Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study

Official Title

Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study (SNOW)

Summary:

This is a 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 drugs, Sitravatinib and Nivolumab.

Trial Description

Primary Outcome:

• Pharmacodynamic effects with biomarker analyses
• Immune effects with biomarker analyses

Secondary Outcome:

• Toxicities as per NCI CTCAE v5.0
• Rate of completion of surgery within the initially planned window
• Rate of post-operative complications
• Rate of disease progression as per RECIST v1.1 during the pre-operative treatment period
• Pathologic treatment effect in tumour and/ or lymph nodes
• Rate of nodal extracapsular extension and positive margins
• Analysis of plasma Sitravatinib concentration before and after Nivolumab therapy

This is a single centre, 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 Sitravatinib and Nivolumab. A total of 12 patients who are evaluable for correlative studies, are planned for enrollment. This study will involve treatment with Sitravatinib and Nivolumab, 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.

View this trial on ClinicalTrials.gov