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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
Must not have
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Select...
My liver function tests are within the required limits.
Select...
My cancer is a confirmed type of mesothelioma.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer got worse after treatment with pemetrexed and platinum-based chemotherapy.
Select...
My kidney function is within the required range.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with specific immune system targeting drugs before.
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I have been diagnosed with HIV.
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I have a lung condition not caused by an infection.
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My side effects from previous treatments are mild or back to normal.
Select...
I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.
Select...
I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
Select...
I haven't had cancer treatment in the last 2 weeks or I've recovered from its side effects.
Select...
I am currently being treated for an infection.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ability of PD-L1 to predict response
Secondary study objectives
Disease control rate (CR + PR + SD)
Overall survival (OS)
Progression free survival (PFS)
Other study objectives
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 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
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 (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 3
~2810
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,872 Total Patients Enrolled
93 Trials studying Mesothelioma
8,551 Patients Enrolled for Mesothelioma
University of ChicagoLead Sponsor
1,047 Previous Clinical Trials
758,508 Total Patients Enrolled
9 Trials studying Mesothelioma
1,183 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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