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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Celgene
- Enrollment
- 15
- Locations
- 12
- Primary Endpoint
- Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
Monotherapy Arm 2: Motolimod
Motolimod IT injection weekly
Intervention: VTX-2337 (Drug)
Combination Arm 3: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod IT injection weekly
Intervention: VTX-2337 (Drug)
Combination Arm 4: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod SC injection weekly
Intervention: VTX-2337 (Drug)
Monotherapy Arm 1: Nivolumab
Nivolumab IV every 2 weeks
Intervention: Nivolumab (Drug)
Combination Arm 3: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod IT injection weekly
Intervention: Nivolumab (Drug)
Combination Arm 4: Nivolumab and Motolimod
Nivolumab IV every 2 weeks and Motolimod SC injection weekly
Intervention: Nivolumab (Drug)
Outcomes
Primary Outcomes
Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery
Time Frame: Screening through Study Day 52
Tumor immune modulation will be evaluated by counting the number of tumor infiltration CD8+ T cells before and after treatment.
Secondary Outcomes
- Number of Patients With adverse events that lead to delay in resection(Screening through Study Day 52)
- Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod(Up to approximately 112 days)