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

NCT03575598 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    collaborator INDUSTRY
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Lillian Siu, MD · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2020-02-18
Completion
2020-02-18
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03575598 on ClinicalTrials.gov