant at the investigator's discretion.
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Timepoint [2]
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0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
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Secondary outcome [3]
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0
Safety Lead-in: Incidence of dose interruptions, dose modifications and discontinuations due to adverse events
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Assessment method [3]
0
0
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Timepoint [3]
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0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
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Secondary outcome [4]
0
0
Safety Lead-in: Overall response rate by investigator
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Assessment method [4]
0
0
Overall response rate, defined as the proportion of participants who have achieved a confirmed best overall response per RECIST v1.1: encorafenib and cetuximab + mFOLFOX6 or FOLFIRI
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Timepoint [4]
0
0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
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Secondary outcome [5]
0
0
Safety Lead-in: Duration of response by Investigator
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Assessment method [5]
0
0
Duration of response, defined as the time from the date of first radiographic evidence of response to the earliest documented disease progression per RECIST v1.1, or death due to any cause: encorafenib and cetuximab + mFOLFOX6 or FOLFIRI
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Timepoint [5]
0
0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
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Secondary outcome [6]
0
0
Safety Lead-in:Progression free survival by Investigator
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Assessment method [6]
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0
Progression free survival, defined as the time from the first dose to the earliest documented disease progression per RECIST v1.1, or death due to any cause: encorafenib and cetuximab + mFOLFOX6 or FOLFIRI
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Timepoint [6]
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0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
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Secondary outcome [7]
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0
Safety Lead-in: Time to response by Investigator
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Assessment method [7]
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0
Time to response, defined as the time from first dose to first radiographic evidence of response per RECIST v1.1: encorafenib and cetuximab + mFOLFOX6 or FOLFIRI
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Timepoint [7]
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0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
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Secondary outcome [8]
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0
Safety Lead-in: Overall survival
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Assessment method [8]
0
0
Overall survival defined as the time from the first dose to death due to any cause: encorafenib and cetuximab + mFOLFOX6 or FOLFIRI
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Timepoint [8]
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0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 36 months
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Secondary outcome [9]
0
0
Phase 3: Overall survival
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Assessment method [9]
0
0
Overall survival, defined as the time from the date of randomization to death due to any cause: encorafenib + cetuximab (Arm A) vs Control Arm (Arm C) and encorafenib + cetuximab +mFOLFOX6 (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 (Arm B)
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Timepoint [9]
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0
Duration of Phase 3, approximately 50 months
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Secondary outcome [10]
0
0
Phase 3: Overall response rate by Investigator and by blinded independent review
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Assessment method [10]
0
0
Overall response rate, defined as the proportion of participants who have achieved a confirmed best overall response per RECIST v1.1: encorafenib + cetuximab (Arm A) vs Control Arm (Arm C) and encorafenib + cetuximab +mFOLFOX6 (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 (Arm B)
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Timepoint [10]
0
0
Duration of Phase 3, approximately 36 months
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Secondary outcome [11]
0
0
Phase 3: Duration of response by Investigator and blinded independent review
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Assessment method [11]
0
0
Duration of response, defined as the time from the date of first radiographic evidence of response to the earliest documented disease progression per RECIST v1.1, or death due to any cause: encorafenib + cetuximab (Arm A) vs Control Arm (Arm C) and encorafenib + cetuximab +mFOLFOX6 (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 (Arm B)
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Timepoint [11]
0
0
Duration of Phase 3, approximately 36 months
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Secondary outcome [12]
0
0
Phase 3: Time to response by blinded independent review and by Investigator
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Assessment method [12]
0
0
Time to response, defined as the time from first dose to first radiographic evidence of response per RECIST v1.1: encorafenib + cetuximab (Arm A) vs Control Arm (Arm C) and encorafenib + cetuximab +mFOLFOX6 (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 (Arm B)
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Timepoint [12]
0
0
Duration of Phase 3, approximately 36 months
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Secondary outcome [13]
0
0
Phase 3: Progression free survival by Investigator and by blinded independent review
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Assessment method [13]
0
0
Progression free survival, defined as the time from the first dose to the earliest documented disease progression per RECIST v1.1, or death due to any cause:: encorafenib + cetuximab (Arm A) vs Control Arm (Arm C) and encorafenib + cetuximab +mFOLFOX6 (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 (Arm B)
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Timepoint [13]
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0
Duration of Phase 3, approximately 36 months
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Secondary outcome [14]
0
0
Phase 3: Progression free survival 2 by Investigator
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Assessment method [14]
0
0
Progression free survival 2, defined as the time from the date of randomization to the second objective disease progression per RECIST v1.1, or death from any cause, whichever occurs first: encorafenib + cetuximab (Arm A) vs Control Arm (Arm C) and encorafenib + cetuximab +mFOLFOX6 (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6
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Timepoint [14]
0
0
Duration of Phase 3, approximately 36 months
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Secondary outcome [15]
0
0
Phase 3: Incidence of adverse events
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Assessment method [15]
0
0
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship: encorafenib + cetuximab (Arm A) and encorafenib + cetuximab +mFOLFOX6 (Arm B)
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Timepoint [15]
0
0
Duration of Phase 3, approximately 36 months
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Secondary outcome [16]
0
0
Phase 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
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Assessment method [16]
0
0
Changes in clinical laboratory parameters, vital signs and electrocardiograms determined clinically significant at the investigator's discretion: encorafenib + cetuximab (Arm A) and encorafenib + cetuximab +mFOLFOX6 (Arm B)
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Timepoint [16]
0
0
Duration of Phase 3, approximately 36 months
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Secondary outcome [17]
0
0
Phase 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
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Assessment method [17]
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0
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
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Timepoint [17]
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0
Duration of Phase 3, approximately 36 months
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Secondary outcome [18]
0
0
Phase 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
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Assessment method [18]
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0
The EQ-5D-5L is a standardized measure of health utility that provides a single index value for the participant's health status. It is frequently used for economic evaluations of health care and has been shown to be a valid and reliable instrument, and comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding, taking about 2 minutes to complete
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Timepoint [18]
0
0
Duration of Phase 3, approximately 36 months
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Secondary outcome [19]
0
0
Phase 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
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Assessment method [19]
0
0
The PGIS is a single-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time.
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Timepoint [19]
0
0
Duration of Phase 3, approximately 36 months
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Secondary outcome [20]
0
0
Phase 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
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Assessment method [20]
0
0
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in symptoms or quality of life since starting treatment.
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Timepoint [20]
0
0
Duration of Phase 3, approximately 36 months
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Secondary outcome [21]
0
0
Phase 3: Confirm the MSI-status in tumor tissue
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Assessment method [21]
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0
Summarize MSI-status as determined by retrospective central testing of baseline tumor tissue
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Timepoint [21]
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Once, pre-treatment
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Secondary outcome [22]
0
0
Phase 3: To determine the correlation between ctDNA levels, BRAF V600 alterations, and clinical outcome
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Assessment method [22]
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0
ctDNA levels and BRAF V600 VAF from ctDNA analysis of plasma samples collected at baseline and on treatment
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Timepoint [22]
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0
Predose on Cycle 1 Day 1, 15, Cycle 2 Day 15, Cycle 7 Day 1 and EOT. Arm C sampling on Day 1 of Cycles 1-3, 9 and EOT. EOT is approx 36 months.
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Secondary outcome [23]
0
0
Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746, irinotecan and SN-38
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Assessment method [23]
0
0
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Timepoint [23]
0
0
Cycle 1 Day 1 and Day 15: predose, and 0.75, 1.5, 2.5, 3.5, 5.5 and 7.5 hours after dosing, Cycle 1 Day 3 and Day 17:predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
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Secondary outcome [24]
0
0
Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
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Assessment method [24]
0
0
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Timepoint [24]
0
0
Cycle 1 Day 1 and Day 15: predose, and 0.75, 1.5, 2.5, 3.5, 5.5 and 7.5 hours after dosing, Cycle 1 Day 3 and Day 17:predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days.
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Secondary outcome [25]
0
0
Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
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Assessment method [25]
0
0
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Timepoint [25]
0
0
Cycle 1 Day 1 and Day 15: predose, and 0.75, 1.5, 2.5, 3.5, 5.5 and 7.5 hours after dosing, Cycle 1 Day 3 and Day 17:predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
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Secondary outcome [26]
0
0
Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746 and oxaliplatin
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Assessment method [26]
0
0
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Timepoint [26]
0
0
Cycle 1 Day 1 and Day 15: predose, and 1, 2, 3, 4, 6 and 8 hours after dosing, Cycle 1 Day 3 and Day 17: predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
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Secondary outcome [27]
0
0
Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
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Assessment method [27]
0
0
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Timepoint [27]
0
0
Cycle 1 Day 1 and Day 15: predose, and 1, 2, 3, 4, 6 and 8 hours after dosing, Cycle 1 Day 3 and Day 17: predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
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Secondary outcome [28]
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0
Safety Lead-in: Clearance of irinotecan, SN-38 and oxaliplatin
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Assessment method [28]
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Changes in exposures of irinotecan and its metabolite (SN-38) on Cycle 1 Day 15 compared to Cycle 1 Day 1 in Cohort 1 (encorafenib and cetuximab + FOLFIRI) Changes in exposures of oxaliplatin on Cycle 1 Day 15 compared to Cycle 1 Day 1 in Cohort 2 (encorafenib and cetuximab + mFOLFOX6)
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Timepoint [28]
0
0
Cycle 1 Day 1 and Day 15: predose, and 0.75, 1.5, 2.5, 3.5, 5.5 and 7.5 hours after dosing, Cycle 1 Day 3 and Day 17:predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
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Secondary outcome [29]
0
0
Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
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Assessment method [29]
0
0
Query!
Timepoint [29]
0
0
Cycle 1 Day 1 and Day 15: predose, and 1, 2, 3, 4, 6 and 8 hours after dosing, Cycle 1 Day 3 and Day 17: predose and Cycle 2 through Cycle 6: Day 1 predose. Each cycle is 28 days
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Secondary outcome [30]
0
0
Phase 3: Trough concentrations of encorafenib and its metabolite LHY746
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Assessment method [30]
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0
Trough plasma concentrations in all patients in Arm A and Arm B
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Timepoint [30]
0
0
Predose on Cycle 1 through Cycle 6. Each cycle is 28 days
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Secondary outcome [31]
0
0
Cohort 3: Progression free survival by Investigator and by blinded independent review
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Assessment method [31]
0
0
Progression free survival, defined as the time from the first dose to the earliest documented disease progression per RECIST v1.1, or death due to any cause.
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Timepoint [31]
0
0
Duration of Cohort 3, approximately 21 months
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Secondary outcome [32]
0
0
Cohort 3: Overall response rate by investigator
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Assessment method [32]
0
0
Overall response rate, defined as the proportion of participants who have achieved a confirmed best overall response per RECIST v 1.1
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Timepoint [32]
0
0
Duration of Cohort 3, approximately 21 months
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Secondary outcome [33]
0
0
Cohort 3: Duration of response by Investigator and by blinded independent review
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Assessment method [33]
0
0
Duration of response, defined as the time from the date of first radiographic evidence of response to the earliest documented disease progression per RECIST v1.1, or death due to any cause
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Timepoint [33]
0
0
Duration of Cohort 3, approximately 21 months
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Secondary outcome [34]
0
0
Cohort 3: Time to response by Investigator and by blinded independent review
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Assessment method [34]
0
0
Time to response, defined as the time from the date of randomization to first radiographic evidence of response per RECIST v1.1
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Timepoint [34]
0
0
Duration of Cohort 3, approximately 21 months
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Secondary outcome [35]
0
0
Cohort 3: Overall survival
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Assessment method [35]
0
0
Overall survival, defined as the time from the date of randomization to death due to any cause
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Timepoint [35]
0
0
Duration of Cohort 3, approximately 36 months
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Secondary outcome [36]
0
0
Cohort 3: Incidence of adverse events
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Assessment method [36]
0
0
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship: encorafenib + cetuximab (Arm A) and encorafenib + cetuximab +mFOLFOX6 (Arm B)
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Timepoint [36]
0
0
Duration of Cohort 3, approximately 21 months
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Secondary outcome [37]
0
0
Cohort 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
Query!
Assessment method [37]
0
0
Changes in clinical laboratory parameters, vital signs and electrocardiograms determined clinically significant at the investigator's discretion: encorafenib + cetuximab (Arm A) and encorafenib + cetuximab +mFOLFOX6 (Arm B)
Query!
Timepoint [37]
0
0
Duration of Cohort 3, approximately 21 months
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Secondary outcome [38]
0
0
Cohort 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Query!
Assessment method [38]
0
0
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Query!
Timepoint [38]
0
0
Duration of Cohort 3, approximately 21 months
Query!
Secondary outcome [39]
0
0
Cohort 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
Query!
Assessment method [39]
0
0
The EQ-5D-5L is a standardized measure of health utility that provides a single index value for the participant's health status. It is frequently used for economic evaluations of health care and has been shown to be a valid and reliable instrument, and comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding, taking about 2 minutes to complete
Query!
Timepoint [39]
0
0
Duration of Cohort 3, approximately 21 months
Query!
Secondary outcome [40]
0
0
Cohort 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
Query!
Assessment method [40]
0
0
The PGIS is a single-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time.
Query!
Timepoint [40]
0
0
Duration of Cohort 3, approximately 21 months
Query!
Secondary outcome [41]
0
0
Cohort 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
Query!
Assessment method [41]
0
0
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change in symptoms or quality of life since starting treatment.
Query!
Timepoint [41]
0
0
Duration of Cohort 3, approximately 21 months
Query!
Secondary outcome [42]
0
0
Cohort 3: Confirm the MSI-status in tumor tissue
Query!
Assessment method [42]
0
0
Summarize MSI-status as determined by retrospective central testing of baseline tumor tissue
Query!
Timepoint [42]
0
0
Once, pre-treatment
Query!
Secondary outcome [43]
0
0
Cohort 3: To determine the correlation between ctDNA levels, BRAF V600 alterations, and clinical outcome
Query!
Assessment method [43]
0
0
ctDNA levels and BRAF V600 VAF from ctDNA analysis of plasma samples collected at baseline and on treatment
Query!
Timepoint [43]
0
0
Predose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 15, Cycle 7 Day 1 and End of Treatment (Duration of Cohort 3, approximately 21 months). Each cycle is 28 days.
Query!
Secondary outcome [44]
0
0
Cohort 3: Trough concentrations of encorafenib and its metabolite LHY746
Query!
Assessment method [44]
0
0
Trough plasma concentrations in all patients in Arm D
Query!
Timepoint [44]
0
0
Predose on Cycle 1 through Cycle 6. Each cycle is 28 days
Query!
Eligibility
Key inclusion criteria
* Safety Lead-In = Male/female = 18 years old
* Phase 3 and Cohort 3: Male/female = 16 years old (where permitted locally)
* Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
* Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment )
* Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in)
* ECOG PS 0-1
* Adequate organ function
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition
* Active bacterial or viral infections in 2 weeks prior to starting dosing
* Symptomatic brain metastases
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/12/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
24/12/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
802
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Chris O'Brien Lifehouse - Camperdown
Query!
Recruitment hospital [2]
0
0
Liverpool Hospital - Liverpool
Query!
Recruitment hospital [3]
0
0
Slade Pharmacy - Mount Kuring-Gai
Query!
Recruitment hospital [4]
0
0
GenesisCare - North Shore - St Leonards
Query!
Recruitment hospital [5]
0
0
GenesisCare North Shore - St Leonards
Query!
Recruitment hospital [6]
0
0
Royal Brisbane & Women's Hospital - Herston
Query!
Recruitment hospital [7]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [8]
0
0
The Queen Elizabeth Hospital - Adelaide
Query!
Recruitment hospital [9]
0
0
Monash Health - Clayton
Query!
Recruitment hospital [10]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [11]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [12]
0
0
Alfred Health - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
0
0
2080 - Mount Kuring-Gai
Query!
Recruitment postcode(s) [4]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [5]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [6]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [7]
0
0
5011 - Adelaide
Query!
Recruitment postcode(s) [8]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [9]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [10]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [11]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Louisiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Montana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nebraska
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Jersey
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oklahoma
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oregon
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Pennsylvania
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Tennessee
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Virginia
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Washington
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Wisconsin
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Tucumán
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Ciudad Autónoma de Buenos Aires
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Cordoba
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Córdoba
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Bruxelles-capitale, Région DE
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Hainaut
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Liège
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
West-vlaanderen
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Antwerpen
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Leuven
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
RIO Grande DO SUL
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
RJ
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Santa Catarina
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
SP
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
SÃO Paulo
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Pazardzhik
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Gabrovo
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Plovdiv
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Sofia
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Alberta
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Ontario
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Quebec
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Anhui
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Beijing
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Chongqing
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Fujian
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Guangdong
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Guangxi
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Henan
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Hubei
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Hunan
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Jiangsu
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Liaoning
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Shandong
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Shanghai
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Sichuan
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Yunnan
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Zhejiang
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Nanning
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Tianjin
Query!
Country [65]
0
0
Czechia
Query!
State/province [65]
0
0
Brno-mesto
Query!
Country [66]
0
0
Czechia
Query!
State/province [66]
0
0
Hradec Králové
Query!
Country [67]
0
0
Czechia
Query!
State/province [67]
0
0
Praha 4
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Olomouc
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Praha 5
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Praha 8
Query!
Country [71]
0
0
Denmark
Query!
State/province [71]
0
0
Nordjylland
Query!
Country [72]
0
0
Denmark
Query!
State/province [72]
0
0
Syddanmark
Query!
Country [73]
0
0
Denmark
Query!
State/province [73]
0
0
Aalborg
Query!
Country [74]
0
0
Denmark
Query!
State/province [74]
0
0
Copenhagen
Query!
Country [75]
0
0
Denmark
Query!
State/province [75]
0
0
Herlev
Query!
Country [76]
0
0
Denmark
Query!
State/province [76]
0
0
Odense C
Query!
Country [77]
0
0
Finland
Query!
State/province [77]
0
0
Nyland
Query!
Country [78]
0
0
Finland
Query!
State/province [78]
0
0
Pirkanmaa
Query!
Country [79]
0
0
Finland
Query!
State/province [79]
0
0
Helsinki
Query!
Country [80]
0
0
Finland
Query!
State/province [80]
0
0
Oulu
Query!
Country [81]
0
0
Finland
Query!
State/province [81]
0
0
Pori
Query!
Country [82]
0
0
Finland
Query!
State/province [82]
0
0
Tampere
Query!
Country [83]
0
0
Finland
Query!
State/province [83]
0
0
Turku
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Bayern
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Hessen
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Lower Saxony
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Niedersachsen
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Sachsen
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Berlin - Charlottenburg
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Berlin
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Dresden
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Hamburg
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Oldenburg
Query!
Country [94]
0
0
India
Query!
State/province [94]
0
0
Delhi
Query!
Country [95]
0
0
India
Query!
State/province [95]
0
0
Maharashtra
Query!
Country [96]
0
0
India
Query!
State/province [96]
0
0
Rajasthan
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Cagliari
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Foggia
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Milano
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
Torino
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
Brescia
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
Napoli
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
Padova
Query!
Country [104]
0
0
Italy
Query!
State/province [104]
0
0
Reggio Emilia
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Chiba
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Ehime
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Hokkaido
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Ishikawa
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Kanagawa
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Nagoya, Aichi
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Osaka
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Saitama
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Shizuoka
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Tokyo
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Fukuoka
Query!
Country [116]
0
0
Korea, Republic of
Query!
State/province [116]
0
0
Gyeonggi-do
Query!
Country [117]
0
0
Korea, Republic of
Query!
State/province [117]
0
0
Taegu-kwangyokshi
Query!
Country [118]
0
0
Korea, Republic of
Query!
State/province [118]
0
0
Busan
Query!
Country [119]
0
0
Korea, Republic of
Query!
State/province [119]
0
0
Daegu
Query!
Country [120]
0
0
Korea, Republic of
Query!
State/province [120]
0
0
Incheon
Query!
Country [121]
0
0
Korea, Republic of
Query!
State/province [121]
0
0
Jeonnam
Query!
Country [122]
0
0
Korea, Republic of
Query!
State/province [122]
0
0
Seoul
Query!
Country [123]
0
0
Mexico
Query!
State/province [123]
0
0
Nuevo LEON
Query!
Country [124]
0
0
Mexico
Query!
State/province [124]
0
0
Oaxaca
Query!
Country [125]
0
0
Netherlands
Query!
State/province [125]
0
0
Limburg
Query!
Country [126]
0
0
Netherlands
Query!
State/province [126]
0
0
Noord-brabant
Query!
Country [127]
0
0
Netherlands
Query!
State/province [127]
0
0
Noord-holland
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
Zuid-holland
Query!
Country [129]
0
0
Netherlands
Query!
State/province [129]
0
0
Amsterdam
Query!
Country [130]
0
0
Netherlands
Query!
State/province [130]
0
0
Maastricht
Query!
Country [131]
0
0
Netherlands
Query!
State/province [131]
0
0
Utrecht
Query!
Country [132]
0
0
New Zealand
Query!
State/province [132]
0
0
BAY OF Plenty
Query!
Country [133]
0
0
New Zealand
Query!
State/province [133]
0
0
Auckland
Query!
Country [134]
0
0
Norway
Query!
State/province [134]
0
0
Hordaland
Query!
Country [135]
0
0
Norway
Query!
State/province [135]
0
0
Rogaland
Query!
Country [136]
0
0
Norway
Query!
State/province [136]
0
0
Sør-trøndelag
Query!
Country [137]
0
0
Norway
Query!
State/province [137]
0
0
Vest-agder
Query!
Country [138]
0
0
Norway
Query!
State/province [138]
0
0
Oslo
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Wielkopolskie
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Brzozow
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Bytom
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Gdansk
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Konin
Query!
Country [144]
0
0
Russian Federation
Query!
State/province [144]
0
0
Saint-petersburg
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Country [145]
0
0
Russian Federation
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State/province [145]
0
0
Sankt-peterburg
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Country [146]
0
0
Russian Federation
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State/province [146]
0
0
Chelyabinsk
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Country [147]
0
0
Russian Federation
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State/province [147]
0
0
Kaluga
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Country [148]
0
0
Russian Federation
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State/province [148]
0
0
Moscow
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Country [149]
0
0
Russian Federation
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State/province [149]
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0
Omsk
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Country [150]
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0
Russian Federation
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State/province [150]
0
0
Saint Petersburg
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Country [151]
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0
Russian Federation
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State/province [151]
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0
Saint-Petersburg
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Country [152]
0
0
Russian Federation
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State/province [152]
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0
St. Petersburg
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Country [153]
0
0
Russian Federation
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State/province [153]
0
0
Yaroslavl
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Country [154]
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0
Russian Federation
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State/province [154]
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0
Yaroslav
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Country [155]
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0
Slovakia
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State/province [155]
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0
Banska Bystrica
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Country [156]
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0
Slovakia
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State/province [156]
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0
Bratislava
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Country [157]
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0
Slovakia
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State/province [157]
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0
Kosice
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Country [158]
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0
Slovakia
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State/province [158]
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0
Poprad
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Country [159]
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0
South Africa
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State/province [159]
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0
Cape Town
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Country [160]
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0
South Africa
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State/province [160]
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0
Eastern CAPE
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Country [161]
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0
South Africa
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State/province [161]
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0
Gauteng
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Country [162]
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0
South Africa
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State/province [162]
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0
Western CAPE
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Country [163]
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0
South Africa
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State/province [163]
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0
Johannesburg
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Country [164]
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0
South Africa
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State/province [164]
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Pretoria
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Country [165]
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0
Spain
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State/province [165]
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0
A Coruña
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0
Spain
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State/province [166]
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Alicante
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0
Spain
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Barcelona
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Country [168]
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0
Spain
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State/province [168]
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Madrid
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Country [169]
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Spain
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State/province [169]
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Sevilla
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Spain
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Valencia
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Country [171]
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0
Spain
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State/province [171]
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0
Zaragoza
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Country [172]
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0
Sweden
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State/province [172]
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0
Stockholms LÄN [se-01]
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Country [173]
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Sweden
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State/province [173]
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0
Uppsala LÄN [se-03]
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Country [174]
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0
Sweden
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State/province [174]
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0
Västerbottens LÄN [se-24]
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Country [175]
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0
Sweden
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State/province [175]
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0
Västra Götalands LÄN [se14]
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Country [176]
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0
Taiwan
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State/province [176]
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0
Kaohsiung
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Country [177]
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0
Taiwan
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State/province [177]
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0
Taichung
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Country [178]
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0
Taiwan
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Tainan
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0
Taiwan
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State/province [179]
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0
Taipei
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Country [180]
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0
Taiwan
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State/province [180]
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0
Taoyuan
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Country [181]
0
0
Ukraine
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State/province [181]
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0
KYIV Region, Obuhovskiy District
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Country [182]
0
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Ukraine
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State/province [182]
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0
Dnipro
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Country [183]
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Ukraine
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State/province [183]
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0
Ivano-Frankivsk
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Country [184]
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Ukraine
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State/province [184]
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0
Kharkiv
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Country [185]
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0
Ukraine
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State/province [185]
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0
Kryvyi Rih
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Ukraine
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State/province [186]
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Kyiv
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Country [187]
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0
Ukraine
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State/province [187]
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0
Zaporizhzhia
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Country [188]
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United Kingdom
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State/province [188]
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0
HIGH Heaton
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Country [189]
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0
United Kingdom
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Surrey
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Country [190]
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0
United Kingdom
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State/province [190]
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0
Birmingham
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Country [191]
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0
United Kingdom
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0
London
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Country [192]
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0
United Kingdom
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State/province [192]
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0
Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Ono Pharmaceutical Co. Ltd
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Commercial sector/industry
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Name [2]
0
0
Merck KGaA, Darmstadt, Germany
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Address [2]
0
0
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0
0
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Other collaborator category [3]
0
0
Commercial sector/industry
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Name [3]
0
0
Eli Lilly and Company
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Address [3]
0
0
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Country [3]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone. The study team will monitor how each participant responds to the study treatment for up to about 3 years.
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Trial website
https://clinicaltrials.gov/study/NCT04607421
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
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0
Pfizer
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0
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Phone
0
0
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0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
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Country
0
0
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Phone
0
0
1-800-718-1021
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04607421