Pembrolizumab and Image-Guided Surgery for Malignant Pleural Mesothelioma
This study is looking at a new way to treat malignant pleural mesothelioma (a type of cancer affecting the lining of the lungs). It combines standard surgery with image-guided resection (a technique using imaging to help surgeons remove tumors more precisely), chemotherapy (Cisplatin and Pemetrexed), and a drug called Pembrolizumab. Researchers want to see if this combination treatment is safe, practical, and if it shows early signs of working. You might be able to join if you are 18 or older, have measurable disease, and are willing to provide a tissue sample from your tumor. The main goal is to track any side effects you might experience during and after treatment.
- Study design
- This is a single-arm Phase 1 study, meaning all 20 participants will receive the same treatment. It aims to evaluate the safety and early effectiveness of the combined therapy.
- What's involved
- You would receive Pembrolizumab infusions before and after surgery, and chemotherapy infusions after surgery. You will be assessed for side effects for up to 90 days after your last treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for side effects for up to 30 days after your last treatment, and for serious side effects for up to 90 days after your last treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03760575
Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)
Recruiting
PHASE1Ages 18+InterventionalTreatmentAbramson Cancer Center at Penn MedicineInvestigator-initiated
~20 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:PembrolizumabIndocyanine Green (ICG) Image-Guided SurgeryCisplatinPemetrexed
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Study related adverse events (AEs)
Measured over Each subjects will be assessed for AEs from the time of their first study treatment until 30 days after the end of their treatment for AEs and until 90 days after their last treatment for serious AEs (study treatment may last for up to 1 year)
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Corey Langer, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania Abramson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Be willing and able to provide written informed consent for the trial.
Be 18 years of age on day of signing informed consent.
Have measurable disease based on RECIST 1.1.
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
Have a performance status of 0 or 1 on the ECOG Performance Scale.
Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation.
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Exclusion
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment OR Is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of trial treatment. (Note: Subjects with asthma or chronic obstructive pulmonary disease that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.)
Has a known history of active TB (Bacillus Tuberculosis)
Hypersensitivity to ICG or pembrolizumab or any of their excipients.
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Has known metastatic disease and/or disease that is otherwise determined to be unresectable.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Evidence of interstitial lung disease.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
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
What this trial measures
- Study related adverse events (AEs)Each subjects will be assessed for AEs from the time of their first study treatment until 30 days after the end of their treatment for AEs and until 90 days after their last treatment for serious AEs (study treatment may last for up to 1 year)
Study related adverse events (AEs)