Lenvatinib and Pembrolizumab for the Treatment of Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04171622|
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : July 29, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Thyroid Gland Carcinoma Poorly Differentiated Thyroid Gland Carcinoma Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8 Thyroid Gland Squamous Cell Carcinoma Unresectable Thyroid Gland Carcinoma||Drug: Lenvatinib Biological: Pembrolizumab||Phase 2|
I. Demonstrate the efficacy (overall survival [OS]) of lenvatinib plus pembrolizumab in treatment naive patients.
I. Determine the response rate and progression-free survival (PFS) in patients treated with lenvatinib plus pembrolizumab.
II. Establish safety for concurrent administration of lenvatinib plus pembrolizumab.
I. Translational endpoints: cell-free deoxyribonucleic acid (DNA) changes and immune biomarkers will be studied.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenvatinib orally (PO) daily on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lenvatinib in Combination With Pembrolizumab for Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer|
|Actual Study Start Date :||November 21, 2021|
|Estimated Primary Completion Date :||August 31, 2023|
|Estimated Study Completion Date :||August 31, 2023|
Experimental: Treatment (pembrolizumab, lenvatinib)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenvatinib PO daily on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
- Overall survival [ Time Frame: 4 years ]Kaplan-Meier method will be used to estimate the overall survival distribution. 95% confidence intervals for median and probabilities will be computed.
- Progression free survival [ Time Frame: 4 years ]
- Tumor response [ Time Frame: 4 years ]Will be assessed by Response Evaluation Criteria in Solid Tumors.
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): NCT04171622
|Contact: Maria E Cabanillasemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Maria E. Cabanillas 713-792-2841|
|Principal Investigator: Maria E. Cabanillas|
|Principal Investigator:||Maria E Cabanillas||M.D. Anderson Cancer Center|