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Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 30, 2026 → Oct 30, 2028
See other at-risk trials from M.D. Anderson Cancer Center

Record History

  1. Notable Primary and study completion pushed from Oct 30, 2026 to Oct 30, 2028 Secondary endpoints: details revised at 3 of 8 entries · Study description revised · Eligibility criteria expanded, about 4 words Show 3 more changesShow less
    • Secondary endpoints: details revised at 3 of 8 entries
    • Study description revised
    • Eligibility criteria expanded, about 4 words
  2. Minor 4 versions Re-verified since Aug 12, 2025, no change to tracked fieldsv19-v22
  3. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 6 of 6 sitesv18 Show 1 more changeShow less
    • Site details revised at 6 of 6 sites
  4. Minor Re-verified, no change to tracked fieldsv17
  5. Notable Primary and study completion dates: Jun 30, 2024 to Oct 30, 2026v16
Show 14 earlier versionsHide 14 earlier versions
  1. Minor Secondary endpoints: details revised at 1 of 8 entries Eligibility criteria expanded, about 1 word · Study description expanded, about 2 wordsv15 Show 2 more changesShow less
    • Eligibility criteria expanded, about 1 word
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor 4 versions Re-verified since Oct 26, 2023, no change to tracked fieldsv11-v14
  3. Minor Site details revised at 1 of 6 sitesv10
  4. Minor Study sites: 3 to 6v9
  5. Minor Re-verified, no change to tracked fieldsv8
  6. Minor Study sites: 2 to 3v7
  7. Minor Re-verified, no change to tracked fieldsv6
  8. Minor Study sites: 1 to 2v5
  9. Minor Re-verified, no change to tracked fieldsv4
  10. Minor Eligibility criteria expanded, about 27 words Study description shortened, about 33 wordsv3 Show 1 more changeShow less
    • Study description shortened, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  11. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 31, 2021 to Jun 24, 2021 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jan 31, 2021 to Jun 24, 2021
    • Site details revised
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This phase II trial studies the effect of pembrolizumab, dabrafenib, and trametinib before surgery in treating patients with BRAF V600E-mutated anaplastic thyroid cancer. BRAF V600E is a specific mutation (change) in the BRAF gene, which makes a protein that is involved in sending signals in cells and in cell growth. It may increase the growth and spread of tumor cells. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab, dabrafenib, and trametinib may help to control BRAF V600E-mutated anaplastic thyroid cancer when given before surgery.
Trial Details
NCT Number NCT04675710
Lead Sponsor M.D. Anderson Cancer Center
Conditions Thyroid Gland Anaplastic Carcinoma, Thyroid Gland Squamous Cell Carcinoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov