Trials / Completed
CompletedNCT02688608
Pembrolizumab in Anaplastic/Undifferentiated Thyroid Cancer
Phase II Trial of Pembrolizumab in Metastatic or Locally Advanced Anaplastic/ Undifferentiated Thyroid Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Saad A Khan · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | 200 mg IV once every 3 weeks |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2020-10-01
- Completion
- 2021-10-01
- First posted
- 2016-02-23
- Last updated
- 2022-02-10
- Results posted
- 2022-02-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02688608. Inclusion in this directory is not an endorsement.