Neoplasms

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Carcinoma, Anaplastic

Carcinoma

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anaplastic Thyroid Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

200 milligrams of Pembrolizumab will be given intravenously every 3 weeks.

Saad Khan, MD

This study is being done because there are currently no approved and no commonly working targeted therapies in anaplastic thyroid cancer (ATC). This is an area of urgent need for patients, not just for approved treatments but also rationally-designed clinical trials designed specifically for ATC. Patients diagnosed with anaplastic thyroid cancer have a very high likelihood of dying because of their disease. As such there is a clear need for improving therapy for ATC.

The goal of this multi-center, open-label trial is to measure the impact of treating metastatic anaplastic thyroid cancer patients with immune checkpoint therapy. This trial will potentially lead to the development of new therapy for anaplastic thyroid cancer. The drug to be administered, pembrolizumab is FDA approved with known side effects and is active in many tumor types.

Programmed death 1 or (PD-1) PD-1/PD-L1 expression will be measured and reported for patients undergoing therapy with pembrolizumab. This will help determine if there PD-1 or PD-L1 are predictive biomarkers for anti-PD-1 therapy. It will also add to the data regarding their frequency in aggressive thyroid cancer. Where available, genomic profiling data will be analyzed to determine if there is a correlation between response and mutational status.

Pembrolizumab in Anaplastic/Undifferentiated Thyroid Cancer

Phase II Trial of Pembrolizumab in Metastatic or Locally Advanced Anaplastic/ Undifferentiated Thyroid Cancer

Overall response (OR) represents those participants that collectively achieve either complete response (CR) or partial response (PR) within 18 months, as defined below per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

* Complete Response (CR) = Disappearance of all target lesions
* Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
* Overall Response (OR) = CR + PR
* Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
* Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is reported as the cumulative number of participants receiving at least one dose of study treatment, that achieve either a CR or PR with 6 months, a number without dispersion.

Progression-free survival (PFS) means to remain alive without disease progression. Progressive disease is defined as a 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s). The outcome is reported as the number of participants who received at least one dose of study treatment and remained alive without progression at 2 years after the beginning of treatment, a number without dispersion.

Safety of the study treatment pembrolizumab is based on the number of adverse effects caused by pembrolizumab, referred to as related adverse events or toxicities. Reported adverse events (related) will be serious as defined by the Code of Federal Regulations at 21CFR§312.32, or non-serious. The outcome is reported as the number of non-serious and serious adverse events that occurred with the nominal study period (35 cycles or 2 years) that were reported as possibly, probably, or definitely related to pembrolizumab, a number without dispersion.

Overall survival (OS) means to remain alive without consideration of treatment response status.

The outcome is reported as the number of participants who received at least one dose of study treatment and were known to remain alive at 2 years after the beginning of treatment, a number without dispersion. Subjects who become lost-to-follow-up before the 2-year assessment are not included.

Merck Sharp & Dohme LLC

Saad A Khan

Assistant Professor of Medicine (Oncology)

Adverse events including grade 5 adverse events (death) are only reported for the adverse event collection period (2 years). Only adverse events and deaths occurring within 2 years are reported as adverse events.

200 milligrams of Pembrolizumab will be given intravenously every 3 weeks.

Pembrolizumab: 200 mg IV once every 3 weeks

Spots Global Cancer Trial Database for Pembrolizumab in Anaplastic/Undifferentiated Thyroid Cancer

Trial Identification

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Study Description

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