Washington University School of Medicine
This study is a single institution non-randomized phase 2 trial looking at the effect of Pulsed Stereotactic Ablative Radiotherapy (PULSAR) followed by neoadjuvant chemotherapy dabrafenib and trametinib (DT) with or without pembrolizumab on patients with advanced anaplastic thyroid carcinoma (ATC). Pembrolizumab will be administered per standard of care (SOC) only to patients who are PDL1 positive at screening.
Inclusion Criteria: * Histologically or cytologically confirmed anaplastic thyroid cancer, AJCC 8th Edition Stage IVB-C. * Disease must be deemed unresectable, or resectable only with unacceptable functional morbidity (e.g., requiring total laryngectomy, total pharyngectomy, or extensive aerodigestive resection), as determined by multidisciplinary tumor board consensus. * BRAF-V600E positive by IHC. * Measurable disease per RECIST 1.1. * At least 18 years of age. * ECOG performance status ≤ 2 (Karnofsky ≥ 60%) * Adequate bone marrow and organ function as defined below: * Absolute neutrophi…
Dabrafenib is administered as a 150 mg pill that is taken twice daily, 12 hours a part. Dabrafenib is taken as part of a 3 week cycle.
Trametinib is administered as a 2mg pill taken once daily. Trametinib is taken as a part of a 3-week cycle.
Pembrolizumab is administered intravenously per standard of care on the Day 1 of a 3 week cycle.
PULSAR is a radiation treatment (10Gy x 1 fraction) administered up to 3 times in the neoadjuvant setting.
Ethos is a unique ring-gantry CT-guided linear accelerator notable for having a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy.
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