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SBRT + Immunotherapy for Mesothelioma

Phase 1

Waitlist Available

Led By William G Breen

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has received or is planning to receive ICI for mesothelioma

Histological confirmation of pleural mesothelioma

Must not have

Nursing women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how well stereotactic body radiation therapy and immunotherapy work in treating patients with mesothelioma.

Who is the study for?

Adults with confirmed pleural mesothelioma, who can undergo stereotactic body radiation therapy (SBRT) and immunotherapy. Participants must be able to give consent, follow up at the institution, have an ECOG performance status of ≤2, not be pregnant or nursing, and agree to use effective birth control.

What is being tested?

The trial is testing how well patients with mesothelioma respond to a combination of high-precision radiation therapy called SBRT and immune-boosting treatments known as immunotherapy. The goal is to see if this combo improves tumor response while minimizing side effects.

What are the potential side effects?

Potential side effects may include damage to normal tissues near the treated area due to radiation, typical reactions from immunotherapy like flu-like symptoms, fatigue, skin reactions, potential hormonal changes from birth control methods used during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving or will receive immune therapy for mesothelioma.

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My cancer is confirmed as pleural mesothelioma.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence of acute toxicity

Incidence of late toxicity

Progression-free survival (PFS)

Other study objectives

Overall survival (OS)

Patterns of failure

Quality of life (QOL)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SBRT, immunotherapy)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

0 / 5Eligibility criteria met