Feasibility Trial of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma
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|ClinicalTrials.gov Identifier: NCT03295227|
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : December 24, 2018
There are 2 parts in this study.
The goal of Part 1 of this clinical research study is to confirm the highest tolerable dose of pembrolizumab that can be given to patients with unresectable thymoma or thymic cancer.
The goal of Part 2 of this clinical research study is to learn if pembrolizumab given at the dose that was found in Part 1 of the study can help to control thymoma or thymic cancer.
The safety of the study drug will be studied in both parts.
This is an investigational study. Pembrolizumab is FDA approved and commercially available for treatment of many types of cancers. It is considered investigational to use pembrolizumab to treat thymoma or thymic cancer.
The study doctor can describe how pembrolizumab is designed to work.
Up to 30 participants will be enrolled in this study. All will take part in MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Thymoma Thymic Cancer||Drug: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Trial of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma|
|Actual Study Start Date :||December 6, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Part 1: Participants receive Pembrolizumab by vein over about 30 minutes on Day 1 of every 21 day Cycle.
Part 2: Participants received Pembrolizumab at the maximum tolerated dose from Part 1.
Part 1: 200 mg by vein on Day 1 of every 21 day cycle.
Part 2: Maximum tolerated dose from Part 1.
- Dose Limiting Toxicity (DLT) of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma [ Time Frame: 21 days ]DLT defined as having the development of grade 5 non-hematologic toxicity or grade 4-5 autoimmune diseases that are possibly, probably or definitely related to protocol treatment.
- Response Rate of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma [ Time Frame: Every 6 weeks up to 2 years ]Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295227
|Contact: Anne S. Tsao, MDemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations firstname.lastname@example.org|
|Principal Investigator:||Anne S. Tsao, MD||M.D. Anderson Cancer Center|