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Recruiting

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 - VTX-2337-HN-001

Updated: 29 January, 2021   |   ClinicalTrials.gov

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Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 10

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Combination Arm 3: Nivolumab and Motolimod
Drug: VTX-2337 Drug: Nivolumab
Experimental: Combination Arm 4: Nivolumab and Motolimod
Drug: VTX-2337 Drug: Nivolumab
Experimental: Monotherapy Arm 1: Nivolumab
Drug: Nivolumab
Experimental: Monotherapy Arm 2: Motolimod
Drug: VTX-2337

Key Eligibility Criteria

Inclusion Criteria: - Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). - 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 any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study - 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.

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com