An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

NCT03911869

Last updated date
Study Location
Array BioPharma Investigative Site
Milano, , 20132, Italy
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Brain Metastases
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

- Histologically confirmed diagnosis of melanoma.

- Presence of B-RAF proto-oncogene, V600 mutant (BRAFV600) mutation in tumor tissue previously determined by a local assay at any time prior to Screening or by a central laboratory during Screening.

- Metastatic disease to the brain with at least 1 parenchymal brain lesion ≥ 0.5 cm and ≤ 4 cm, defined as a magnetic resonance imaging (MRI) contrast-enhancing lesion that may be accurately measured in at least 1 dimension.

- Patients may have received no more than 1 prior line of checkpoint inhibitor therapy.

- An Eastern Cooperation Oncology Group Performance Status (ECOG PS) of 0 or 1 and Karnofsky score ≥ 80

- Adequate bone marrow, organ function and laboratory parameters

Key

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


- Patients with symptomatic brain metastasis.


- Patients requiring corticosteroids for brain metastasis.


- Uveal or mucosal melanoma.


- History of or current leptomeningeal metastases.


- Prior local treatment for brain metastasis, including whole brain radiation therapy,
stereotactic radiosurgery or craniotomy.


- Either of the following:


1. Radiation therapy to non-brain visceral metastasis within 2 weeks prior to start
of study treatment;


2. Continuous or intermittent small-molecule therapeutics or investigational agents
within 5 half-lives of the agent (or within 4 weeks prior to start of study
treatment, when half-life is unknown).


- Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 12 months
prior to enrollment. Patients treated in the adjuvant setting with B-RAF
proto-oncogene, serine/threonine kinase (BRAF) or mitogen-activated protein kinase
(MEK) inhibitors ≥ 12 months prior to enrollment are eligible. Patients who received
BRAF or MEK inhibitors in the metastatic setting are excluded.


- Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before
starting study treatment.

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Brain MetastasesAn Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
NCT03911869
  1. Milano,
  2. Napoli,
  3. Los Angeles, California
  4. Orange, California
  5. San Francisco, California
  6. San Francisco, California
  7. San Marcos, California
  8. Denver, Colorado
  9. Boston, Massachusetts
  10. Ann Arbor, Michigan
  11. Grand Rapids, Michigan
  12. Rochester, Minnesota
  13. Saint Louis, Missouri
  14. Morristown, New Jersey
  15. New York, New York
  16. New York, New York
  17. Portland, Oregon
  18. Easton, Pennsylvania
  19. Pittsburgh, Pennsylvania
  20. Houston, Texas
  21. Salt Lake City, Utah
  22. Rosario, Santa Fe
  23. Buenos Aires,
  24. Caba,
  25. Coffs Harbour, New South Wales
  26. Wollstonecraft, New South Wales
  27. Melbourne, Victoria
  28. Nedlands, Western Australia
  29. Bedford Park,
  30. Melbourne,
  31. Antwerpen,
  32. Brasschaat,
  33. Kortrijk,
  34. Meldola,
  35. Milano,
  36. Padova,
  37. Torino,
  38. Newtown, Wellington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
Official Title  ICMJE A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
Brief Summary This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Metastases
Intervention  ICMJE
  • Drug: encorafenib
    taken orally
  • Drug: binimetinib
    taken orally
Study Arms  ICMJE
  • Experimental: Standard Dose Arm

    Patients in the standard-dose treatment arm will receive encorafenib and binimetinib in 28-day cycles.

    • 450 mg encorafenib orally once a day (QD)
    • 45 mg binimetinib orally twice a day (BID)
    Interventions:
    • Drug: encorafenib
    • Drug: binimetinib
  • Experimental: High Dose Arm

    Patients in the high-dose treatment arm will receive encorafenib and binimetinib in 28-day cycles.

    • 300 mg encorafenib orally twice a day (BID)
    • 45 mg binimetinib orally twice a day (BID)
    Interventions:
    • Drug: encorafenib
    • Drug: binimetinib
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: April 9, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 23, 2023
Estimated Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of melanoma.
  • Presence of B-RAF proto-oncogene, V600 mutant (BRAFV600) mutation in tumor tissue previously determined by a local assay at any time prior to Screening or by a central laboratory during Screening.
  • Metastatic disease to the brain with at least 1 parenchymal brain lesion ? 0.5 cm and ? 4 cm, defined as a magnetic resonance imaging (MRI) contrast-enhancing lesion that may be accurately measured in at least 1 dimension.
  • Patients may have received no more than 1 prior line of checkpoint inhibitor therapy.
  • An Eastern Cooperation Oncology Group Performance Status (ECOG PS) of 0 or 1 and Karnofsky score ? 80
  • Adequate bone marrow, organ function and laboratory parameters

Key Exclusion Criteria:

  • Patients with symptomatic brain metastasis.
  • Patients requiring corticosteroids for brain metastasis.
  • Uveal or mucosal melanoma.
  • History of or current leptomeningeal metastases.
  • Prior local treatment for brain metastasis, including whole brain radiation therapy, stereotactic radiosurgery or craniotomy.
  • Either of the following:

    1. Radiation therapy to non-brain visceral metastasis within 2 weeks prior to start of study treatment;
    2. Continuous or intermittent small-molecule therapeutics or investigational agents within 5 half-lives of the agent (or within 4 weeks prior to start of study treatment, when half-life is unknown).
  • Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 12 months prior to enrollment. Patients treated in the adjuvant setting with B-RAF proto-oncogene, serine/threonine kinase (BRAF) or mitogen-activated protein kinase (MEK) inhibitors ? 12 months prior to enrollment are eligible. Patients who received BRAF or MEK inhibitors in the metastatic setting are excluded.
  • Patient has not recovered to ? Grade 1 from toxic effects of prior therapy before starting study treatment.
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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Italy,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03911869
Other Study ID Numbers  ICMJE ARRAY-818-201
C4221006 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
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/d…
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020

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