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Checkpoint Inhibitor

Pembrolizumab + Radiation for Mesothelioma

Phase 1
Recruiting
Led By Annemarie Shepherd, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) of IMPRINT

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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 2
~2010

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,929 Previous Clinical Trials
597,194 Total Patients Enrolled
19 Trials studying Mesothelioma
773 Patients Enrolled for Mesothelioma
Annemarie Shepherd, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
137 Total Patients Enrolled
1 Trials studying Mesothelioma
65 Patients Enrolled for Mesothelioma
Andreas Rimner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
388 Total Patients Enrolled
3 Trials studying Mesothelioma
96 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical issues does IMPRINT have the potential to ameliorate?

"IMPRINT may be utilized to manage malignant neoplasms, as well as unrelenting melanomas, microsatellite instability high diseases, and ailments that have advanced despite prior chemotherapy."

Answered by AI

On what scale is this clinical investigation being conducted?

"Affirmative. Information found on clinicaltrials.gov suggests that the trial, which was initially posted on August 10th 2021, is still searching for participants to enroll. 24 patients are needed from 7 distinct medical centres."

Answered by AI

Are there any Canadian locations currently offering this research initiative?

"The current clinical trial is taking place across 7 different sites, 4 of which are in Harrison, Rockville Centre and Basking Ridge. Participants may choose the closest location to them to lessen travel demands."

Answered by AI

Are there further investigations being conducted with IMPRINT?

"IMPRINT's initial research began in 2010 at City of Hope. To this day, there are 251 concluded studies and 961 ongoing trials, the majority being held in Harrison, New york."

Answered by AI

Is enrollment still open for participation in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical study – which was first published on August 10th 2021– is still recruiting patients. 24 individuals are required across 7 different trial sites."

Answered by AI

Has the IMPRINT treatment been cleared for public use by federal regulators?

"In the estimation of our team at Power, IMPRINT has been judged to possess a level 1 safety rating; due to it being in Phase 1 trials and having limited supporting evidence as regards efficacy."

Answered by AI
~11 spots leftby Aug 2026