drugset / Trial / NCT04675710

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

NCT04675710

Phase 2 Active not recruiting 30 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-06-24
Primary completion
2026-10-30
Completion
2026-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabrafenib Small molecule 150 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Trametinib Small molecule 2 mg Oral