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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02993991
Study type Interventional
Source University Health Network, Toronto
Contact
Status Withdrawn
Phase Phase 1
Start date October 10, 2017
Completion date December 21, 2017

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02296684 - Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT03575598 - Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study Early Phase 1
Completed NCT02277197 - Ficlatuzumab and Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Phase 1
Terminated NCT00903461 - Safety and Efficacy of Radiation/Cetuximab Plus EGFR Antisense DNA for Head and Neck Squamous Cell Carcinoma Phase 1
Recruiting NCT02369458 - Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies Phase 2
Withdrawn NCT02649530 - A Phase II Trial Evaluating WNT974 in Patients With Metastatic Head and Neck Squamous Cell Carcinoma Phase 2