A Phase 1 interventional study of Immunotherapy and Quality-of-Life Assessment in Pleural Mesothelial Neoplasm, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
This phase I trial studies the effect of stereotactic body radiation therapy and immunotherapy in treating patients with mesothelioma. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving stereotactic body radiation therapy and immunotherapy may improve the tumors response to the treatment and decrease side-effects.
PRIMARY OBJECTIVE:
I. To determine the feasibility of focal stereotactic body radiation therapy (SBRT) with immune check inhibitors (ICI) for treatment of mesothelioma.
SECONDARY OBJECTIVES:
I. To determine progression free survival in patients treated with SBRT and ICI.
II. To assess acute and late toxicities overall in patients treated with SBRT and ICI.
TERTIARY OBJECTIVES:
I. To demonstrate that pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) levels correlate with tumor burden in patients with solid tumors.
II. To investigate if ctDNA can robustly identify molecular residual disease (MRD) before clinical, radiographic or pathologic progression in patients with solid tumors treated with definitive-intent surgery +/- radiotherapy +/- chemotherapy.
III. To determine whether post-resection ctDNA levels can be used to predict the risk of tumor recurrence and response to adjuvant radiation or adjuvant chemoradiation in patients with solid tumors.
IV. To determine if ctDNA levels can predict disease response and/or disease recurrence before clinical, pathologic or radiographic response/progression is confirmed in patients with solid tumors.
V. To perform methylation sequencing of cell-free DNA to noninvasively determine ctDNA cell- of-origin.
VI. To perform cell-free ribonucleic acid (RNA) analysis to monitor gene expression changes and identify genomic rearrangements.
VII. To perform epigenetic and genetic analyses including methylation sequencing and single cell RNA sequencing on associated tumor and peripheral blood cell samples.
EXPLORATORY OBJECTIVES:
I. To determine overall survival in these patients. II. To estimate the objective response rate (ORR) using immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1 criteria.
III. To describe patterns of failure. IV. To estimate the quality of life (QOL) in these patients. V. Determine whether T-cell receptor expression changes during and after immunotherapy and SBRT, and whether these changes correlate with outcomes.
VI To evaluate potential predictive and prognostic biomarkers using various assays including flow cytometry assays, qualitative and quantitative analyses of patients' blood to explore associations with all primary and secondary endpoints.
OUTLINE:
Patients undergo 3-5 daily fractions of SBRT in the absence of disease progression or unacceptable toxicity. Patients also receive immunotherapy at the discretion of the treating medical oncologist.
After completion of study treatment, patients are followed up every 6 weeks for 36 weeks or per clinician discretion, then every 3 months for 2 years or until disease progression or study exit, then yearly for up to 10 years.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Negative pregnancy test done =\< 14 days prior to registration, for women of childbearing potential only. NOTE: male/female: Must be willing to use birth control for the entire study and must agree to use one of the following birth control methods listed:
Exclusion Criteria:
Any of the following:
Patients undergo 3-5 daily fractions of SBRT in the absence of disease progression or unacceptable toxicity. Patients also receive immunotherapy at the discretion of the treating medical oncologist.
Other: Immunotherapy · Other: Quality-of-Life Assessment · Radiation: Stereotactic Body Radiation Therapy
Immunotherapy
Also known as: Immunological, Immunological Therapy, Immunologically Directed Therapy
Ancillary studies
Also known as: Quality of Life Assessment
Undergo SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Feasibility of treating patients with stereotactic body radiation therapy (SBRT) and immune checkpoint inhibitor
Feasibility of treating patients with SBRT and ICI will be determined by ability to treat all enrolled patients without meeting stopping rules (maintaining \<30%toxicity).
Time frame: Up to 2 years
Progression-free survival (PFS)
Defined as the time from study entry to any progression or death.
Time frame: Up to 2 years
Incidence of acute toxicity
The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will assess and summarize all acute and late AE's, regardless of attribution.
Time frame: Up to 90 days post-SBRT
Incidence of late toxicity
The maximum grade for each type of adverse event will be summarized using CTCAE version 5.0. Will assess and summarize all acute and late AE's, regardless of attribution.
Time frame: Up to 90 days post-SBRT
Response rate
Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST). The frequency and percentage of responses will be calculated.
Time frame: Up to 2 years
Patterns of failure
Will be described descriptively as well using standard summary statistics (frequencies, percentages, etc.).
Time frame: Up to 2 years
Quality of life (QOL)
Will be assessed using the Lung Cancer Symptom Scale (LCSS), which consists of nine questions assessing QOL in the past day. Questions are answered on a 10-point scale where 0=as good as it can be and 9=as bad as it can be. Lower score correspond to better QOL.
Time frame: Baseline up to 2 years
T-cell receptor expression changes
Will correlate changes with outcomes (PFS, OS, response, etc.). Potential predictive and prognostic biomarkers using various assays including flow cytometry assays, quality and quantitative analysis of patients' blood to explore associations with all primary and secondary endpoints will also be evaluated. Due to the limited sample size, these analyses will be hypothesis generating and descriptive in nature. Descriptive statistics will be summarized and the blood and tissue marker data will be correlated with clinical endpoints (PFS, OS, response, etc.). For time-to-event data, the Kaplan-Meier method will be used. For categorical data, will use the Fisher's exact test. For biomarker data used to predict binary outcomes (i.e. response versus no response), will use logistic regression models.
Time frame: Baseline up to 2 years
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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