Feasibility Trial of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma
M.D. Anderson Cancer Center
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.
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 (…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Unresectable thymoma or thymic carcinoma. * Any line of prior therapy allowed. * Be willing and able to provide written informed consent/assent for the trial. * Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may…
Interventions
- BiologicalPembrolizumab
Given IV
Location
- M D Anderson Cancer CenterHouston, Texas