A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified July 2025 by Pfizer
Sponsor
Pfizer
Information Provided by (Responsible Party)
Pfizer
Clinicaltrials.gov Identifier
NCT04607421
Other Study ID Numbers:
C4221015
First Submitted
October 4, 2020
First Posted
October 28, 2020
Last Update Posted
August 13, 2025
Last Verified
July 2025

ClinicalTrials.gov processed this data on August 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC. Since encorafenib has not previously been combined with chemotherapy, the tolerability and PK of EC in combination with mFOLFOX6 and in combination with FOLFIRI will be evaluated in separate cohorts in the safety lead-in portion of the trial in order to identify which chemotherapy combination is to be used in the Phase 3 portion of the study.

Condition or DiseaseIntervention/Treatment
Neoplasms
Drug: EncorafenibDrug: EncorafenibDrug: EncorafenibDrug: EncorafenibDrug: OxaliplatinDrug: EncorafenibDrug: Irinotecan

Study Design

Study TypeInterventional
Actual Enrollment831 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAN 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
Study Start DateDecember 20, 2020
Actual Primary Completion DateDecember 7, 2025
Actual Study Completion Date1yr 7mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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
Drug: Encorafenib
75 mg capsules
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
Drug: Encorafenib
75 mg capsules
Phase 3 Arm A
Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks
Drug: Encorafenib
75 mg capsules
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
Drug: Encorafenib
75 mg capsules
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)
Drug: Oxaliplatin
Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial
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
Drug: Encorafenib
75 mg capsules
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)
Drug: Irinotecan
Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial

Outcome Measures

Primary Outcome Measures
  1. Safety Lead-in Study: Incidence of Dose Limiting Toxicities (DLTs)
    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
  2. Phase 3: Progression free survival, by blinded independent review
    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)
  3. Phase 3: Objective response rate by blinded independent review
    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)
  4. Cohort 3: Objective response rate by blinded independent review
    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
Secondary Outcome Measures
  1. Safety Lead-in: Incidence of adverse events
    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
  2. Safety Lead-in: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
    Changes in clinical laboratory parameters, vital signs and electrocardiograms determined clinically significant at the investigator's discretion.
  3. Safety Lead-in: Incidence of dose interruptions, dose modifications and discontinuations due to adverse events
  4. Safety Lead-in: Overall response rate by investigator
    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
  5. Safety Lead-in: Duration of response by Investigator
    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
  6. Safety Lead-in:Progression free survival by Investigator
    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
  7. Safety Lead-in: Time to response by Investigator
    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
  8. Safety Lead-in: Overall survival
    Overall survival defined as the time from the first dose to death due to any cause: encorafenib and cetuximab + mFOLFOX6 or FOLFIRI
  9. Phase 3: Overall survival
    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)
  10. Phase 3: Overall response rate by Investigator and by blinded independent review
    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)
  11. Phase 3: Duration of response by Investigator and blinded independent review
    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)
  12. Phase 3: Time to response by blinded independent review and by Investigator
    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)
  13. Phase 3: Progression free survival by Investigator and by blinded independent review
    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)
  14. Phase 3: Progression free survival 2 by Investigator
    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
  15. Phase 3: Incidence of adverse events
    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)
  16. Phase 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
    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)
  17. Phase 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
    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.
  18. Phase 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
    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
  19. Phase 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
    The PGIS is a single-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time.
  20. Phase 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
    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.
  21. Phase 3: Confirm the MSI-status in tumor tissue
    Summarize MSI-status as determined by retrospective central testing of baseline tumor tissue
  22. Phase 3: To determine the correlation between ctDNA levels, BRAF V600 alterations, and clinical outcome
    ctDNA levels and BRAF V600 VAF from ctDNA analysis of plasma samples collected at baseline and on treatment
  23. Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746, irinotecan and SN-38
  24. Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
  25. Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
  26. Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746 and oxaliplatin
  27. Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
  28. Safety Lead-in: Clearance of irinotecan, SN-38 and oxaliplatin
    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)
  29. Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
  30. Phase 3: Trough concentrations of encorafenib and its metabolite LHY746
    Trough plasma concentrations in all patients in Arm A and Arm B
  31. Cohort 3: Progression free survival by Investigator and by blinded independent review
    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.
  32. Cohort 3: Overall response rate by investigator
    Overall response rate, defined as the proportion of participants who have achieved a confirmed best overall response per RECIST v 1.1
  33. Cohort 3: Duration of response by Investigator and by blinded independent review
    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
  34. Cohort 3: Time to response by Investigator and by blinded independent review
    Time to response, defined as the time from the date of randomization to first radiographic evidence of response per RECIST v1.1
  35. Cohort 3: Overall survival
    Overall survival, defined as the time from the date of randomization to death due to any cause
  36. Cohort 3: Incidence of adverse events
    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)
  37. Cohort 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
    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)
  38. Cohort 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
    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.
  39. Cohort 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
    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
  40. Cohort 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
    The PGIS is a single-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time.
  41. Cohort 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
    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.
  42. Cohort 3: Confirm the MSI-status in tumor tissue
    Summarize MSI-status as determined by retrospective central testing of baseline tumor tissue
  43. Cohort 3: To determine the correlation between ctDNA levels, BRAF V600 alterations, and clinical outcome
    ctDNA levels and BRAF V600 VAF from ctDNA analysis of plasma samples collected at baseline and on treatment
  44. Cohort 3: Trough concentrations of encorafenib and its metabolite LHY746
    Trough plasma concentrations in all patients in Arm D

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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
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

Contacts and Locations

Sponsors and CollaboratorsPfizer
Locations
Mayo Clinic Hospital | Phoenix Arizona, United States, 85054Mayo Clinic in Arizona - Scottsdale | Scottsdale Arizona, United States, 85259Keck Hospital of USC | Los Angeles California, United States, 90033LAC & USC Medical Center | Los Angeles California, United States, 90033USC / Norris Comprehensive Cancer Center | Los Angeles California, United States, 90033USC/Norris Comprehensive Cancer Center/Investigational Drug Services | Los Angeles California, United States, 90033USC/Norris Comprehensive Cancer Center | Los Angeles California, United States, 90033Keck Hospital of USC Pasadena | Pasadena California, United States, 91105Mount Sinai Comprehensive Cancer Center, Aventura | Aventura Florida, United States, 33180Mount Sinai Comprehensive Cancer Center | Miami Beach Florida, United States, 33140Mount Sinai Medical Center | Miami Beach Florida, United States, 33140BRCR Global | Plantation Florida, United States, 33322BRCR Medical Center Inc. | Plantation Florida, United States, 33322UChicago Medicine - River East | Chicago Illinois, United States, 60611University of Chicago Medical Center | Chicago Illinois, United States, 60637UChicago Medicine at Ingalls - Flossmoor | Flossmoor Illinois, United States, 60422UChicago Medicine Ingalls Memorial | Harvey Illinois, United States, 60426University of Chicago Comprehensive Cancer Center at Silver Cross Hospital | New Lenox Illinois, United States, 60451The University of Chicago Medicine Center for Advanced Care Orland Park | Orland Park Illinois, United States, 60462UChicago Medicine at Ingalls - Tinley Park | Tinley Park Illinois, United States, 60477Ochsner Clinic Foundation | New Orleans Louisiana, United States, 70121Mayo Clinic Rochester | Rochester Minnesota, United States, 55905Siteman Cancer Center - St Peters | City of Saint Peters Missouri, United States, 63376Siteman Cancer Center - West County | Creve Coeur Missouri, United States, 63141Siteman Cancer Center - North County | Florissant Missouri, United States, 63031Barnes- Jewish Hospital | St Louis Missouri, United States, 63110Washington University School of Medicine | St Louis Missouri, United States, 63110Siteman Cancer Center - South County | St Louis Missouri, United States, 63129Oncology Hematology West PC dba Nebraska Cancer Specialists | Omaha Nebraska, United States, 68114Oncology Hematology West PC dba Nebraska Cancer Specialists | Omaha Nebraska, United States, 68124Oncology Hematology West PC dba Nebraska Cancer Specialists | Omaha Nebraska, United States, 68130Oncology Hematology West PC dba Nebraska Cancer Specialists | Papillion Nebraska, United States, 68046Memorial Sloan Kettering Cancer Center - Basking Ridge | Basking Ridge New Jersey, United States, 07920Summit Medical Group | Berkeley Heights New Jersey, United States, 07922Summit Medical Group | Florham Park New Jersey, United States, 07932Memorial Sloan Kettering Cancer Center- Monmouth | Middletown New Jersey, United States, 07748Memorial Sloan Kettering Cancer Center- Bergen | Montvale New Jersey, United States, 07645Memorial Sloan Kettering Cancer Center Commack | Commack New York, United States, 11725Memorial Sloan Kettering Cancer Center - Westchester | Harrison New York, United States, 10604Memorial Sloan Kettering Cancer Center | New York New York, United States, 10022Memorial Sloan Kettering Cancer Center - Main Campus | New York New York, United States, 10065Memorial Sloan Kettering Cancer Center- Nassau | Uniondale New York, United States, 11553Cleveland Clinic Taussig Cancer Center Investigational Pharmacy | Cleveland Ohio, United States, 44195Cleveland Clinic | Cleveland Ohio, United States, 44195The Ohio State University James Cancer Hospital and Solove Research Institute | Columbus Ohio, United States, 43210Stefanie Spielman Comprehensive Breast Cancer | Columbus Ohio, United States, 43212Martha Morehouse Medical Plaza | Columbus Ohio, United States, 43221The James Outpatient Care West Campus | Columbus Ohio, United States, 43221University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer Center | Oklahoma City Oklahoma, United States, 73104Providence Cancer Institute Franz Clinic | Portland Oregon, United States, 97213Providence Portland Medical Center | Portland Oregon, United States, 97213Providence Onc and Heme Care Clinic - Westside | Portland Oregon, United States, 97225Providence St Vincent Medical Center | Portland Oregon, United States, 97225UPMC Hillman Cancer Center | Pittsburgh Pennsylvania, United States, 15232The West Clinic. PLLC. dba West Cancer Center | Germantown Tennessee, United States, 38138Henry-Joyce Cancer Center | Nashville Tennessee, United States, 37232Vanderbilt-Ingram Cancer Center | Nashville Tennessee, United States, 37232The University of Texas MD Anderson Cancer Center | Houston Texas, United States, 77030Virginia Commonwealth University | Richmond Virginia, United States, 23219Seattle Cancer Care Alliance | Seattle Washington, United States, 98109University of Washington Medical Center | Seattle Washington, United States, 98195University of Wisconsin Clinical Science Center | Madison Wisconsin, United States, 53792Centro Medico San Roque | San Miguel de Tucumán Tucumán Province, Argentina, 4000Instituto Médico Especializado Alexander Fleming | Buenos Aires , Argentina, 1426Clinica Universitaria Reina Fabiola | Córdoba , Argentina, X5004FHPHospital Privado Centro Médico de Córdoba | Córdoba , Argentina, X5016KEHChris O'Brien Lifehouse | Camperdown New South Wales, Australia, 2050Liverpool Hospital | Liverpool New South Wales, Australia, 2170GenesisCare - North Shore | St Leonards New South Wales, Australia, 2065GenesisCare North Shore | St Leonards New South Wales, Australia, 2065Royal Brisbane & Women's Hospital | Herston Queensland, Australia, 4029Princess Alexandra Hospital | Woolloongabba Queensland, Australia, 4102The Queen Elizabeth Hospital | Adelaide South Australia, Australia, 5011Monash Health | Clayton Victoria, Australia, 3168Austin Health | Heidelberg Victoria, Australia, 3084Peter MacCallum Cancer Centre | Melbourne Victoria, Australia, 3000Alfred Health | Melbourne Victoria, Australia, 3004Université Libre de Bruxelles - Hôpital Erasme | Brussels Bruxelles-capitale, Région de, Belgium, 1070Cliniques universitaires Saint-Luc | Brussels Bruxelles-capitale, Région de, Belgium, 1200Grand Hôpital de Charleroi | Charleroi Hainaut, Belgium, 6060AZ Groeninge Campus Kennedylaan | Kortrijk West-vlaanderen, Belgium, 8500ZNA Middelheim | Antwerp , Belgium, 2020UZ Leuven | Leuven , Belgium, 3000Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Liège , Belgium, 4000GZA Hospitals Campus Sint Augustinus | Wilrijk , Belgium, 2610Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA | Rio de Janeiro Rio de Janeiro, Brazil, 20230-130Hospital de Clinicas de Porto Alegre | Porto Alegre Rio Grande do Sul, Brazil, 90035-903Reichow - Centro de Ensino e Pesquisa | Blumenau Santa Catarina, Brazil, 89010-340Clínica de Neoplasias Litoral | Itajaí Santa Catarina, Brazil, 88301-220Fundação Pio XII - Hospital de Câncer de Barretos | Barretos São Paulo, Brazil, 14784400CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC | Santo André São Paulo, Brazil, 09060-650FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Onco | Santo André São Paulo, Brazil, 09060-870Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto São Paulo, Brazil, 15090000MHAT Uni Hospital OOD | Panagyurishte Pazardzhik, Bulgaria, 4500MHAT "Dr. Tota Venkova" AD | Gabrovo , Bulgaria, 5300MHAT Central Onco Hospital OOD | Plovdiv , Bulgaria, 4000Complex Oncology Center - Plovdiv EOOD | Plovdiv , Bulgaria, 4004Medical Center Nadezhda Clinical EOOD | Sofia , Bulgaria, 1303Acibadem City Clinic MHAT Tokuda | Sofia , Bulgaria, 1407University Multiprofile Hospital for Active Treatment Sofiamed | Sofia , Bulgaria, 1750Arthur J.E. Child Comprehensive Cancer Centre | Calgary Alberta, Canada, T3N 4N1Cross Cancer Institute | Edmonton Alberta, Canada, T6G 1Z2London Regional Cancer Program, London Health Sciences Centre | London Ontario, Canada, N6A 5W9Sunnybrook Health Sciences Centre | Toronto Ontario, Canada, M4N 3M5Jewish General Hospital | Montreal Quebec, Canada, H3T 1E2Cancer Hospital Chinese Academy of Medical Science | Beijing Beijing Municipality, China, 100021Beijing Cancer hospital | Beijing Beijing Municipality, China, 100142Beijing Hospital | Beijing Beijing Municipality, China, 100730Chongqing University Cancer Hospital | Chongqing Chongqing Municipality, China, 400030Fujian Medical University Union Hospital | Fuzhou Fujian, China, 350001The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou Guangdong, China, 510655Affiliated Tumor Hospital of Guangxi Medical University | Nanning Guangxi, China, 530021Affiliated Tumor Hospital of Guangxi Medical University | Nanning Guangxi, China, 530200Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan Hubei, China, 430030The Second Xiangya Hospital of Central South University | Changsha Hunan, China, 410011The Third Xiangya Hospital of Central South University | Changsha Hunan, China, 410013Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing Jiangsu, China, 210008Shengjing Hospital Of China Medical University | Shenyang Liaoning, China, 110022Shandong province cancer hospital | Jinan Shandong, China, 250117Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai Shanghai Municipality, China, 200025Shanghai General Hospital | Shanghai Shanghai Municipality, China, 200080Sichuan Province Cancer Hospital | Chengdu Sichuan, China, 610041Yunnan Cancer Hospital(The Third Affiliated Hospital of Kunming Medical University) | Kunming Yunnan, China, 650118The second Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou Zhejiang, China, 310000Peking University First Hospital | Beijing , China, 100034Fudan University Shanghai Cancer Center | Shanghai , China, 201321Tianjin Union Medical Center | Tianjin , China, 300000Fakultní nemocnice Brno Bohunice | Brno Brno-město, Czechia, 625 00Fakultni nemocnice Hradec Kralove | Hradec Králové Hradec Králové, Czechia, 500 05Fakultni Thomayerova nemocnice | Prague Praha 4, Czechia, 14059Fakultni nemocnice Olomouc | Olomouc , Czechia, 779 00Fakultni nemocnice Bulovka | Prague , Czechia, 180 81Aalborg Universitetshospital, Syd | Aalborg North Denmark, Denmark, 9000Vejle Hospital-Sygehus Lillebaelt | Vejle Region Syddanmark, Denmark, 7100Vejle Sygehus | Vejle Region Syddanmark, Denmark, 7100Rigshospitalet | Copenhagen , Denmark, 2100Herlev and Gentofte Hospital | Herlev , Denmark, 2730Odense University Hospital | Odense C , Denmark, 5000Docrates Syöpäsairaala | Helsinki Uusimaa, Finland, 00180Helsinki University Central Hospital | Helsinki , Finland, 00029Oulu University Hospital | Oulu , Finland, 90220Satakunnan Keskussairaala | Pori , Finland, 28500Tampereen yliopistollinen sairaala | Tampere , Finland, 33520Turku University Hospital | Turku , Finland, 20520Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie | Munich Bavaria, Germany, 81737Institut für Klinisch Onkologische Forschung | Frankfurt am Main Hesse, Germany, 60488Medizinische Hochschule Hannover | Hanover Lower Saxony, Germany, 30625Universitätsklinikum Leipzig | Leipzig Saxony, Germany, 04103Onkologische Schwerpunktpraxis Kurfuerstendamm | Berlin , Germany, 10707HELIOS Klinikum Berlin Buch GmbH | Berlin , Germany, 13125Radiologie Berlin | Charlottenburg , Germany, 10719Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus | Dresden , Germany, 01307Universitätsklinikum Carl Gustav Carus Dresden | Dresden , Germany, 01307Facharztzentrum Eppendorf | Hamburg , Germany, 20249ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld | Hamburg , Germany, 22045Radiologie im Israelitischen Krankenhaus | Hamburg , Germany, 22297Tata Memorial Hospital | Mumbai Maharashtra, India, 400012Deenanath Mangeshkar Hospital & Research Centre | Pune Maharashtra, India, 411 004Sahyadri Speciality Hospital | Pune Maharashtra, India, 411 004Bhakti Vedanta Hospital and Research Institute | Thane Maharashtra, India, 401107Rajiv Gandhi Cancer Institute And Research Centre | New Delhi National Capital Territory of Delhi, India, 110085R K Birla Cancer Center, SMS Hospital | Jaipur Rajasthan, India, 302004Sawai Man Singh Medical College Hospital (SMS Hospital) | Jaipur Rajasthan, India, 302004Azienda Ospedaliera Universitaria di Cagliari - Presidio Policlinico Universitario "D.Casula" | Monserrato (CA) Cagliari, Italy, 09042IRCCS Casa Sollievo della Sofferenza | San Giovanni Rotondo Foggia, Italy, 71013ASST Grande Ospedale Metropolitano Niguarda | Milan Milano, Italy, 20162Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo IRCCS | Candiolo Torino, Italy, 10060Azienda Ospedaliero Universitaria San Luigi Gonzaga | Orbassano Torino, Italy, 10043Fondazione Poliambulanza Istituto Ospedaliero | Brescia , Italy, 25124Istituto Europeo di Oncologia IRCCS | Milan , Italy, 20141Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" di Napoli | Naples , Italy, 80131IRCCS Istituto Oncologico Veneto (IOV) | Padova , Italy, 35128Azienda USL - IRCCS di Reggio Emilia - Arcispedale Santa Maria Nuova | Reggio Emilia , Italy, 42123Chiba cancer center | Chiba Chiba, Japan, 260-8717National Cancer Center Hospital East | Kashiwa Chiba, Japan, 277-8577Hokkaido University Hospital | Sapporo Hokkaido, Japan, 060-8648Kanazawa University Hospital | Kanazawa Ishikawa-ken, Japan, 920-8641St. Marianna University Hospital | Kawasaki Kanagawa, Japan, 216-8511Kanagawa cancer center | Yokohama Kanagawa, Japan, 2418515Aichi Cancer Center Hospital | Nagoya Nagoya, Aichi, Japan, 464-8681Osaka Prefectural Hospital Organization Osaka International Cancer Institute | Osaka Osaka, Japan, 5418567Kindai University Hospital | Sayama Osaka, Japan, 589-8511Osaka University Hospital | Suita Osaka, Japan, 565-0871Osaka Medical and Pharmaceutical University Hospital | Takatsuki Osaka, Japan, 569-8686Saitama Medical University International Medical Center | Hidaka Saitama, Japan, 350-1298Saitama Prefectural Cancer Center | Ina-machi Saitama, Japan, 362-0806Shizuoka Cancer Center | Nakatogari Shizuoka, Japan, 411-8777National Cancer Center Hospital | Chuo-ku Tokyo, Japan, 104-0045The Cancer Institute Hospital of JFCR | Koto-ku Tokyo, Japan, 135-8550National Hospital Organization Kyushu Cancer Center | Fukuoka , Japan, 811-1395National Hospital Organization - Osaka National Hospital - Institute For Clinical Research | Osaka , Japan, 540-0006Keio university hospital | Tokyo , Japan, 1600035Accelerium, S. de R.L. de C.V. | Monterrey Nuevo León, Mexico, 64000Centro de Investigacion Clinica de Oaxaca | Oaxaca City , Mexico, 68020Catharina Ziekenhuis | Eindhoven North Brabant, Netherlands, 5623 EJNederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) | Amsterdam North Holland, Netherlands, 1066 CXUniversitair Medisch Centrum Utrecht | Utrecht , Netherlands, 3584 CXAuckland City Hospital | Auckland , New Zealand, 1023St. Olavs hospital | Trondheim Sør-trøndelag, Norway, 7030Sørlandet Sykehus Kristiansand | Kristiansand Vest-agder, Norway, N-4615Oslo universitetssykehus, Radiumhospitalet | Oslo , Norway, 0379Oslo Universitetssykehus Ullevål | Oslo , Norway, 0450Przychodnia Lekarska KOMED | Konin Greater Poland Voivodeship, Poland, 62-500Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza | Brzozów , Poland, 36-200Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu Oddzial Onkologii | Bytom , Poland, 41-902COPERNICUS PL sp. z. o. o. Wojewodzkie Centrum Onkologii w Gdansku Ambulatoryjna | Gdansk , Poland, 80-219COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii | Gdansk , Poland, 80-219Private Medical Institution "Euromedservice" | Pushkin Sankt-Peterburg, Russia, 196603GBUZ | Chelyabinsk , Russia, 454087Kaluga Regional Clinical Oncology Center | Kaluga , Russia, 248007FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University), | Moscow , Russia, 119991BHI of Omsk Region "Clinical Oncology Dispensary" | Omsk , Russia, 644013BHI of Omsk Region "Clinical Oncology Dispensary" | Omsk , Russia, 644046LLC "Medicina Severnoy Stolitsy" | Saint Petersburg , Russia, 191025LLC "Severo-Zapadny Medical Center" | Saint Petersburg , Russia, 192007Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg | Saint Petersburg , Russia, 195271LLC "EuroCityClinic" | Saint Petersburg , Russia, 197022FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov | Saint Petersburg , Russia, 197758SHI YR Regional Clinical Oncology Hospital | Yaroslavl , Russia, 150054Narodny Onkologicky Ustav | Bratislava , Slovakia, 833 10Vychodoslovensky onkologicky ustav, a.s. | Košice , Slovakia, 04191Cancercare Rondebosch Oncology | Rondebosch CAPE TOWN, South Africa, 7700Cancercare Langenhoven Drive Oncology Centre | Port Elizabeth Eastern Cape, South Africa, 6045Wits Health Consortium (Pty) Ltd | Johannesburg , South Africa, 2193National Cancer Center | Goyang-si Gyeonggi-do, South Korea, 10408Kyungpook National University Hospital | Daegu Taegu-kwangyǒkshi, South Korea, 41404Dong-A University Hospital | Busan , South Korea, 49201Kyungpook National University Chilgok Hospital | Daegu , South Korea, 41404Gachon University Gil Medical Center | Incheon , South Korea, 21565Korea University Anam Hospital | Seoul , South Korea, 02841Seoul National University Hospital | Seoul , South Korea, 03080Severance Hospital, Yonsei University Health System | Seoul , South Korea, 03722Asan Medical Center | Seoul , South Korea, 05505Samsung Medical Center | Seoul , South Korea, 06351Complejo Hospitalario Universitario Santiago de Compostela | Santiago de Compostela A Coruña, Spain, 15706Hospital General Universitario de Elche | Elche Alicante, Spain, 03203ICO L'Hospitalet (Hospital Duran i Reynals) | L'Hospitalet de Llobregat Barcelona, Spain, 08908Hospital Universitario Vall d'Hebron | Barcelona , Spain, 08035Hospital Clinic Barcelona | Barcelona , Spain, 08036Hospital General Universitario Gregorio Marañon | Madrid , Spain, 28007Hospital Universitario Ramon Y Cajal | Madrid , Spain, 28034Hospital Universitario 12 de octubre | Madrid , Spain, 28041Hospital Universitario Virgen Del Rocio | Seville , Spain, 41013Hospital Clinico Universitario de Valencia | Valencia , Spain, 46010Hospital General Universitario de Valencia | Valencia , Spain, 46014Hospital Universitario Miguel Servet | Zaragoza , Spain, 50009Karolinska Universitetssjukhuset Solna | Solna Stockholms LÄN [se-01], Sweden, 171 64Akademiska sjukhuset | Uppsala Uppsala LÄN [se-03], Sweden, 751 85Norrlands universitetssjukhus | Umeå Västerbottens LÄN [se-24], Sweden, 90185Sahlgrenska Universitetssjukhuset | Gothenburg Västra Götalands LÄN [se14], Sweden, 413 45Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City , Taiwan, 807China Medical University Hospital | Taichung , Taiwan, 404National Cheng-Kung University Hospital | Tainan , Taiwan, 704Chi Mei Hospital, Liouying | Tainan , Taiwan, 73657National Taiwan University Hospital | Taipei , Taiwan, 100Taipei Medical University Hospital | Taipei , Taiwan, 11031Taipei Veterans General Hospital | Taipei , Taiwan, 112Chang Gung Medical Foundation-Linkou Branch | Taoyuan , Taiwan, 333Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council | Dnipro , Ukraine, 49102Ivano-Frankivsk National Medical University | Ivano-Frankivsk , Ukraine, 76018MNPE "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Regional Council" | Ivano-Frankivsk , Ukraine, 76018Communal enterprise "Kryvyi Rih Oncology Dispensary" of Dnipropetrovsk Regional Council | Kryvyi Rih , Ukraine, 50048Freeman Hospital | Newcastle upon Tyne HIGH Heaton, United Kingdom, NE7 7DNRoyal Marsden NHS Foundation Trust | Sutton Surrey, United Kingdom, SM2 5PTHeartlands Hospital | Birmingham , United Kingdom, B9 5SSHammersmith Hospital, Imperial College Healthcare NHS Trust | London , United Kingdom, W12 0HSHammersmith Hospital | London , United Kingdom, W6 8RFChurchill Hospital - Oncology | Oxford , United Kingdom, OX3 7LE
Investigators
Study Director: Pfizer CT.gov Call Center, Pfizer