Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mes… (NCT03760575) | Clinical Trial Compass
RecruitingPhase 1
Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)
United States20 participantsStarted 2023-01-10
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 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 a…
What they're measuring
1
Study related adverse events (AEs)
Timeframe: 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)