A Pilot Window-Of-Opportunity Study of the Anti-PD-1 Antibody Pembrolizumab in Patients With Resectable Malignant Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT02707666|
Recruitment Status : Recruiting
First Posted : March 14, 2016
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pleural Mesothelioma||Drug: Pembrolizumab Drug: Cisplatin and Pemetrexed||Phase 1|
- To determine the rate of induction of a Gamma-Interferon Gene Expression profile (GEP) using a CLIA Nanostring nCounter based assay (performed in Merck's CLIA laboratory) in patients with malignant pleural mesothelioma treated with pembrolizumab
- To determine the safety and feasibility of neoadjuvant pembrolizumab in patients with malignant pleural mesothelioma.
- To determine 1-year progression-free survival (PFS) in patients treated with pembrolizumab via a multimodality approach (including neoadjuvant pembrolizumab, extended pleurectomy/decortication, adjuvant pemetrexed/cisplatin and if applicable adjuvant pembrolizumab).
- To determine the median overall survival (OS) for MM patients treated with pembrolizumab via a multimodality approach (including neoadjuvant pembrolizumab, extended pleurectomy/decortication, adjuvant pemetrexed/cisplatin and if applicable adjuvant pembrolizumab).
- To determine the 1-year PFS, disease free survival (DFS) and OS for PD-L1 positive or TCIP-positive MM patients treated with a multimodality approach.
- To determine safety of adjuvant pembrolizumab treatment after surgery and adjuvant chemotherapy
- To determine the objective response rate to single-agent pembrolizumab via PET/CT in previously untreated MM patients, and to correlate this response with changes in the immune microenvironment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Window-of-opportunity Study of the Anti-PD-1 Antibody Pembrolizumab in Patients With Resectable Malignant Pleural Mesothelioma|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||September 2018|
Neoadjuvant pembrolizumab, followed by surgery, followed by adjuvant pemetrexed and cisplatin
Neoadjuvant pembrolizumab every 21 days for three cycles
Drug: Cisplatin and Pemetrexed
Adjuvant chemotherapy with cisplatin and pemetrexed every 21 days for 4 cycles
- Gamma-Interferon Gene Expression profile (GEP) response rate defined as an increase beyond the median value of the sum of individual genes [ Time Frame: 12 months after completion of treatment ]Determined using a CLIA Nanostring nCounter based profiling assay
- Number of participants with adverse events as measured by CTCAEv4.0 [ Time Frame: 12 months after completion of treatment ]Adverse events will be summarized by type, grade, and relationship to the study drug.
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): NCT02707666
|Contact: Mehwish Ahmad||773 834 firstname.lastname@example.org|
|Contact: Buerkley Rose, RN||773 834 email@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Mehwish Ahmad 773-834-1472 firstname.lastname@example.org|
|Contact: Buerkley Rose, RN 773 834 4002 email@example.com|
|Principal Investigator: Hedy Kindler, M.D.|