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PD-1 Inhibitor
Anti-PD-1 Antibody for Mesothelioma
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
A surgeon specializing in mesothelioma has deemed my disease can be largely removed by surgery.
Select...
I have not received chemotherapy, targeted therapy, or immunotherapy for mesothelioma.
Select...
I am 18 years old or older.
Select...
I am willing to have a minor surgery to get a lung tissue sample if needed.
Select...
My heart pumps well, with an ejection fraction over 45%.
Select...
My lungs are strong enough for surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Number of participants with adverse events related to pembrolizumab administered post surgery as measured by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Objective Response Rate
Overall Survival
+2 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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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: 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
1,003 Previous Clinical Trials
819,734 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to pembrolizumab or any of the ingredients in it.I have not received a live vaccine within the last 30 days.My lungs are strong enough for surgery.I haven't needed strong medication for an autoimmune disease in the last 2 years.I am fully active or restricted in physically strenuous activity but can do light work.You have a current, active infection of Hepatitis B or Hepatitis C.I have not received any previous cancer treatments for mesothelioma.I have not taken steroids or immunosuppressants in the last 7 days.I have another cancer besides skin cancer or in situ cervical cancer that needs treatment.I have or had lung inflammation not caused by infection that needed steroids.I am currently being treated for an infection.I cannot stop my blood thinner medication for surgery.My cancer is confirmed as pleural mesothelioma, either epithelial or biphasic type.A surgeon specializing in mesothelioma has deemed my disease can be largely removed by surgery.I have not received chemotherapy, targeted therapy, or immunotherapy for mesothelioma.I am 18 years old or older.I am willing to have a minor surgery to get a lung tissue sample if needed.My heart pumps well, with an ejection fraction over 45%.My organs are functioning well.I agree to use birth control during and for 4 months after the study treatment.I am using two birth control methods or am not having sex to join this study.You have a specific type of mesothelioma that can be measured or evaluated using a certain method.I have cancer that has spread to my brain or spinal cord.Your expected post-surgery carbon dioxide level in the arteries is less than 50 mmHg.I have been diagnosed with HIV.I can have a needle biopsy or provide slides/tumor block if I can't have VATS due to previous surgery or lack of space.I have an active tuberculosis infection.I have been diagnosed with interstitial lung disease.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab+Surgery+Chemotherapy
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are more participants needed in this research project?
"Affirmative. Evidence published on clinicaltrials.gov indicates that this experiment, which was originally posted in February 2016, is currently recruiting participants. Approximately 15 individuals need to be sourced from one medical facility for the trial's completion."
Answered by AI
What therapeutic purpose is Pembrolizumab regularly used for?
"Pembrolizumab is a therapeutic agent commonly used to treat malignant tumours. Additionally, it can be utilized to manage unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
What is the current capacity of this experimental research?
"Affirmative. Evidence on clinicaltrials.gov suggests that this medical study which first appeared online in February 2016 is presently accepting participants. The research initiative requires 15 patients to partake, with one site available as a point of entry."
Answered by AI
Has Pembrolizumab been granted authorization from the Food and Drug Administration?
"The safety of Pembrolizumab was rated a 1 due to limited clinical data concerning its efficacy and safety."
Answered by AI
Are there any prior studies on the efficacy of Pembrolizumab?
"As of now, 1623 clinical studies concerning pembrolizumab are active with 373 in their third phase. The majority of trials for this medication take place in Shanghai; however, there are 72163 sites worldwide conducting research on its efficacy."
Answered by AI
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