Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)
Abramson Cancer Center at Penn Medicine
Summary
The study is a single-arm phase I trial to evaluate the safety, feasibility, and preliminary efficacy of the addition of pembrolizumab and image-guided resection to surgical therapy and chemotherapy for malignant pleural mesothelioma (MPM).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 per…
Interventions
- DrugPembrolizumab
Pembrolizumab 200mg via IV infusion every 3 weeks for 2 cycles 3 pre-surgery, for 4 cycles post-surgery and then every 3 weeks during maintenance.
- ProcedureIndocyanine Green (ICG) Image-Guided Surgery
Standard surgery with image guided resection.
- DrugCisplatin
75 mg/m2 every 3 weeks via IV infusion for 4 cycles post-surgery.
- DrugPemetrexed
500 mg/m2 every 3 weeks via IV infusion for 4 cycles post-surgery.
Location
- Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania