Pembrolizumab in Anaplastic/Undifferentiated Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT02688608|
Recruitment Status : Completed
First Posted : February 23, 2016
Results First Posted : February 10, 2022
Last Update Posted : February 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Thyroid Cancer||Drug: Pembrolizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pembrolizumab in Metastatic or Locally Advanced Anaplastic/ Undifferentiated Thyroid Cancer|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||October 2020|
|Actual Study Completion Date :||October 2021|
200 milligrams of Pembrolizumab will be given intravenously every 3 weeks.
200 mg IV once every 3 weeks
Other Name: Keytruda-Merck
- Overall Response (OR) [ Time Frame: up to 18 months. ]
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) [ Time Frame: 2 years ]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.
- Adverse Events Associated With Pembrolizumab [ Time Frame: 2 years ]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) [ Time Frame: 2 years ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688608
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Saad Khan, MD||UT Southwestern Medical Center|