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

No Placebo-Only Group

Summary

This trial uses motolimod and a combination of motolimod with nivolumab, injected directly into tumors using a special device. It targets patients with head and neck cancer who are scheduled for surgery. The treatment aims to activate immune cells in the tumor to fight cancer, and the device allows testing of multiple drug effects within the same tumor. Nivolumab has been approved for various cancers and is often combined with other treatments to enhance efficacy.

Eligible Conditions

Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours-4 days after microdose injection

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Caspase

Secondary study objectives

Number of Patients with Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5220