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NCT04439292 · FLOW

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Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H) · Source last updated 2026-06-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment (Dabrafenib, Trametinib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Never Start Protocol Therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Ineligible
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Still on Therapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        19
      type
      Disease Progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Patient Non Compliance
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        36
      comment
      Primary efficacy analysis set
      type
      Eligible, Treated and Mutation Status Confirmed
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For subprotocol H, patients with BRAFV600-mutated malignancies were eligible. The mutation status was determined by an NCI-MATCH approved laboratory for 20 patients in this arm. These cases had to be centrally confirmed by the MATCH assay to be usable in the primary analysis.
recruitment Details
Subprotocol H was activated on August 12, 2015, and the expansion cohort was activated on October 2, 2020. Forty-four patients were enrolled on EAY131-H between January 4, 2016, and November 22, 2022. Twenty-four patients were enrolled on the basis of the results from the NCI-MATCH assay, and 20 on the basis of the outside assay results.
Complete source fields
groups
  1. description
    Patients receive dabrafenib mesylate 150 mg PO BID and trametinib dimethyl sulfoxide 2 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment (Dabrafenib, Trametinib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Never Start Protocol Therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Ineligible
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Still on Therapy
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        19
      type
      Disease Progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Withdrawal by Subject
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Patient Non Compliance
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        36
      comment
      Primary efficacy analysis set
      type
      Eligible, Treated and Mutation Status Confirmed
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For subprotocol H, patients with BRAFV600-mutated malignancies were eligible. The mutation status was determined by an NCI-MATCH approved laboratory for 20 patients in this arm. These cases had to be centrally confirmed by the MATCH assay to be usable in the primary analysis.
recruitment Details
Subprotocol H was activated on August 12, 2015, and the expansion cohort was activated on October 2, 2020. Forty-four patients were enrolled on EAY131-H between January 4, 2016, and November 22, 2022. Twenty-four patients were enrolled on the basis of the results from the NCI-MATCH assay, and 20 on the basis of the outside assay results.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice