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NCT04675710

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

Active, enrolled Phase 2 Last updated 19 February 2026
What this trial tests

Phase 2 trial testing Conventional Surgery in Thyroid Gland Anaplastic Carcinoma in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
24 June 2021
Primary endpoint
30 October 2026
30 October 2026

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date24 June 2021
Primary completion30 October 2026
Estimated completion30 October 2026
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Thyroid Gland Anaplastic Carcinoma or Thyroid Gland Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting the RAS/RAF/MAPK pathway for cancer therapy: from mechanism to clinical studies.
    Bahar ME, Kim HJ, Kim DR. · · 2023 · cited 519× · PMID 38105263 · DOI 10.1038/s41392-023-01705-z
  2. Anaplastic Thyroid Carcinoma: An Update.
    Jannin A, Escande A, Al Ghuzlan A, Blanchard P, et al · · 2022 · cited 110× · PMID 35205809 · DOI 10.3390/cancers14041061
  3. Surgery After BRAF-Directed Therapy Is Associated with Improved Survival in BRAF<sup>V600E</sup> Mutant Anaplastic Thyroid Cancer: A Single-Center Retrospective Cohort Study.
    Zhao X, Wang JR, Dadu R, Busaidy NL, et al · · 2023 · cited 79× · PMID 36762947 · DOI 10.1089/thy.2022.0504
  4. Impact of Somatic Mutations on Survival Outcomes in Patients With Anaplastic Thyroid Carcinoma.
    Wang JR, Montierth M, Xu L, Goswami M, et al · · 2022 · cited 53× · PMID 35977347 · DOI 10.1200/po.21.00504
  5. Anti-Programmed Death Ligand 1 Plus Targeted Therapy in Anaplastic Thyroid Carcinoma: A Nonrandomized Clinical Trial.
    Cabanillas ME, Dadu R, Ferrarotto R, Gule-Monroe M, et al · · 2024 · cited 42× · PMID 39446377 · DOI 10.1001/jamaoncol.2024.4729
  6. Novel Inhibitor-Based Therapies for Thyroid Cancer-An Update.
    Ratajczak M, Gaweł D, Godlewska M. · · 2021 · cited 37× · PMID 34769260 · DOI 10.3390/ijms222111829
  7. Onco-immunomodulatory properties of pharmacological interference with RAS-RAF-MEK-ERK pathway hyperactivation.
    Avery TY, Köhler N, Zeiser R, Brummer T, et al · · 2022 · cited 31× · PMID 35965494 · DOI 10.3389/fonc.2022.931774
  8. What is the status of immunotherapy in thyroid neoplasms?
    Garcia-Alvarez A, Hernando J, Carmona-Alonso A, Capdevila J. · · 2022 · cited 30× · PMID 35992118 · DOI 10.3389/fendo.2022.929091

Verify or expand the search:

Other trials of Conventional Surgery

Trials testing the same drug.

Other recruiting trials for Thyroid Gland Anaplastic Carcinoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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