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PD-1 Inhibitor

Anti-PD-1 Antibody for Mesothelioma

Phase 1
Waitlist Available
Led By Hedy Kindler, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Histologically or cytologically confirmed pleural malignant mesothelioma, epithelial or biphasic subtypes
Must not have
Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids (with higher than physiologic doses) or immunosuppressive drugs). Replacement therapy (e.g.: thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after completion of treatment
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment called pembrolizumab in patients with a type of lung cancer called malignant pleural mesothelioma. All patients will have a PET/CT scan before treatment to assess their cancer and then have surgery to remove the cancer. After surgery, patients will receive standard adjuvant chemotherapy and then, if eligible, optional adjuvant treatment with pembrolizumab.

Who is the study for?
This trial is for adults with resectable malignant pleural mesothelioma who haven't had prior treatments. They must be able to provide informed consent, have measurable disease, good heart and organ function, and be physically fit enough for surgery. Women of childbearing age must use birth control and not be pregnant.
What is being tested?
The study tests pembrolizumab before surgery followed by standard chemotherapy (cisplatin and pemetrexed) after surgery. Patients may receive additional pembrolizumab for a year post-surgery if eligible.
What are the potential side effects?
Pembrolizumab can cause immune-related side effects like inflammation in various organs, skin reactions, fatigue, liver issues, lung problems (pneumonitis), hormone gland disorders, and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 is confirmed as pleural mesothelioma, either epithelial or biphasic type.
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A surgeon specializing in mesothelioma has deemed my disease can be largely removed by surgery.
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I have not received chemotherapy, targeted therapy, or immunotherapy for mesothelioma.
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I am 18 years old or older.
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I am willing to have a minor surgery to get a lung tissue sample if needed.
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My heart pumps well, with an ejection fraction over 45%.
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My lungs are strong enough for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine within the last 30 days.
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I haven't needed strong medication for an autoimmune disease in the last 2 years.
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I have not received any previous cancer treatments for mesothelioma.
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I have not taken steroids or immunosuppressants in the last 7 days.
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I have or had lung inflammation not caused by infection that needed steroids.
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I am currently being treated for an infection.
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I cannot stop my blood thinner medication for surgery.
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I have cancer that has spread to my brain or spinal cord.
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I have been diagnosed with HIV.
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I have an active tuberculosis infection.
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I have been diagnosed with interstitial lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after completion of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after completion of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gamma-Interferon Gene Expression profile (GEP) response rate defined as an increase beyond the median value of the sum of individual genes
Number of participants with adverse events related to pembrolizumab administered prior to surgery as measured by Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
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%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
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
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Pembrolizumab+Surgery+ChemotherapyExperimental Treatment2 Interventions
Neoadjuvant pembrolizumab, followed by surgery, followed by adjuvant pemetrexed and cisplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,776 Total Patients Enrolled
9 Trials studying Mesothelioma
1,241 Patients Enrolled for Mesothelioma
Hedy Kindler, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Mesothelioma
26 Patients Enrolled for Mesothelioma

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02707666 — Phase 1
Mesothelioma Research Study Groups: Pembrolizumab+Surgery+Chemotherapy
Mesothelioma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02707666 — Phase 1
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02707666 — Phase 1
~1 spots leftby Dec 2025
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