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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Monotherapy Arm 1: Nivolumab 		Nivolumab IV every 2 weeks
  • Drug: Nivolumab
    IV Nivolumab
    Other names:
    • Opdivo
Experimental
Monotherapy Arm 2: Motolimod 		Motolimod IT injection weekly
  • Drug: VTX-2337
    Motolimod
    Other names:
    • VTX-378
Experimental
Combination Arm 3: Nivolumab and Motolimod 		Nivolumab IV every 2 weeks and Motolimod IT injection weekly
  • Drug: VTX-2337
    Motolimod
    Other names:
    • VTX-378
  • Drug: Nivolumab
    IV Nivolumab
    Other names:
    • Opdivo
Experimental
Combination Arm 4: Nivolumab and Motolimod 		Nivolumab IV every 2 weeks and Motolimod SC injection weekly
  • Drug: VTX-2337
    Motolimod
    Other names:
    • VTX-378
  • Drug: Nivolumab
    IV Nivolumab
    Other names:
    • Opdivo

More Details

Status
Terminated
Sponsor
Celgene

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.