drugset

drugset / Trial / NCT03381183

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

NCT03381183 ↗

Phase 1 Completed 19 enrolled H. Lee Moffitt Cancer Center and Research Institute AstraZeneca · collab Brooklyn ImmunoTherapeutics, LLC · collab

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2019-08-21
Primary completion: 2022-05-12
Completion: 2023-06-30

Publications

Park R, Li J, Slebos RJC, Chaudhary R, Poole MI, Ferraris C, Farinhas J, Hernandez-Prera J, Kirtane K, Teer JK, Song X, Hall MS, Tasoulas J, Amelio AL, Chung CH. Phase Ib trial of IRX-2 plus durvalumab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Oral Oncol. 2024 Jul;154:106866. doi: 10.1016/j.oraloncology.2024.106866. Epub 2024 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	—
Subject	IRX-2	Protein / enzyme biologic	230 unknown	—
Subject	IRX-2	Protein / enzyme biologic	460 unknown	—
Background	Cyclophosphamide	Other / unclassified	300 mg/m2	Intravenous

Indications