Pleural Mesothelial NeoplasmPhase 1NCT04926948
Stereotactic Body Radiation Therapy With Immunotherapy for the Treatment of Mesothelioma
A Phase 1 study testing Immunotherapy, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Pleural Mesothelial Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Mesothelial Neoplasm
- What is being tested?
- Immunotherapy, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 30 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Histological confirmation of pleural mesothelioma
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
- 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:
- Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants
Show all 14Show fewer
- Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- Intrauterine device (IUD)
- Abstinence (no sex)
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Willing to provide blood samples for correlative research purposes
- Patient has received or is planning to receive ICI for mesothelioma
- Patient is planning to receive SBRT (stereotactic body radiation therapy) for mesothelioma
Who cannot join
- Any of the following:
- Pregnant women
- Nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: SBRT With Immunotherapy for Mesothelioma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of focal stereotactic body radiation therapy (SBRT) with immune check inhibitors (ICI) for treatment of mesothelioma.
SECONDARY OBJECTIVES:
- 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:
- 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.
- 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:
- 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.
- Conditions
- Pleural Mesothelial Neoplasm
- Being tested
- Immunotherapy, Quality-of-Life Assessment, Stereotactic Body Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyOther
Also called Immunological, Immunological Therapy, Immunologically Directed Therapy
Immunotherapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SBRT, immunotherapy) | Experimental | 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. Receives: Other: Immunotherapy; Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 2 years
Secondary outcomes (3)
Progression-free survival (PFS)
Defined as the time from study entry to any progression or death.
Measured: 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.
Measured: 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.
Measured: Up to 90 days post-SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start12 Jul 2021
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Mesothelial NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William G. Breen, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926948
- Sponsor's protocol ID
- MC1924
- Other IDs
- NCI-2021-04302, MC1924, 19-012226
- Status last verified
- Jul 2026
- First submitted
- 21 May 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT With Immunotherapy for Mesothelioma
- ClinicalTrials.gov ID
- NCT04926948
- Acronym / sponsor ID
- MC1924
- Conditions
- Pleural Mesothelial Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of focal stereotactic body radiation therapy (SBRT) with immune check inhibitors (ICI) for treatment of mesothelioma.
SECONDARY OBJECTIVES:
- 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:
- 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.
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SBRT, immunotherapy) | Experimental | Other: Immunotherapy, Other: Quality-of-Life Assessment, Radiation: Stereotactic Body Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age >= 18 years
- Histological confirmation of pleural mesothelioma
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
- 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:
Key exclusion criteria (3 listed)
- Any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunotherapyAlso: Immunological, Immunological Therapy, Immunologically Directed TherapyImmunotherapy | Other | Treatment (SBRT, immunotherapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (SBRT, immunotherapy) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Treatment (SBRT, immunotherapy) |
Primary outcome
Feasibility of treating patients with stereotactic body radiation therapy (SBRT) and immune checkpoint inhibitor
Time frame: Up to 2 years
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).
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 2 years
Incidence of acute toxicity
Time frame: Up to 90 days post-SBRT
Incidence of late toxicity
Time frame: Up to 90 days post-SBRT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William G. Breen, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Immunotherapy, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Pleural Mesothelial Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of treating patients with stereotactic body radiation therapy (SBRT) and immune checkpoint inhibitor (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.