Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
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|ClinicalTrials.gov Identifier: NCT03295227|
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : November 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Stage III Thymoma AJCC v8 Stage IIIA Thymoma AJCC v8 Stage IIIB Thymoma AJCC v8 Stage IV Thymoma AJCC v8 Stage IVA Thymoma AJCC v8 Stage IVB Thymoma AJCC v8 Unresectable Thymic Carcinoma||Biological: Pembrolizumab||Phase 1|
I. To determine the safety/tolerability of pembrolizumab in unresectable patients with thymoma or thymic carcinoma who do not have pre-existing autoimmune diseases.
I. To evaluate the anti-tumor activity (response rate) of pembrolizumab in patients with unresectable thymoma or thymic carcinoma.
II. To evaluate the progression-free survival (PFS) and overall survival (OS) of pembrolizumab in patients with unresectable thymoma or thymic carcinoma.
I. We will test archival or fresh tumor tissue for PD-L1 immunohistochemistry (IHC).
II. We will perform Guardant360 blood analysis on patients with thymoma and thymic carcinoma to determine if any particular genetic mutations correlate to toxicities or clinical outcomes to pembrolizumab.
OUTLINE: This is a dose-escalation study.
Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 6 weeks for 1 year and then every 3 months for up to 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 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 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: Treatment (pembrolizumab)
Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Incidence of adverse events [ Time Frame: Up to 3 years ]Frequency tables will be used to summarize categorical variables such toxicity type and severity.
- Progression-free survival [ Time Frame: Up to 3 years ]Assessed by immune related Response Criterion (irRC) and immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST). Kaplan-Meier estimates will be constructed. Confidence intervals around the median will be calculated using the Brookmeyer-Crowley method, confidence intervals around landmark time points will use the Greenwood formula for standard errors.
- Overall survival assessed by iRECIST [ Time Frame: Up to 3 years ]Kaplan-Meier estimates will be constructed. Confidence intervals around the median will be calculated using the Brookmeyer-Crowley method, confidence intervals around landmark time points will use the Greenwood formula for standard errors.
- Overall response rate [ Time Frame: Up to 3 years ]Assessed by RECIST 1.1 and iRECIST. Response rate and its 95% confidence interval will be calculated.
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): NCT03295227
|Contact: Anne S. Tsaofirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Anne S. Tsao 713-792-6363|
|Principal Investigator: Anne S. Tsao|
|Principal Investigator:||Anne S Tsao||M.D. Anderson Cancer Center|