Clinical trial NCT03906526: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carcinoma, Squamous Cell
Keywords: Motolimod
Nivolumab
Head and Neck Cancer
Squamous Cell Carcinoma
Checkpoint inhibitor
anti-PD1 inhibitor
TLR 8 agonist
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery
timeFrame: Screening through Study Day 52
Secondary outcomes:
measure: Number of Patients With adverse events that lead to delay in resection
timeFrame: Screening through Study Day 52
measure: Evaluation of safety and tolerability of nivolumab, motolimod and the combination of nivolumab with motolimod
timeFrame: Up to approximately 112 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 112
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 116
state: Massachusetts
city: Saint Louis
country: United States
facility: Local Institution - 102
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Pittsburgh
country: United States
facility: Local Institution - 101
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Hillman Cancer Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Local Institution - 103
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Cancer Center
state: South Dakota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: