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PD-1 Inhibitor
Pembrolizumab for Mesothelioma
Phase 2
Waitlist Available
Led By Hedy Kindler
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No more than 2 prior lines of cytotoxic therapy, which should have included pemetrexed and a platinum
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing how well pembrolizumab works in treating patients with malignant mesothelioma. Pembrolizumab is a monoclonal antibody that works by blocking PD-1, which may stimulate an immune response and kill tumor cells.
Who is the study for?
This trial is for patients with malignant mesothelioma who have seen their disease progress after treatment with pemetrexed and platinum-based chemotherapy. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and not have a history of severe autoimmune diseases or other conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing pembrolizumab, an antibody therapy targeting PD-1 proteins on immune cells to potentially enhance the body's ability to fight cancer. It includes laboratory biomarker analysis and pharmacogenomic studies to understand how genes affect a person's response to drugs.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies) and skin rash. Other possible side effects include fatigue, infusion reactions, infections due to lowered immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had 2 or fewer previous chemotherapy treatments, including pemetrexed and platinum.
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My liver function tests are within the required limits.
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My cancer is a confirmed type of mesothelioma.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer got worse after treatment with pemetrexed and platinum-based chemotherapy.
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My kidney function is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability of PD-L1 to predict response
Secondary outcome measures
Disease control rate (CR + PR + SD)
Overall survival (OS)
Progression free survival (PFS)
Other outcome measures
Analysis of T-cell receptor repertoire from TILs
CD8 TILs will be assessed by percentage of tumor showing infiltration
Composite measure of other immune escape mechanisms including MDSCs and other checkpoints
+4 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab.
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?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,298 Total Patients Enrolled
93 Trials studying Mesothelioma
8,589 Patients Enrolled for Mesothelioma
University of ChicagoLead Sponsor
1,012 Previous Clinical Trials
734,005 Total Patients Enrolled
9 Trials studying Mesothelioma
1,191 Patients Enrolled for Mesothelioma
Hedy KindlerPrincipal InvestigatorUniversity of Chicago
12 Previous Clinical Trials
1,261 Total Patients Enrolled
4 Trials studying Mesothelioma
177 Patients Enrolled for Mesothelioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood clotting time is normal or managed with medication.I have been diagnosed with HIV.My cancer is a confirmed type of mesothelioma.I have a lung condition not caused by an infection.My side effects from previous treatments are mild or back to normal.I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.You have a specific amount of disease that can be measured using specific criteria for peritoneal or pleural mesothelioma.I am fully active or restricted in physically strenuous activity but can do light work.I have mild to moderate nerve damage.You have active hepatitis B or C.My cancer got worse after treatment with pemetrexed and platinum-based chemotherapy.You have a platelet count of at least 100,000 per microliter.Your hemoglobin level is 9 grams per deciliter or higher.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I haven't had cancer treatment in the last 2 weeks or I've recovered from its side effects.I have recovered from any major surgery before starting treatment.I have another cancer, but it's either being treated, not growing, or won't affect my life expectancy.I have stable brain metastases, no new brain tumors, and haven't used steroids in the last 7 days.I don't have an active autoimmune disease needing treatment in the last 3 months, except for stable hypothyroidism or Sjogren's syndrome.I am using two birth control methods or am not having sex to join this study.I agree to use birth control during and for 4 months after the study treatment.My blood clotting time is normal or managed if I'm on blood thinners.I have been treated with specific immune system targeting drugs before.I've had 2 or fewer previous chemotherapy treatments, including pemetrexed and platinum.I have not had treatment and either refuse or can't tolerate standard chemotherapy, approved by the study lead.My liver function tests are within the required limits.My kidney function is within the required range.You have a sufficient number of a type of white blood cell called neutrophils.I have not received a live vaccine in the last 30 days.My cancer's PD-L1 status matches the criteria set in Part A of the trial.Your bilirubin levels in the blood are within a certain range.I am currently being treated for an infection.I have provided a tissue sample from my tumor for analysis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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