Spots Global Cancer Trial Database for A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer
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Trial Identification
Brief Title: A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer
Official Title: A Phase 1b Multicenter Pre-Surgical Study to Evaluate Immune Biomarker Modulation in Response to Motolimod (VTX-2337) in Combination With Nivolumab in Subjects With Resectable Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study ID: NCT03906526
Conditions
Study Description
Brief Summary: This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 112, Birmingham, Alabama, United States
University of Alabama at Birmingham, Birmingham, Alabama, United States
Boston University, Boston, Massachusetts, United States
Local Institution - 116, Boston, Massachusetts, United States
Local Institution - 102, Saint Louis, Missouri, United States
Washington University, Saint Louis, Missouri, United States
University of Cincinnati, Cincinnati, Ohio, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Local Institution - 101, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Local Institution - 103, Sioux Falls, South Dakota, United States
Sanford Cancer Center, Sioux Falls, South Dakota, United States
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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