Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT03295227
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2017-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Feasibility Trial of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the sides effects and best dose of pembrolizumab in treating participants with thymoma or thymic cancer that cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the safety/tolerability of pembrolizumab in unresectable patients with thymoma or thymic carcinoma who do not have pre-existing autoimmune diseases.
SECONDARY OBJECTIVES:
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.
EXPLORATORY OBJECTIVES:
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.
I. To determine the safety/tolerability of pembrolizumab in unresectable patients with thymoma or thymic carcinoma who do not have pre-existing autoimmune diseases.
SECONDARY OBJECTIVES:
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.
EXPLORATORY OBJECTIVES:
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: