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IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma

NCT03381183 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-12-05

No results posted yet for this study

Summary

The purpose of this study is to see if the IRX-2 regimen and Durvalumab, will have a tolerable safety profile and will increase the intratumoral immune profile compared with the pretreatment tumors.

Conditions

  • Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Metastatic Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharynx Squamous Cell Carcinoma
  • Paranasal Sinus Squamous Cell Carcinoma
  • Hypopharynx Squamous Cell Carcinoma
  • Larynx Squamous Cell Carcinoma

Interventions

DRUG

Durvalumab

Phase 1 and Phase 2: 1500 mg every 4 weeks (Q4wks).

DRUG

IRX-2 Regimen

Phase 1 and Phase 2 - Every 12 weeks - IRX-2 Regimen: Cyclophosphamide 300 mg/m\^2 - intravenously. IRX-2: 460 units daily (4 injections of 115 units).

Sponsors & Collaborators

  • Brooklyn ImmunoTherapeutics, LLC

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Christine Chung, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-21
Primary Completion
2022-05-12
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT03381183 on ClinicalTrials.gov