Carcinoma, Squamous Cell
Conditions
Keywords
Motolimod, Nivolumab, Head and Neck Cancer, Squamous Cell Carcinoma, Checkpoint inhibitor, anti-PD1 inhibitor, TLR 8 agonist
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.
Interventions
DRUGVTX-2337
Motolimod
DRUGNivolumab
IV Nivolumab
Sponsors
Celgene
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With adverse events that lead to delay in resection | Screening through Study Day 52 | Study will evaluate the number of patients who experience adverse events that lead to a significant delay in surgical resection. |
| Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod | Up to approximately 112 days | Subject will be monitored for AEs both during treatment and for a specified period after last dose of study treatment. AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. |
Countries
United States
Outcome results
None listed