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.
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.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Has a known history of active TB (Bacillus tuberculosis).
Hypersensitivity to pembrolizumab or any of its excipients.
Single group
Pembrolizumab
Biological/VaccineGiven IV
Incidence of adverse events
Frequency tables will be used to summarize categorical variables such toxicity type and severity.
Progression-free survival
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
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
Assessed by RECIST 1.1 and iRECIST. Response rate and its 95% confidence interval will be calculated.
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
