Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

NCT03693170

Last updated date
Study Location
Beatson West of Scotland Cancer Centre
Glasgow, , G12 0YN, United Kingdom
Contact
1-800-718-1021

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By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
BRAF V600E-mutant Metastatic Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female ≥ 18 years of age

- Histologically or cytologically confirmed CRC that is metastatic

- Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening and confirmed by central laboratory

- Evidence of measurable disease as per RECIST, v1.1

- Subject able to receive cetuximab as per approved label with regards to RAS status

- ECOG Status 0 or 1

- Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol

- Subject able to take oral medications

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior systemic therapy for metastatic disease


- Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR
inhibitors


- Symptomatic brain metastasis or Leptomeningeal disease


- History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors
for RVO


- History of chronic inflammatory bowel disease or Crohn's disease requiring medical
intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12
months prior to first dose.


- Impaired cardiovascular function or clinically significant cardiovascular diseases:
history of myocardial infarction or coronary disorders within 6 months prior to start
of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or
current clinically significant arrhythmia and/or conduction disorder within 6 months
prior to study treatment start


- History of thromboembolic or cerebrovascular events within 6 months prior to start of
study treatment


- Concurrent neuromuscular disorder that is associated with potential elevation of
Creatine Kinase


- Known contraindication to cetuximab administration as per SPC/approved label

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Pfizer Clinical Trials Contact Center

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BRAF V600E-mutant Metastatic Colorectal CancerEncorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
NCT03693170
  1. Glasgow,
  2. Duarte, California
  3. Los Angeles, California
  4. Aurora, Colorado
  5. New Haven, Connecticut
  6. Westwood, Kansas
  7. Saint Louis, Missouri
  8. New York, New York
  9. Germantown, Tennessee
  10. Temple, Texas
  11. Fairfax, Virginia
  12. Wiener Neustadt, Lower Austria
  13. Salzburg,
  14. Wien,
  15. Gent, East Flanders
  16. Gent, East Flanders
  17. Leuven, Flemish Brabant
  18. Antwerp,
  19. Brussels,
  20. Le Mans,
  21. Marseille,
  22. Paris,
  23. Paris,
  24. Paris,
  25. Pessac,
  26. Saint-Herblain,
  27. Toulouse,
  28. San Giovanni Rotondo, Foggia
  29. Meldola, Forlì-Cesena
  30. Candiolo,
  31. Perugia,
  32. Nagoya, Aichi
  33. Kashiwa, Chiba
  34. Fukuoka-shi, Fukuoka
  35. Osaka-shi, Osaka
  36. Nagaizumi-cho, Shizuoka
  37. Koto-ku,, Tokyo
  38. Amsterdam,
  39. Tilburg,
  40. Utrecht,
  41. Utrecht,
  42. Madrid, Community Of Madrid
  43. Pamplona, Navarre
  44. Barcelona,
  45. Barcelona,
  46. Barcelona,
  47. Barcelona,
  48. Madrid,
  49. Madrid,
  50. Madrid,
  51. Toledo,
  52. Valencia,
  53. Valencia,
  54. Vigo,
  55. Torquay, Devon
  56. Romford, Essex
  57. Sutton, Surrey
  58. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
BRAF V600E-mutant Metastatic Colorectal CancerStudy of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
NCT02928224
  1. Phoenix, Arizona
  2. Corona, California
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  4. Fountain Valley, California
  5. Fullerton, California
  6. Los Angeles, California
  7. Riverside, California
  8. Aurora, Colorado
  9. New Haven, Connecticut
  10. Washington, District of Columbia
  11. Fort Lauderdale, Florida
  12. Jacksonville, Florida
  13. Miami, Florida
  14. Atlanta, Georgia
  15. Chicago, Illinois
  16. Peoria, Illinois
  17. Urbana, Illinois
  18. Indianapolis, Indiana
  19. New Albany, Indiana
  20. Iowa City, Iowa
  21. Westwood, Kansas
  22. New Orleans, Louisiana
  23. Baltimore, Maryland
  24. Boston, Massachusetts
  25. Boston, Massachusetts
  26. Ypsilanti, Michigan
  27. Rochester, Minnesota
  28. Saint Louis, Missouri
  29. Saint Louis, Missouri
  30. Lebanon, New Hampshire
  31. Albuquerque, New Mexico
  32. New York, New York
  33. Canton, Ohio
  34. Cleveland, Ohio
  35. Toledo, Ohio
  36. Portland, Oregon
  37. Danville, Pennsylvania
  38. Pittsburgh, Pennsylvania
  39. Nashville, Tennessee
  40. Houston, Texas
  41. Temple, Texas
  42. Seattle, Washington
  43. Spokane, Washington
  44. Madison, Wisconsin
  45. Darlinghurst, New South Wales
  46. Heidelberg, Victoria
  47. Parkville, Victoria
  48. Reims, Cedex
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  57. Paris,
  58. Périgueux,
  59. Toulouse,
  60. Ulm, Baden-Württemberg
  61. München, Bayern
  62. Schweinfurt, Bayern
  63. Hannöver, Niedersachsen
  64. Oldenburg, Niedersachsen
  65. Essen, Nordrhein-Westfalen
  66. Essen, Nordrhein-Westfalen
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  71. Berlin,
  72. Hamburg,
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  76. Monza, Milano
  77. Milano, MI
  78. Aviano, Pordenone
  79. Ancona,
  80. Bergamo,
  81. Bologna,
  82. Cremona,
  83. Firenze,
  84. Milano,
  85. Milano,
  86. Milano,
  87. Napoli,
  88. Padova,
  89. Pisa,
  90. Roma,
  91. Roma,
  92. Roma,
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  95. Hammersmith, London
  96. Glasgow, Scotland
  97. Guildford, Surrey
  98. London,
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  100. Manchester,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
Official Title  ICMJE Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer
Brief Summary The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.
Detailed Description The presence of a BRAFV600E mutation is considered a marker of poor prognosis in subjects with mCRC. The preclinical results and preliminary clinical data together justify the evaluation of this triple combination in the first-line setting of this population. The primary objective of the study is to evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the overall response rate in adult subjects with previously untreated BRAFV600E-mutant metastatic colorectal cancer. It will also assess the effect of the triple combination on the duration of response, time to response, progression-free survival and overall survival and assess the effect on quality of life. It will also characterize the safety and tolerability of the triple combination as well as describe the pharmacokinetics (PK) of encorafenib, binimetinib, and cetuximab.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
All involved know the identity of the intervention assignment.
Primary Purpose: Treatment
Condition  ICMJE BRAF V600E-mutant Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: encorafenib
    Once daily, orally
  • Drug: Binimetinib
    Twice daily, orally
  • Drug: Cetuximab
    Standard of care for the 28 first weeks and then every 2 weeks
Study Arms  ICMJE Experimental: 1 Arm
encorafenib plus binimetinib plus cetuximab
Interventions:
  • Drug: encorafenib
  • Drug: Binimetinib
  • Drug: Cetuximab
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2020)
95
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
90
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female ? 18 years of age
  • Histologically or cytologically confirmed CRC that is metastatic
  • Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening and confirmed by central laboratory
  • Evidence of measurable disease as per RECIST, v1.1
  • Subject able to receive cetuximab as per approved label with regards to RAS status
  • ECOG Status 0 or 1
  • Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol
  • Subject able to take oral medications

Exclusion Criteria:

  • Prior systemic therapy for metastatic disease
  • Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors
  • Symptomatic brain metastasis or Leptomeningeal disease
  • History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO
  • History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ? 12 months prior to first dose.
  • Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start
  • History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment
  • Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase
  • Known contraindication to cetuximab administration as per SPC/approved label
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Italy,   Japan,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03693170
Other Study ID Numbers  ICMJE W00090 GE 2 01
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 Not Provided
Responsible Party Pierre Fabre Medicament
Study Sponsor  ICMJE Pierre Fabre Medicament
Collaborators  ICMJE
  • Pfizer
  • Merck KGaA, Darmstadt, Germany
  • Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director:Karim Keddad, MDPierre Fabre Medicament
PRS Account Pierre Fabre Medicament
Verification Date September 2020

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