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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
Date last updated
12/11/2024

Titles & IDs
Public title
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
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
Secondary ID [1] 0 0
BREAKWATER
Secondary ID [2] 0 0
C4221015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Lead-in Study: Incidence of Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
Primary outcome [2] 0 0
Phase 3: Progression free survival, by blinded independent review
Timepoint [2] 0 0
Duration of Phase 3, approximately 36 months
Primary outcome [3] 0 0
Phase 3: Objective response rate by blinded independent review
Timepoint [3] 0 0
Duration of Phase 3, approximately 23 months
Primary outcome [4] 0 0
Cohort 3: Objective response rate by blinded independent review
Timepoint [4] 0 0
Duration of Cohort 3, approximately 15 months.
Secondary outcome [1] 0 0
Safety Lead-in: Incidence of adverse events
Timepoint [1] 0 0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
Secondary outcome [2] 0 0
Safety Lead-in: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
Timepoint [2] 0 0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
Secondary outcome [3] 0 0
Safety Lead-in: Incidence of dose interruptions, dose modifications and discontinuations due to adverse events
Timepoint [3] 0 0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
Secondary outcome [4] 0 0
Safety Lead-in: Overall response rate by investigator
Timepoint [4] 0 0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
Secondary outcome [5] 0 0
Safety Lead-in: Duration of response by Investigator
Timepoint [5] 0 0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
Secondary outcome [6] 0 0
Safety Lead-in:Progression free survival by Investigator
Timepoint [6] 0 0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
Secondary outcome [7] 0 0
Safety Lead-in: Time to response by Investigator
Timepoint [7] 0 0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months
Secondary outcome [8] 0 0
Safety Lead-in: Overall survival
Timepoint [8] 0 0
After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 36 months
Secondary outcome [9] 0 0
Phase 3: Overall survival
Timepoint [9] 0 0
Duration of Phase 3, approximately 50 months
Secondary outcome [10] 0 0
Phase 3: Overall response rate by Investigator and by blinded independent review
Timepoint [10] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [11] 0 0
Phase 3: Duration of response by Investigator and blinded independent review
Timepoint [11] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [12] 0 0
Phase 3: Time to response by blinded independent review and by Investigator
Timepoint [12] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [13] 0 0
Phase 3: Progression free survival by Investigator and by blinded independent review
Timepoint [13] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [14] 0 0
Phase 3: Progression free survival 2 by Investigator
Timepoint [14] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [15] 0 0
Phase 3: Incidence of adverse events
Timepoint [15] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [16] 0 0
Phase 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
Timepoint [16] 0 0
Duration of Phase 3, approximately 36 months
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)
Timepoint [17] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [18] 0 0
Phase 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
Timepoint [18] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [19] 0 0
Phase 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
Timepoint [19] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [20] 0 0
Phase 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
Timepoint [20] 0 0
Duration of Phase 3, approximately 36 months
Secondary outcome [21] 0 0
Phase 3: Confirm the MSI-status in tumor tissue
Timepoint [21] 0 0
Once, pre-treatment
Secondary outcome [22] 0 0
Phase 3: To determine the correlation between ctDNA levels, BRAF V600 alterations, and clinical outcome
Timepoint [22] 0 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.
Secondary outcome [23] 0 0
Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746, irinotecan and SN-38
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
Secondary outcome [24] 0 0
Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
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.
Secondary outcome [25] 0 0
Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
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
Secondary outcome [26] 0 0
Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746 and oxaliplatin
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
Secondary outcome [27] 0 0
Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
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
Secondary outcome [28] 0 0
Safety Lead-in: Clearance of irinotecan, SN-38 and oxaliplatin
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
Secondary outcome [29] 0 0
Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
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
Secondary outcome [30] 0 0
Phase 3: Trough concentrations of encorafenib and its metabolite LHY746
Timepoint [30] 0 0
Predose on Cycle 1 through Cycle 6. Each cycle is 28 days
Secondary outcome [31] 0 0
Cohort 3: Progression free survival by Investigator and by blinded independent review
Timepoint [31] 0 0
Duration of Cohort 3, approximately 21 months
Secondary outcome [32] 0 0
Cohort 3: Overall response rate by investigator
Timepoint [32] 0 0
Duration of Cohort 3, approximately 21 months
Secondary outcome [33] 0 0
Cohort 3: Duration of response by Investigator and by blinded independent review
Timepoint [33] 0 0
Duration of Cohort 3, approximately 21 months
Secondary outcome [34] 0 0
Cohort 3: Time to response by Investigator and by blinded independent review
Timepoint [34] 0 0
Duration of Cohort 3, approximately 21 months
Secondary outcome [35] 0 0
Cohort 3: Overall survival
Timepoint [35] 0 0
Duration of Cohort 3, approximately 36 months
Secondary outcome [36] 0 0
Cohort 3: Incidence of adverse events
Timepoint [36] 0 0
Duration of Cohort 3, approximately 21 months
Secondary outcome [37] 0 0
Cohort 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
Timepoint [37] 0 0
Duration of Cohort 3, approximately 21 months
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)
Timepoint [38] 0 0
Duration of Cohort 3, approximately 21 months
Secondary outcome [39] 0 0
Cohort 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
Timepoint [39] 0 0
Duration of Cohort 3, approximately 21 months
Secondary outcome [40] 0 0
Cohort 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
Timepoint [40] 0 0
Duration of Cohort 3, approximately 21 months
Secondary outcome [41] 0 0
Cohort 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
Timepoint [41] 0 0
Duration of Cohort 3, approximately 21 months
Secondary outcome [42] 0 0
Cohort 3: Confirm the MSI-status in tumor tissue
Timepoint [42] 0 0
Once, pre-treatment
Secondary outcome [43] 0 0
Cohort 3: To determine the correlation between ctDNA levels, BRAF V600 alterations, and clinical outcome
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.
Secondary outcome [44] 0 0
Cohort 3: Trough concentrations of encorafenib and its metabolite LHY746
Timepoint [44] 0 0
Predose on Cycle 1 through Cycle 6. Each cycle is 28 days

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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/12/2026
Actual
Sample size
Target
Accrual to date
Final
808
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Slade Pharmacy - Mount Kuring-Gai
Recruitment hospital [4] 0 0
GenesisCare - North Shore - St Leonards
Recruitment hospital [5] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [6] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [9] 0 0
Monash Health - Clayton
Recruitment hospital [10] 0 0
Austin Health - Heidelberg
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [12] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2080 - Mount Kuring-Gai
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5011 - Adelaide
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Montana
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Argentina
State/province [25] 0 0
Tucumán
Country [26] 0 0
Argentina
State/province [26] 0 0
Ciudad Autónoma de Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Cordoba
Country [28] 0 0
Argentina
State/province [28] 0 0
Córdoba
Country [29] 0 0
Belgium
State/province [29] 0 0
Bruxelles-capitale, Région DE
Country [30] 0 0
Belgium
State/province [30] 0 0
Hainaut
Country [31] 0 0
Belgium
State/province [31] 0 0
Liège
Country [32] 0 0
Belgium
State/province [32] 0 0
West-vlaanderen
Country [33] 0 0
Belgium
State/province [33] 0 0
Antwerpen
Country [34] 0 0
Belgium
State/province [34] 0 0
Leuven
Country [35] 0 0
Brazil
State/province [35] 0 0
RIO Grande DO SUL
Country [36] 0 0
Brazil
State/province [36] 0 0
RJ
Country [37] 0 0
Brazil
State/province [37] 0 0
Santa Catarina
Country [38] 0 0
Brazil
State/province [38] 0 0
SP
Country [39] 0 0
Brazil
State/province [39] 0 0
SÃO Paulo
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Pazardzhik
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Gabrovo
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Plovdiv
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Sofia
Country [44] 0 0
Canada
State/province [44] 0 0
Alberta
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
China
State/province [47] 0 0
Anhui
Country [48] 0 0
China
State/province [48] 0 0
Beijing
Country [49] 0 0
China
State/province [49] 0 0
Chongqing
Country [50] 0 0
China
State/province [50] 0 0
Fujian
Country [51] 0 0
China
State/province [51] 0 0
Guangdong
Country [52] 0 0
China
State/province [52] 0 0
Guangxi
Country [53] 0 0
China
State/province [53] 0 0
Henan
Country [54] 0 0
China
State/province [54] 0 0
Hubei
Country [55] 0 0
China
State/province [55] 0 0
Hunan
Country [56] 0 0
China
State/province [56] 0 0
Jiangsu
Country [57] 0 0
China
State/province [57] 0 0
Liaoning
Country [58] 0 0
China
State/province [58] 0 0
Shandong
Country [59] 0 0
China
State/province [59] 0 0
Shanghai
Country [60] 0 0
China
State/province [60] 0 0
Sichuan
Country [61] 0 0
China
State/province [61] 0 0
Yunnan
Country [62] 0 0
China
State/province [62] 0 0
Zhejiang
Country [63] 0 0
China
State/province [63] 0 0
Nanning
Country [64] 0 0
China
State/province [64] 0 0
Tianjin
Country [65] 0 0
Czechia
State/province [65] 0 0
Brno-mesto
Country [66] 0 0
Czechia
State/province [66] 0 0
Hradec Králové
Country [67] 0 0
Czechia
State/province [67] 0 0
Praha 4
Country [68] 0 0
Czechia
State/province [68] 0 0
Olomouc
Country [69] 0 0
Czechia
State/province [69] 0 0
Praha 5
Country [70] 0 0
Czechia
State/province [70] 0 0
Praha 8
Country [71] 0 0
Denmark
State/province [71] 0 0
Nordjylland
Country [72] 0 0
Denmark
State/province [72] 0 0
Syddanmark
Country [73] 0 0
Denmark
State/province [73] 0 0
Aalborg
Country [74] 0 0
Denmark
State/province [74] 0 0
Copenhagen
Country [75] 0 0
Denmark
State/province [75] 0 0
Herlev
Country [76] 0 0
Denmark
State/province [76] 0 0
Odense C
Country [77] 0 0
Finland
State/province [77] 0 0
Nyland
Country [78] 0 0
Finland
State/province [78] 0 0
Pirkanmaa
Country [79] 0 0
Finland
State/province [79] 0 0
Helsinki
Country [80] 0 0
Finland
State/province [80] 0 0
Oulu
Country [81] 0 0
Finland
State/province [81] 0 0
Pori
Country [82] 0 0
Finland
State/province [82] 0 0
Tampere
Country [83] 0 0
Finland
State/province [83] 0 0
Turku
Country [84] 0 0
Germany
State/province [84] 0 0
Bayern
Country [85] 0 0
Germany
State/province [85] 0 0
Hessen
Country [86] 0 0
Germany
State/province [86] 0 0
Lower Saxony
Country [87] 0 0
Germany
State/province [87] 0 0
Niedersachsen
Country [88] 0 0
Germany
State/province [88] 0 0
Sachsen
Country [89] 0 0
Germany
State/province [89] 0 0
Berlin - Charlottenburg
Country [90] 0 0
Germany
State/province [90] 0 0
Berlin
Country [91] 0 0
Germany
State/province [91] 0 0
Dresden
Country [92] 0 0
Germany
State/province [92] 0 0
Hamburg
Country [93] 0 0
Germany
State/province [93] 0 0
Oldenburg
Country [94] 0 0
India
State/province [94] 0 0
Delhi
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India
State/province [95] 0 0
Maharashtra
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India
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Rajasthan
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Foggia
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Spain
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State/province [171] 0 0
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Country [172] 0 0
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Sweden
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Sweden
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Merck KGaA, Darmstadt, Germany
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Eli Lilly and Company
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04607421
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04607421