Intratumoral Microdosing of Motolimod in HNSCC

Part of paid clinical trials in San Francisco, California.

Sponsor
Presage Biosciences
Study ID
NCT04272333
Phase
EARLY_PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Motolimod — DRUG
    Intratumoral microdose injection by the CIVO device.
  • Nivolumab — BIOLOGICAL
    Intratumoral microdose injection by the CIVO device.
  • Motolimod + Nivolumab — COMBINATION_PRODUCT
    Intratumoral microdose injection by the CIVO device.

Study Details

This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of motolimod and motolimod combined with nivolumab when administered intratumorally in microdose quantities via the CIVO device in patients with head and neck squamous cell carcinoma (HNSCC). CIVO stands for comparative in vivo oncology.

Key Dates

Start date
Oct 15, 2021
Status verified
Apr 2022
Primary completion
Mar 25, 2022
Completion
Mar 25, 2022

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: CIVO Microdose Injection of Motolimod and Nivolumab
    Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected at least four hours to up to four days prior to surgery using the CIVO device. Each needle of the CIVO device will deliver up to 8.3 microliters of solution, including a vehicle control (sterile saline) or subtherapeutic microdoses of motolimod, nivolumab, or motolimod combined with nivolumab. Each microdose is simultaneously injected in a columnar fashion through each of 8, 5, or 3 needles (in a device configuration determined by tumor dimensions) into a single solid tumor or effaced metastatic lymph node.

Primary Outcome Measure

Quantification of Cell Death and Immune Cell Biomarkers by Immunohistochemistry (IHC) and In-Situ Hybridization (ISH) in Resected Tissue [ Time Frame: 4 hours-4 days after microdose injection ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158-
University of Illinois at ChicagoChicagoIllinois60612-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157-
Oregon Health & Science University (OHSU)PortlandOregon97239-
Portland VAPortlandOregon97239-

Find similar trials in San Francisco, CA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of California, San Francisco· San Francisco, CAUniversity of Illinois at Chicago· Chicago, ILWake Forest Baptist Health· Winston-Salem, NCOregon Health & Science University (OHSU)· Portland, ORPortland VA· Portland, OR

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