NCT03381183

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

A Phase 1b Trial of the IRX-2 Regimen and Durvalumab (MEDI4736), in Patients With Incurable Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Population: Patients with histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of oral cavity, oropharynx, paranasal sinuses, hypopharynx, or larynx that is not amenable to local therapy with curative intent. Squamous cell carcinoma of unknown primary in cervical lymph node can be included only if p16 status is positive.

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

Type	Name	Description
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).

Timeline

• Start date: 2019-08-21
• Primary completion: 2022-05-12
• Completion: 2023-06-30
• First posted: 2017-12-21
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study