Pulsed Stereotactic Ablative Radiotherapy for Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Nikhil Rammohan, MD, PhD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for people with advanced anaplastic thyroid cancer. Participants must have tumors that can be treated with radiation and, if receiving pembrolizumab, their tumor must test positive for PDL1. Other specific health requirements may apply.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Dabrafenib
- Pembrolizumab
- Pulsed Stereotactic Ablative Radiotherapy (PULSAR)
- Trametinib
Trial Overview
The study tests a special type of targeted radiation (PULSAR) followed by chemotherapy drugs dabrafenib and trametinib. Some patients who are PDL1 positive will also get pembrolizumab. The goal is to see how well these treatments work together.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All patients will receive 2 pulses of PULSAR spaced 2 weeks apart, followed by restaging scans. Those determined to be resectable will undergo surgery followed by maintenance dabrafenib + trametinib (DT) +/- pembrolizumab (if applicable). Those who have a partial response or stable disease will then undergo a 3rd pulse of PULSAR, followed by two cycles of DT +/- pembrolizumab. Patients will again undergo restaging scans and if they are determined to be resectable, they may undergo one bridging cycle of DT +/- pembrolizumab if possible prior to surgery. After undergoing surgery, patients will undergo maintenance DT +/- pembrolizumab. If they are still unresectable, they will start on palliative DT +/- pembrolizumab. If patients experience disease progression at any of the restaging scans, patients may receive salvage DT +/- pembrolizumab on study or discontinue treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Thyroid Cancer Survivors' Association
Collaborator
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