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BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04607421
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : May 6, 2021
Sponsor:
Collaborators:
Ono Pharmaceutical Co. Ltd
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Encorafenib Drug: Cetuximab Drug: Oxaliplatin Drug: Irinotecan Drug: Leucovorin Drug: 5-FU Drug: Capecitabine Drug: Bevacizumab Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 930 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : September 16, 2024
Estimated Study Completion Date : November 15, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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: 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

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
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: 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

Experimental: 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
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

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
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

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)
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




Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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 ]
  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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.

  18. 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

  19. 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.

  20. 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.

  21. 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

  22. 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

  23. 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 ]
  24. 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 ]
  25. 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 ]
  26. 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 ]
  27. 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 ]
  28. 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)

  29. 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 ]
  30. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04607421


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 60 study locations
Sponsors and Collaborators
Pfizer
Ono Pharmaceutical Co. Ltd
Merck KGaA, Darmstadt, Germany
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04607421    
Other Study ID Numbers: C4221015
2020-001288-99 ( EudraCT Number )
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Colorectal cancer
Colorectal Neoplasms
Intestinal cancer
Intestinal Neoplasms
Gastrointestinal cancer
Gastrointestinal Neoplasms
Digestive system cancer
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Bevacizumab
Cetuximab
Fluorouracil
Capecitabine
Oxaliplatin
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors