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Immunomodulator

CIVO Microdose Injection of Motolimod and Nivolumab for Head and Neck Squamous Cell Carcinoma

Phase < 1
Waitlist Available
Research Sponsored by Presage Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours-4 days after microdose injection
Awards & highlights

Study Summary

This trial is designed to study the biological effects of motolimod and motolimod combined with nivolumab on head and neck squamous cell carcinoma.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours-4 days after microdose injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours-4 days after microdose injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Caspase
Secondary outcome measures
Number of Patients with Adverse Events

Trial Design

1Treatment groups
Experimental Treatment
Group I: CIVO Microdose Injection of Motolimod and NivolumabExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motolimod
2015
Completed Phase 2
~60
Nivolumab
2014
Completed Phase 3
~4740

Find a Location

Who is running the clinical trial?

Presage BiosciencesLead Sponsor
9 Previous Clinical Trials
112 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,830 Total Patients Enrolled
CelgeneIndustry Sponsor
643 Previous Clinical Trials
130,110 Total Patients Enrolled
~0 spots leftby Jun 2025
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