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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Celgene
Study ID
NCT03906526
Phase
PHASE1
Status
Terminated

Conditions

  • Carcinoma, Squamous Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VTX-2337 — DRUG
    Motolimod
  • Nivolumab — DRUG
    IV Nivolumab

Study Details

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.

Key Dates

Start date
Jul 3, 2019
Status verified
Feb 2023
Primary completion
Jan 24, 2022
Completion
Jan 24, 2022

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Arm 1: Nivolumab
    Nivolumab IV every 2 weeks
  • Experimental: Monotherapy Arm 2: Motolimod
    Motolimod IT injection weekly
  • Experimental: Combination Arm 3: Nivolumab and Motolimod
    Nivolumab IV every 2 weeks and Motolimod IT injection weekly
  • Experimental: Combination Arm 4: Nivolumab and Motolimod
    Nivolumab IV every 2 weeks and Motolimod SC injection weekly

Primary Outcome Measure

Numbers of CD8+ T cells within the tumor pre-treatment and post-surgery [ Time Frame: Screening through Study Day 52 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Local Institution - 112BirminghamAlabama35294-3300-
University of Alabama at BirminghamBirminghamAlabama35294-3300-
Boston UniversityBostonMassachusetts02215-
Local Institution - 116BostonMassachusetts02215-
Local Institution - 102St LouisMissouri63110-
Washington UniversitySt LouisMissouri63110-
University of CincinnatiCincinnatiOhio45267-0501-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Local Institution - 101PittsburghPennsylvania15232-
University of Pittsburgh Medical Center Hillman Cancer CenterPittsburghPennsylvania15232-
Local Institution - 103Sioux FallsSouth Dakota57104-8805-
Sanford Cancer CenterSioux FallsSouth Dakota57104-8805-

Find similar trials in Birmingham, AL

By research site
Local Institution - 112· Birmingham, ALUniversity of Alabama at Birmingham· Birmingham, ALBoston University· Boston, MALocal Institution - 116· Boston, MALocal Institution - 102· St Louis, MOWashington University· St Louis, MO

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