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

Part of paid clinical trials in Stanford, California.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04675710
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Thyroid Gland Anaplastic Carcinoma
  • Thyroid Gland Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional Surgery — PROCEDURE
    Undergo surgery
  • Dabrafenib — DRUG
    Given PO
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Trametinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jun 24, 2021
Status verified
Feb 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (dabrafenib, trametinib, pembrolizumab)
    Patients receive 21-day cycles of dabrafenib 150 mg orally (PO) twice daily from Days 1-21, trametinib 2mg PO once daily from Days 1-21, and pembrolizumab 200mg intravenously (IV) on Day 1 of each cycle.

Primary Outcome Measure

Complete gross surgical resection (R0 or R1 resection) [ Time Frame: Up to 5 cycles (1 cycle = 21 days) Up to 7 cycles ]

Locations (6)

FacilityCityStateZIPSite coordinators
Stanford School of MedicineStanfordCalifornia94304-
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55901-
Cleveland Clinic Taussig Cancer InstituteClevelandOhio44195-
M D Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute at the University of UtahSalt Lake CityUtah84112-

Find similar trials in Stanford, CA

By research site
Stanford School of Medicine· Stanford, CAUniversity of Michigan Rogel Cancer Center· Ann Arbor, MIMayo Clinic· Rochester, MNCleveland Clinic Taussig Cancer Institute· Cleveland, OHM D Anderson Cancer Center· Houston, TXHuntsman Cancer Institute at the University of Utah· Salt Lake City, UT

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