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Not yet recruiting

Study of FAK (Defactinib) and PD-1 (Pembrolizumab) Inhibition in Advanced Solid Malignancies (FAK-PD1)

By April 24, 2017No Comments

Condition

Carcinoma, Non-small-cell Lung|Mesothelioma|Pancreatic Neoplasms

Estimated Enrollment: 59

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment

Study ID Numbers: GN15ON133|2015-003928-31

Study First Received: April 20, 2016

Last Updated: June 14, 2016

Estimated Primary Completion Date: June 2018

 

Primary Outcome Measures:

Adverse events (AEs) using CTCAE v4.03 (to determine dose limiting toxicities (DLTs) and maximum tolerated dose (MTD))|Objective response rate (ORR), using best objective response by irRECIST|Duration of response (DoR)|Progression free survival (PFS) using irRECIST|Overall survival|Change in FAK Y397 phosphorylation|Change in immune cell infiltrate

Sponsors and Collaborators:

NHS Greater Glasgow and Clyde|University of Glasgow|Cancer Research UK|Merck Sharp & Dohme Corp.|Verastem, Inc.|University of Edinburgh|University of Southampton|University of Leicester|Queen’s University, Belfast

Website Link: https://ClinicalTrials.gov/show/NCT02758587

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