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

Sponsor
University Health Network, Toronto
Study ID
NCT03575598
Phase
EARLY_PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sitravatinib — DRUG
    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.
  • Nivolumab — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Aug 30, 2018
Status verified
Jul 2023
Primary completion
Feb 18, 2020
Completion
Feb 18, 2020

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sitravatinib and Nivolumab
    Patients will start therapy with sitravatinib within 10 days of study enrollment. Sitravatinib will be given at 120mg once daily on a continuous basis until 48 hours before planned surgery, or for a maximum period of 28 days. Nivolumab will be given as a single infusion at a dose of 240mg, over a period of 30 minutes on Day 15 of the study.

Primary Outcome Measure

Pharmacodynamic and immune effects of pre-operative therapy with Sitravatinib and Nivolumab in patients with SCCOC [ Time Frame: 2 years ]

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