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NCT04675710 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer
A Phase 2 study of Thyroid Gland Anaplastic Carcinoma and Thyroid Gland Squamous Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT04675710: Active Phase 2 study of Thyroid Gland Anaplastic Carcinoma and Thyroid Gland Squamous Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT04675710 is a Phase 2 study of Thyroid Gland Anaplastic Carcinoma and Thyroid Gland Squamous Cell Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, roughly in line with the 29-participant average among 3 other Thyroid Gland Anaplastic Carcinoma trials with a reported enrollment target. The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04675710, a Phase 2 study of Thyroid Gland Anaplastic Carcinoma and Thyroid Gland Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
Overall R0/R1 resection rate will be defined by proportion of patients who undergo successful thyroidectomy with clear (R0) or microscopically positive (R1) surgical margins. We will test the hypothesis that the R0/R1 resection rate is greater than historical rate of 5%.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Quality-of-Life Assessment
- RADIATION Intensity-Modulated Radiation Therapy
- PROCEDURE Conventional Surgery
- DRUG Dabrafenib
Study Locations (6)
California
- Stanford School of Medicine - Stanford
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Ohio
- Cleveland Clinic Taussig Cancer Institute - Cleveland
Texas
- M D Anderson Cancer Center - Houston
Utah
- Huntsman Cancer Institute at the University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 2 |
What the registry record for NCT04675710 still lists
NCT04675710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, roughly in line with the 29-participant average among 3 other Thyroid Gland Anaplastic Carcinoma trials with a reported enrollment target.
The record links to 2 conditions, with Thyroid Gland Anaplastic Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04675710 lists 6 locations in 6 states (California, Michigan, Minnesota).
Frequently Asked Questions
What is clinical trial NCT04675710 about?
NCT04675710 is a clinical study titled "Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer". 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 a...
What is the current status of trial NCT04675710?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-06-24. Estimated completion is 2026-10-30.
What conditions does trial NCT04675710 study?
This clinical trial studies the following conditions: Thyroid Gland Anaplastic Carcinoma, Thyroid Gland Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04675710?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Quality-of-Life Assessment (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Conventional Surgery (PROCEDURE), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT04675710?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04675710 being conducted?
This trial has 6 study locations across California, Michigan, Minnesota, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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