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Checkpoint Inhibitor

Pembrolizumab + Radiation for Mesothelioma

Phase 1
Recruiting
Led By Charles Simone, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable per thoracic surgeon assessment
Have a ECOG performance status of 0 to 1
Must not have
Serious infection, concurrent active malignancies, or other serious medical illness
Known history of HIV, Hepatitis B, active Hepatitis C virus infection, active TB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety of combining two drugs to treat mesothelioma. The goal is to find the highest dose of one drug that causes few side effects when combined with the other drug. If the combination is effective, it will be tested on more people in the future.

Who is the study for?
This trial is for adults with malignant pleural mesothelioma who've had at least one prior systemic therapy. They must not be pregnant, agree to use contraception, and have certain lung function levels (DLCO >40%, FEV1 >50%). Exclusions include recent participation in other trials, specific treatments or vaccines within the last month, certain medical conditions including active infections or pneumonitis, and known hypersensitivity to pembrolizumab.
What is being tested?
The study tests IMPRINT combined with pembrolizumab to determine a safe dosage and its effectiveness against mesothelioma. Participants will first help find the highest dose of IMPRINT that's tolerable when used with pembrolizumab before it's tested as a potential treatment option.
What are the potential side effects?
Possible side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drug administration process, fatigue, digestive issues like nausea or diarrhea, blood disorders such as anemia or clotting problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My doctor says my lung condition can't be treated with surgery.
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I can carry out all my usual activities without help.
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I am fully active or can carry out light work.
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I am 18 years or older and have given my consent.
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I have been diagnosed with cancer of the lung lining.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious infections, other cancers, or major illnesses.
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I have a history of HIV, Hepatitis B, active Hepatitis C, or active TB.
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My cancer has spread to my brain or its coverings.
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I have been recently diagnosed with mesothelioma.
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I haven't taken certain medications in the last 4 weeks or still have side effects.
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I have an immune system disorder or have been taking more than 10 mg of steroids daily.
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I have had pneumonitis treated with steroids or have it now.
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I have not needed treatment for an autoimmune disease in the last 2 years.
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I have had radiation therapy or treatment inside my chest area before.
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I had major surgery less than 4 weeks before starting pembrolizumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD) of IMPRINT

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: Participants with malignant pleural mesothelioma (MPM)Experimental Treatment2 Interventions
Participants will be diagnosed with malignant pleural mesothelioma and be deemed unresectable per thoracic surgeon assessment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,335 Total Patients Enrolled
20 Trials studying Mesothelioma
790 Patients Enrolled for Mesothelioma
Charles Simone, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
241 Total Patients Enrolled
1 Trials studying Mesothelioma
65 Patients Enrolled for Mesothelioma
Annemarie Shepherd, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
142 Total Patients Enrolled
1 Trials studying Mesothelioma
65 Patients Enrolled for Mesothelioma

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04897022 — Phase 1
Mesothelioma Research Study Groups: Participants with malignant pleural mesothelioma (MPM)
Mesothelioma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04897022 — Phase 1
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04897022 — Phase 1
~8 spots leftby Aug 2026
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