Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03760575|
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : December 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mesotheliomas Pleural||Drug: Pembrolizumab Procedure: Indocyanine Green (ICG) Image-Guided Surgery Drug: Cisplatin Drug: Pemetrexed||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Malignant Pleural Mesothelioma (MPM)|
|Estimated Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2023|
|Experimental: Pembrolizumab with image-guided surgery and chemotherapy||
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.
Other Name: MK-3475
Procedure: Indocyanine Green (ICG) Image-Guided Surgery
Standard surgery with image guided resection.
75 mg/m2 every 3 weeks via IV infusion for 4 cycles post-surgery.
500 mg/m2 every 3 weeks via IV infusion for 4 cycles post-surgery.
- Study related adverse events (AEs) [ Time Frame: 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)
- Progression-free survival (PFS) [ Time Frame: Each subject will be assessed for PFS 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) ]Progression-free survival (PFS)
- Overall survival (OS) [ Time Frame: 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) ]Overall survival (OS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760575
|Contact: Corey Langer, MD||2156623914||Corey.Langer@uphs.upenn.edu|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Corey Langer, MD 215-622-3914 Corey.Langer@uphs.upenn.edu|
|Principal Investigator:||Corey Langer, MD||University of Pennsylvania Abramson Cancer Center|