NCT03575598

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Squamous Cell Carcinoma, Head And Neck
• Squamous Cell Carcinoma Mouth
• Squamous Cell Carcinoma of the Oral Cavity

Interventions

Type	Name	Description
DRUG	Sitravatinib	Sitravatinib (MGCD516) is an orally-available, potent small molecule inhibitor of a closely related spectrum of tyrosine kinases, which has shown antitumor activity in a variety of in vitro and in vivo model systems.
BIOLOGICAL	Nivolumab	Nivolumab (OPDIVO®) is a human IgG4 kappa immunoglobulin that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Timeline

• Start date: 2018-08-30
• Primary completion: 2020-02-18
• Completion: 2020-02-18
• First posted: 2018-07-02
• Last updated: 2023-07-27

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study