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Alkylating agents
Pembrolizumab + Chemotherapy for Mesothelioma
Phase 1
Recruiting
Led By Corey Langer, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
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 ECOG Performance Scale
Be 18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each subject will be assessed for os from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion)
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that combines chemotherapy with immunotherapy and surgery. The goal is to find out if it is safe and effective.
Who is the study for?
This trial is for adults with malignant pleural mesothelioma who are in good physical condition, have proper organ function, and can provide a recent tumor tissue sample. They must not have other active cancers or serious health conditions that could interfere with the study, no recent immunosuppressive treatments, and agree to use contraception.Check my eligibility
What is being tested?
The trial tests pembrolizumab (an immune therapy) combined with chemotherapy (cisplatin and pemetrexed) and image-guided surgery using Indocyanine Green (ICG). It aims to assess safety, feasibility, and initial effectiveness of this combination treatment approach.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from pembrolizumab or ICG dye used during surgery. Chemotherapy may cause nausea, fatigue, blood cell count changes increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my usual activities without help.
Select...
I am at least 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each subject will be assessed for os from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each subject will be assessed for os from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Study related adverse events (AEs)
Secondary outcome measures
Overall survival (OS)
Progression-free survival (PFS)
Side 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 with image-guided surgery and chemotherapyExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cisplatin
2013
Completed Phase 3
~1940
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,044 Total Patients Enrolled
5 Trials studying Mesothelioma
169 Patients Enrolled for Mesothelioma
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,644 Total Patients Enrolled
5 Trials studying Mesothelioma
169 Patients Enrolled for Mesothelioma
Corey Langer, MDPrincipal InvestigatorUniversity of Pennsylvania Abramson Cancer Center
5 Previous Clinical Trials
282 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with interstitial lung disease.I have had pneumonitis treated with steroids or have it now.You are allergic to ICG or pembrolizumab or any of the ingredients in these drugs.I have been diagnosed with HIV.You currently have Hepatitis B or Hepatitis C.I have an active tuberculosis infection.I agree to provide a recent biopsy sample or an archived one with approval.I can carry out all my usual activities without help.I have not taken high-dose steroids or immunosuppressants in the last week.I have another cancer besides skin or early cervical cancer that needs treatment.I have an autoimmune disease treated with medication in the last 2 years.I agree to use or continue using contraception during and up to 120 days after the study.I agree to use birth control during and up to 120 days after the study.I haven't had cancer treatment in the last 2 weeks or still have side effects, except for mild neuropathy.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.My organ functions are within normal ranges as per recent tests.I have taken a pregnancy test within the last 72 hours and it was negative.You have a disease that can be measured using certain guidelines.My cancer has spread and cannot be removed with surgery.I am currently being treated for an infection.I have not received a live vaccine in the last 30 days.I am at least 18 years old.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab with image-guided surgery and chemotherapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for people to join this experiment presently?
"Affirmative. Clinicaltrials.gov states that the trial, first posted on October 28th 2022, is actively recruiting patients. About 20 individuals are required and they must participate at one centre."
Answered by AI
To what diseases is Pembrolizumab routinely administered?
"Pembrolizumab is most frequently used to combat malignant neoplasms, and has also been successful in treating conditions such as microsatellite instability high, unresectable melanoma, and advanced non-small cell lung cancer."
Answered by AI
What prior experiments have been conducted utilizing Pembrolizumab?
"Presently, 1621 medical trials are studying the effectiveness of Pembrolizumab with 373 being in Phase 3. With many studies originating from Shanghai, there is an extensive network of 72117 clinical sites investigating this drug's efficacy."
Answered by AI
What potential risks accompany the use of Pembrolizumab?
"Based on our internal review, the safety rating of Pembrolizumab was appraised as a 1. This is owing to its Phase 1 trial designation which implies that there is limited evidence supporting both efficacy and safety."
Answered by AI
What is the total size of this clinical trial's participant pool?
"Affirmative, the clinicaltrials.gov registry shows that this medical research is currently engaging with potential participants. First posted on October 28th 2022 and most recently modified on the same day; this experiment requires 20 individuals to be recruited at a single site."
Answered by AI
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