NCT03381183 - IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 21, 2019

Primary Completion Date

May 12, 2022

Study Completion Date

June 30, 2023

Conditions

Squamous Cell CarcinomaSquamous Cell Carcinoma of the Head and NeckMetastatic Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaOropharynx Squamous Cell CarcinomaParanasal Sinus Squamous Cell CarcinomaHypopharynx Squamous Cell CarcinomaLarynx 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)."

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa