Unresectable Thymic Carcinoma Clinical Trial
Official title:
Feasibility Trial of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03694002 -
Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery
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Phase 2 |