Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02993991

Pre-operative Mocetinostat (MGCD0103) and Durvalumab (MEDI4736) (PRIMED) for Squamous Cell Carcinoma of the Oral Cavity

Status
Withdrawn
Phase
Phase 1
Study type
Interventional
Enrollment
0 (actual)
Sponsor
University Health Network, Toronto · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a Phase 1 Window of Opportunity study to evaluate the pharmacodynamic and immune effects of pre-operative therapy with Mocetinostat and Durvalumab on patients with squamous cell carcinoma of the oral cavity.

Detailed description

This is a single center, open-label, non-randomized, pre-operative window of opportunity study for patients with resectable squamous cell carcinoma of the oral cavity who are considered suitable for curative-intent surgical resection, with pre-operative Mocetinostat and Durvalumab. This study will involve treatment with Mocetinostat and Durvalumab, tests and procedures done for safety and the collection of blood samples for biomarker research. Tissue samples (fresh biopsy or archival tissue) will also be collected for biomarker research and evaluation.

Conditions

Interventions

TypeNameDescription
DRUGMocetinostatMocetinostat (MGCD0103) is a potent small molecule HDAC inhibitor that targets human HDAC isoforms. It is an orally bioavailable, second generation benzamide inhibitor of HDAC 1, 2, 3 and 11 with broad spectrum antitumor activity in vitro and in vivo.
BIOLOGICALDurvalumabDurvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody directed against human PD-L1. It is selective for recombinant PD-L1 and blocks the binding of recombinant PD-L1 to the PD-1 and CD80 receptors.

Timeline

Start date
2017-10-10
Primary completion
2017-12-21
Completion
2017-12-21
First posted
2016-12-15
Last updated
2017-12-29

Locations

1 site across 1 country: Canada

Regulatory

Source: ClinicalTrials.gov record NCT02993991. Inclusion in this directory is not an endorsement.