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Trial record 1 of 1 for:    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 METAS
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BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER)

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ClinicalTrials.gov Identifier: NCT04607421
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : October 7, 2021
Sponsor:
Collaborators:
Ono Pharmaceutical Co. Ltd
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 5, 2020
First Posted Date  ICMJE October 29, 2020
Last Update Posted Date October 7, 2021
Actual Study Start Date  ICMJE December 21, 2020
Estimated Primary Completion Date September 16, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
  • Safety Lead-in Study: Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months ]
    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
  • Phase 3: Progression free survival, by blinded independent review [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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 + (Arm A) vs Control Arm (Arm C) and encorafenib and cetuximab + mFOLFOX6 or encorafenib + cetuximab + FOLFIRI (Arm B) vs the Control Arm (Arm C)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2020)
  • Safety Lead-in: Incidence of adverse events [ Time Frame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months ]
    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
  • Safety Lead-in: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms [ Time Frame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months ]
    Changes in clinical laboratory parameters, vital signs and electrocardiograms determined clinically significant at the investigator's discretion.
  • Safety Lead-in: Incidence of dose interruptions, dose modifications and discontinuations due to adverse events [ Time Frame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months ]
  • Safety Lead-in: Overall response rate by investigator [ Time Frame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months ]
    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
  • Safety Lead-in: Duration of response by Investigator [ Time Frame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months ]
    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
  • Safety Lead-in:Progression free survival by Investigator [ Time Frame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months ]
    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
  • Safety Lead-in: Time to response by Investigator [ Time Frame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months ]
    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
  • Safety Lead-in: Overall survival [ Time Frame: After 30 evaluable patients in each cohort complete 1 cycle (up to 28 days), approximately 12 months ]
    Overall survival defined as the time from the first dose to death due to any cause: encorafenib and cetuximab + mFOLFOX6 or FOLFIRI
  • Phase 3: Overall survival [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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 or encorafenib + cetuximab + FOLFIRI (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 or encorafenib + cetuximab + FOLFIRI (Arm B)
  • Phase 3: Overall response rate by blinded independent review and by Investigator [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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 or encorafenib + cetuximab + FOLFIRI (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 or encorafenib + cetuximab + FOLFIRI (Arm B)
  • Phase 3: Duration of response by blinded independent review and by Investigator [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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 or encorafenib + cetuximab + FOLFIRI (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 or encorafenib + cetuximab + FOLFIRI (Arm B)
  • Phase 3: Time to response by blinded independent review and by Investigator [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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 or encorafenib + cetuximab + FOLFIRI (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 or encorafenib + cetuximab + FOLFIRI (Arm B)
  • Phase 3: Progression free survival by Investigator [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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 or encorafenib + cetuximab + FOLFIRI (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 or encorafenib + cetuximab + FOLFIRI (Arm B)
  • Phase 3: Progression free survival 2 by Investigator [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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 or encorafenib + cetuximab + FOLFIRI (Arm B) vs Control Arm (Arm C) and encorafenib + cetuximab (Arm A) vs encorafenib + cetuximab +mFOLFOX6 or encorafenib + cetuximab + FOLFIRI (Arm B)
  • Phase 3: Incidence of adverse events [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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 or encorafenib + cetuximab + FOLFIRI (Arm B)
  • Phase 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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 or encorafenib + cetuximab + FOLFIRI (Arm B)
  • Phase 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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.
  • Phase 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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
  • Phase 3: Change from Baseline in the Patient Global Impression of Severity (PGIS) [ Time Frame: Duration of Phase 3, approximately 34 months ]
    The PGIS is a single-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time.
  • Phase 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires [ Time Frame: Duration of Phase 3, approximately 34 months ]
    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.
  • Phase 3: Confirm the MSI-status in tumor tissue [ Time Frame: Once, pre-treatment ]
    Summarize MSI-status as determined by retrospective central testing of baseline tumor tissue
  • Phase 3: Determine the correlation between cfDNA genetic alterations and clinical outcome [ Time Frame: Predose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 15 and Cycle 7 Day 1. Each cycle is 28 days for all treatments except for oxaliplatin/capecitabine treatment which is 21 days ]
    BRAF V600E variant allele fraction (VAF) and/or overall mean VAF from cfDNA analysis of plasma samples collected at baseline and on treatment
  • Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746, irinotecan and SN-38 [ Time Frame: 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 ]
  • Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38 [ Time Frame: 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. Each cycle is 28 days ]
  • Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38 [ Time Frame: 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 ]
  • Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746 and oxaliplatin [ Time Frame: 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 ]
  • Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746 and oxaliplatin [ Time Frame: 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 ]
  • Safety Lead-in: Clearance of irinotecan, SN-38 and oxaliplatin [ Time Frame: 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 ]
    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)
  • Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746 and oxaliplatin [ Time Frame: 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 ]
  • Phase 3: Trough concentrations of encorafenib and its metabolite LHY746 [ Time Frame: Predose on Cycle 1 through Cycle 6. Each cycle is 28 days ]
    Trough plasma concentrations in all patients in Arm A and Arm B
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER)
Official Title  ICMJE 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
Brief Summary 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
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: Encorafenib
    75 mg capsules
    Other Name: Braftovi, PF-07263896, LGX818, ONO-7702
  • Drug: Cetuximab
    Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial
    Other Name: Erbitux
  • Drug: Oxaliplatin
    Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial
    Other Name: Eloxatin
  • Drug: Irinotecan
    Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial
    Other Name: Campostar
  • Drug: Leucovorin
    Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial
    Other Name: Wellcovorin, Fusilev, Khapzory
  • Drug: 5-FU
    Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial
    Other Name: Fluorouracil
  • Drug: Capecitabine
    150 mg or 500 mg Tablet
    Other Name: Xeloda
  • Drug: Bevacizumab
    Optional Injection for intravenous use 100 mg/vial or 400 mg/vial
    Other Name: Zirabev
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Encorafenib
    • Drug: Cetuximab
    • Drug: Irinotecan
    • Drug: Leucovorin
    • Drug: 5-FU
  • 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
    Interventions:
    • Drug: Encorafenib
    • Drug: Cetuximab
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: 5-FU
  • Experimental: Phase 3 Arm A
    Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks
    Interventions:
    • Drug: Encorafenib
    • Drug: Cetuximab
  • Experimental: Phase 3 Arm B
    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 -OR- 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
    Interventions:
    • Drug: Encorafenib
    • Drug: Cetuximab
    • Drug: Oxaliplatin
    • Drug: Irinotecan
    • Drug: Leucovorin
    • Drug: 5-FU
  • 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- Every two weeks: Irinotecan 180 mg/m2 (90-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- 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)
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Irinotecan
    • Drug: Leucovorin
    • Drug: 5-FU
    • Drug: Capecitabine
    • Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2020)
930
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2026
Estimated Primary Completion Date September 16, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Safety Lead-In = Male/female ≥ 18 years old
  • Phase 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
  • SLI: 0-1 regimens
  • Phase 3: None
  • Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment
  • Measurable disease (Phase 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Australia,   Belgium,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04607421
Other Study ID Numbers  ICMJE C4221015
2020-001288-99 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Ono Pharmaceutical Co. Ltd
  • Merck KGaA, Darmstadt, Germany
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP