Neoplasms

All Conditions

Blood and Lymph Conditions

Carcinoma

Thymoma

Thymus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

Anne S. Tsao

Anne S Tsao

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.

Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer

Feasibility Trial of Pembrolizumab in Unresectable Thymoma and Thymic Carcinoma

Frequency tables will be used to summarize categorical variables such toxicity type and severity.

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.

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.

Assessed by RECIST 1.1 and iRECIST. Response rate and its 95% confidence interval will be calculated.

Spots Global Cancer Trial Database for stage iii thymoma ajcc v8