Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma (NCT02959463) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma
United States24 participantsStarted 2017-05-01
Plain-language summary
This phase I trial studies the side effects and best way to give pembrolizumab after radiation therapy in treating patients with pleural malignant mesothelioma. Radiation therapy uses high energy radiation to kill tumor cells and shrink tumors. 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. Giving pembrolizumab after radiation therapy may kill more tumor cells.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have a histologic diagnosis of malignant pleural mesothelioma, with histologic diagnosis from the pleura or relevant lymph node stations, including mediastinal, hilar, or supraclavicular lymph nodes
* Be willing and able to provide written informed consent/assent for the trial
* Have measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; however, note that patients in Cohort 1 that have undergone an R0 resection will be eligible for the trial
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
* Absolute neutrophil count (ANC) \>=1,500 /mcL (within 10-15 days of treatment initiation)
* Platelets \>= 100,000 /mcL (within 10-15 days of treatment initiation)
* Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) (within 10-15 days of treatment initiation)
* Serum creatinine =\< 1.5 X upper limit of normal (ULN) or measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN (within 10-15 days of treatment initiation)
* Serum total bilirubin =\< 1.5 X ULN or direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN (within 10-15 days of treatment initiation)
* Aspartate aminotransferase (AST)…
What they're measuring
1
Safety/Toxicity
Timeframe: Baseline to 4-months after the start of radiation therapy