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
NCT ID: NCT03906526
Last Updated: 2023-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
15 participants
INTERVENTIONAL
2019-07-03
2022-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy Arm 1: Nivolumab
Nivolumab IV every 2 weeks
Nivolumab
IV Nivolumab
Monotherapy Arm 2: Motolimod
Motolimod IT injection weekly
VTX-2337
Motolimod
Combination Arm 3: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod IT injection weekly
VTX-2337
Motolimod
Nivolumab
IV Nivolumab
Combination Arm 4: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod SC injection weekly
VTX-2337
Motolimod
Nivolumab
IV Nivolumab
Interventions
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VTX-2337
Motolimod
Nivolumab
IV Nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
* Subject has a new clinical or pathologic diagnosis of resectable HPV+ or HPV- SCCHN of the oral cavity, pharynx, or larynx
* Macroscopic complete resection of the primary tumor must be planned and subjects should have no medical contraindication to surgery.
* Subject consents to and has tumor accessible for tumor biopsy pre-treatment.
* Subjects must have acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests.
Exclusion Criteria
* Subject has unresectable or inoperable tumors
* Subject has primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
* Subject has evidence of distant metastasis
* Subject is a pregnant or nursing female.
* Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.
* Subject has active autoimmune disease.
* Subject has clinically significant ophthalmologic disease.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
St Louis, Missouri, United States
Washington University
St 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
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1223-3488
Identifier Type: REGISTRY
Identifier Source: secondary_id
VTX-2337-HN-001
Identifier Type: -
Identifier Source: org_study_id
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