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Intratumoral Microdosing of Motolimod in HNSCC

NCT04272333 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-04-14

No results posted yet for this study

Summary

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.

Conditions

  • HNSCC

Interventions

DRUG

Motolimod

Intratumoral microdose injection by the CIVO device.

BIOLOGICAL

Nivolumab

Intratumoral microdose injection by the CIVO device.

COMBINATION_PRODUCT

Motolimod + Nivolumab

Intratumoral microdose injection by the CIVO device.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Presage Biosciences

    lead INDUSTRY

Principal Investigators

  • Medical Director · Presage Biosciences

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-03-25
Completion
2022-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272333 on ClinicalTrials.gov