Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations

Study acronym: CONCERTO
StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Study completion pushed from Aug 2026 to Oct 2026
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 2 of 4 entries
  2. Primary completion pushed from Apr 2, 2025 to Jan 2, 2026
    • Secondary endpoints: details revised at 2 of 4 entries
    v21
  3. Primary endpoint(s) modified
    • Enrollment reduced: 29 → 14 participants
    • Results first posted: Apr 24, 2026
    • Secondary endpoints revised (4)
    v20
  4. Primary completion date changed from estimate of Jan 2026 to Apr 2, 2025v19
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v18
Show 16 earlier versionsHide 16 earlier versions
  1. Primary completion date: Aug 15, 2025 to Jan 2026
    • Study completion date: Aug 15, 2026 to Aug 2026
    v17
  2. Re-verified, no change to tracked fieldsv16
  3. Eligibility criteria expanded, about 3 wordsv15
  4. Re-verified, no change to tracked fieldsv14
  5. Eligibility criteria expanded, about 7 wordsv13
  6. Study sites revised (3)v12
  7. Study sites: 2 to 3v11
  8. Study sites: 1 to 2v10
  9. Primary completion date: Aug 15, 2023 to Aug 15, 2025
    • Study completion date: Aug 15, 2025 to Aug 15, 2026
    v9
  10. Eligibility criteria expanded, about 12 wordsv8
  11. Eligibility criteria expanded, about 145 wordsv7
  12. Enrollment target: 30 to 29v6
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2021 to Jan 12, 2021
    • Site details revised
    v5
  14. Start date: Dec 15, 2020 to Jan 2021v4
  15. Start date: Oct 15, 2020 to Dec 15, 2020v3 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Secondary endpoints revised (4)
    • Study description shortened, about 14 words
    • Eligibility criteria expanded, about 1 word
  16. Start date: Aug 15, 2020 to Oct 15, 2020v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Utah
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This is an open-label, nonrandomized phase 2 trial to assess the efficacy of cobimetinib in RAS pathway activated CMML. All eligible patients will be treated daily with cobimetinib in 28-day cycles. Cobimetinib will be administered for three weeks followed by a one week break prior to the start of the following cycle. Patients will remain on study therapy until treatment discontinuation criteria is met.
Trial Details
NCT Number NCT04409639
Lead Sponsor University of Utah
Collaborators: Genentech, Inc.
Conditions
(from sponsor)		 Chronic Myelomonocytic Leukemia (CMML)
Related terms Leukemia, Myelomonocytic, Chronic
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov