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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
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
Country [95] 0 0
India
State/province [95] 0 0
Maharashtra
Country [96] 0 0
India
State/province [96] 0 0
Rajasthan
Country [97] 0 0
Italy
State/province [97] 0 0
Cagliari
Country [98] 0 0
Italy
State/province [98] 0 0
Foggia
Country [99] 0 0
Italy
State/province [99] 0 0
Milano
Country [100] 0 0
Italy
State/province [100] 0 0
Torino
Country [101] 0 0
Italy
State/province [101] 0 0
Brescia
Country [102] 0 0
Italy
State/province [102] 0 0
Napoli
Country [103] 0 0
Italy
State/province [103] 0 0
Padova
Country [104] 0 0
Italy
State/province [104] 0 0
Reggio Emilia
Country [105] 0 0
Japan
State/province [105] 0 0
Chiba
Country [106] 0 0
Japan
State/province [106] 0 0
Ehime
Country [107] 0 0
Japan
State/province [107] 0 0
Hokkaido
Country [108] 0 0
Japan
State/province [108] 0 0
Ishikawa
Country [109] 0 0
Japan
State/province [109] 0 0
Kanagawa
Country [110] 0 0
Japan
State/province [110] 0 0
Nagoya, Aichi
Country [111] 0 0
Japan
State/province [111] 0 0
Osaka
Country [112] 0 0
Japan
State/province [112] 0 0
Saitama
Country [113] 0 0
Japan
State/province [113] 0 0
Shizuoka
Country [114] 0 0
Japan
State/province [114] 0 0
Tokyo
Country [115] 0 0
Japan
State/province [115] 0 0
Fukuoka
Country [116] 0 0
Korea, Republic of
State/province [116] 0 0
Gyeonggi-do
Country [117] 0 0
Korea, Republic of
State/province [117] 0 0
Taegu-kwangyokshi
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Busan
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Daegu
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Incheon
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Jeonnam
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Seoul
Country [123] 0 0
Mexico
State/province [123] 0 0
Nuevo LEON
Country [124] 0 0
Mexico
State/province [124] 0 0
Oaxaca
Country [125] 0 0
Netherlands
State/province [125] 0 0
Limburg
Country [126] 0 0
Netherlands
State/province [126] 0 0
Noord-brabant
Country [127] 0 0
Netherlands
State/province [127] 0 0
Noord-holland
Country [128] 0 0
Netherlands
State/province [128] 0 0
Zuid-holland
Country [129] 0 0
Netherlands
State/province [129] 0 0
Amsterdam
Country [130] 0 0
Netherlands
State/province [130] 0 0
Maastricht
Country [131] 0 0
Netherlands
State/province [131] 0 0
Utrecht
Country [132] 0 0
New Zealand
State/province [132] 0 0
BAY OF Plenty
Country [133] 0 0
New Zealand
State/province [133] 0 0
Auckland
Country [134] 0 0
Norway
State/province [134] 0 0
Hordaland
Country [135] 0 0
Norway
State/province [135] 0 0
Rogaland
Country [136] 0 0
Norway
State/province [136] 0 0
Sør-trøndelag
Country [137] 0 0
Norway
State/province [137] 0 0
Vest-agder
Country [138] 0 0
Norway
State/province [138] 0 0
Oslo
Country [139] 0 0
Poland
State/province [139] 0 0
Wielkopolskie
Country [140] 0 0
Poland
State/province [140] 0 0
Brzozow
Country [141] 0 0
Poland
State/province [141] 0 0
Bytom
Country [142] 0 0
Poland
State/province [142] 0 0
Gdansk
Country [143] 0 0
Poland
State/province [143] 0 0
Konin
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Saint-petersburg
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Sankt-peterburg
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Chelyabinsk
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Kaluga
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Moscow
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Omsk
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Saint Petersburg
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Saint-Petersburg
Country [152] 0 0
Russian Federation
State/province [152] 0 0
St. Petersburg
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Yaroslavl
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Yaroslav
Country [155] 0 0
Slovakia
State/province [155] 0 0
Banska Bystrica
Country [156] 0 0
Slovakia
State/province [156] 0 0
Bratislava
Country [157] 0 0
Slovakia
State/province [157] 0 0
Kosice
Country [158] 0 0
Slovakia
State/province [158] 0 0
Poprad
Country [159] 0 0
South Africa
State/province [159] 0 0
Cape Town
Country [160] 0 0
South Africa
State/province [160] 0 0
Eastern CAPE
Country [161] 0 0
South Africa
State/province [161] 0 0
Gauteng
Country [162] 0 0
South Africa
State/province [162] 0 0
Western CAPE
Country [163] 0 0
South Africa
State/province [163] 0 0
Johannesburg
Country [164] 0 0
South Africa
State/province [164] 0 0
Pretoria
Country [165] 0 0
Spain
State/province [165] 0 0
A Coruña
Country [166] 0 0
Spain
State/province [166] 0 0
Alicante
Country [167] 0 0
Spain
State/province [167] 0 0
Barcelona
Country [168] 0 0
Spain
State/province [168] 0 0
Madrid
Country [169] 0 0
Spain
State/province [169] 0 0
Sevilla
Country [170] 0 0
Spain
State/province [170] 0 0
Valencia
Country [171] 0 0
Spain
State/province [171] 0 0
Zaragoza
Country [172] 0 0
Sweden
State/province [172] 0 0
Stockholms LÄN [se-01]
Country [173] 0 0
Sweden
State/province [173] 0 0
Uppsala LÄN [se-03]
Country [174] 0 0
Sweden
State/province [174] 0 0
Västerbottens LÄN [se-24]
Country [175] 0 0
Sweden
State/province [175] 0 0
Västra Götalands LÄN [se14]
Country [176] 0 0
Taiwan
State/province [176] 0 0
Kaohsiung
Country [177] 0 0
Taiwan
State/province [177] 0 0
Taichung
Country [178] 0 0
Taiwan
State/province [178] 0 0
Tainan
Country [179] 0 0
Taiwan
State/province [179] 0 0
Taipei
Country [180] 0 0
Taiwan
State/province [180] 0 0
Taoyuan
Country [181] 0 0
Ukraine
State/province [181] 0 0
KYIV Region, Obuhovskiy District
Country [182] 0 0
Ukraine
State/province [182] 0 0
Dnipro
Country [183] 0 0
Ukraine
State/province [183] 0 0
Ivano-Frankivsk
Country [184] 0 0
Ukraine
State/province [184] 0 0
Kharkiv
Country [185] 0 0
Ukraine
State/province [185] 0 0
Kryvyi Rih
Country [186] 0 0
Ukraine
State/province [186] 0 0
Kyiv
Country [187] 0 0
Ukraine
State/province [187] 0 0
Zaporizhzhia
Country [188] 0 0
United Kingdom
State/province [188] 0 0
HIGH Heaton
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Surrey
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Birmingham
Country [191] 0 0
United Kingdom
State/province [191] 0 0
London
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Oxford

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
Trial website
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
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


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